Extra Lutein Formula by CATALO

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Topical calendula has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with mild to moderate acne associated with mask wearing shows that topical application of a combination of calendula 4%, licorice root extract 0.3%, and snail secretion filtrate 40% (AI complex) to the face twice daily for 12 weeks modestly reduces inflammatory, but not non-inflammatory or total, acne lesions when compared with placebo. There was no difference in overall treatment success, defined as at least almost clear skin or a large improvement (110322). It is unclear if any benefits are due to calendula, other ingredients, or the combination.
• Bacterial vaginosis. It is unclear if topical calendula is beneficial for improving bacterial vaginosis. Details: A small clinical study in patients with bacterial vaginosis shows that applying 5 grams of vaginal cream containing calendula flower extract before bed for one week improves vaginal burning, odor, painful urination, and painful intercourse when compared to baseline (96649). The validity of these findings is limited by the lack of a comparator group.
• Burns. It is unclear if oral calendula is beneficial for burn healing. Details: A small clinical trial in patients hospitalized for second-degree burns shows that taking calendula 2 grams daily for 2 weeks has a large beneficial effect on wound healing when compared with placebo (110323).
• Chronic obstructive pulmonary disease (COPD). Oral calendula has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in males aged 40-70 years with a history of smoking and stage 2 COPD shows that taking a specific combination of calendula flowers 165 mg, elderberry 165 mg, and heart's ease herb 165 mg (Inflaminat, INAT-Farma), 3 capsules daily for 6 months, modestly improves symptoms, as measured on the breathlessness, cough, and sputum scale (BCSS), and mean forced expiratory volume in 1 second (FEV1) when compared to baseline. However, there was no improvement of COPD exacerbations or other pulmonary function tests (103629). The validity of this finding is limited by the lack of statistical comparison to the placebo group. Furthermore, it is unclear if these effects are due to calendula, the other ingredients, or the combination.
• Chronic prostatitis and chronic pelvic pain syndrome (CP/CPPS). Calendula in rectal suppositories has only been evaluated in combination with turmeric extract; its effect when used alone is unclear. Details: A small clinical study in patients with CP/CPPS shows that using a rectal suppository containing turmeric extract 350 mg and calendula extract 80 mg daily for one month improves pain, peak urine flow rate, and erectile function when compared with placebo (96648). It is unclear if these effects are due to calendula, turmeric, or the combination.
• Conjunctivitis. Although there is interest in using topical calendula for conjunctivitis, there is insufficient reliable information about the clinical effects of calendula for this condition.
• Diabetic foot ulcers. It is unclear if topical calendula is beneficial for improving diabetic foot ulcers. Details: Observational research has found that applying a calendula hydroglycolic extract spray in addition to standard care and hygiene is associated with reduced bacterial colonization and improved odor in patients that have had a diabetic ulcer for over 3 months (93548).
• Diaper rash. It is unclear if topical calendula is beneficial for improving diaper rash. Details: One preliminary clinical study in children less than 3 years of age shows that topical application of calendula 1.5% ointment three times daily for 10 days improves diaper rash when compared with aloe gel (19779). However, other preliminary clinical research shows that applying calendula 1.5% cream every 4-6 hours for 3 days improves diaper rash in fewer infants when compared to treatment with bentonite 50% mineral solution (93545,93554).
• Dysmenorrhea. Although there is interest in using oral calendula for dysmenorrhea, there is insufficient reliable information about the clinical effects of calendula for this condition.
• Gingivitis. It is unclear if using a mouth rinse with calendula is beneficial for improving gingivitis. Details: Preliminary clinical research in patients with mild gingivitis and bleeding gums shows that rinsing the mouth with a tincture containing calendula 25% (Dr. Willmar Schwabe Germany Home Pharmacy Pvt. Ltd.) twice daily for 6 months decreases plaque, gingivitis, and bleeding by 10% to 18% when compared to rinsing with water (93551). Other preliminary clinical research in adults with mild to moderate gingivitis and mild plaque shows that rinsing the mouth with a combination mouthwash containing a 5% extract of calendula, rosemary, and ginger for 30 seconds twice daily after food for 2 weeks decreases plaque, gingivitis, and bleeding when compared with a placebo mouthwash. The effects of this combination mouthwash appear to be similar to chlorhexidine 0.2% mouthwash (93555). It is unclear if these effects are due to calendula, other ingredients, or the combination.
• Hemorrhoids. Although there is interest in using topical calendula for hemorrhoids, there is insufficient reliable information about the clinical effects of calendula for this purpose.
• Liver disease. Although there is interest in using oral calendula for liver disease, there is insufficient reliable information about the clinical effects of calendula for this condition.
• Mosquito repellent. It is unclear if topical calendula essential oil helps to repel mosquitos. Details: Preliminary clinical research shows that applying calendula 50% essential oil to the skin does not repel mosquitos as effectively as applying DEET. Mean repellency time was about 2 hours for patients applying calendula, which was shorter than the 6 hour repellency with DEET (93562).
• Oral leukoplakia. It is unclear if topical calendula is beneficial for improving oral leukoplakia. Details: Preliminary clinical research in patients with oral leukoplakia shows that applying a gel containing calendula flower extract 0.2% three times daily for one month reduces lesion size by about 2 cm when compared to baseline (96650). The validity of this finding is limited by the lack of a comparator group.
• Oral mucositis. Calendula as a mouth rinse has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with head and neck cancer receiving chemotherapy and radiotherapy shows that rinsing with 7 mL of a specific product (Faringel, Cadigroup) containing calendula powder extract 2%, propolis, aloe vera, and chamomile three times daily for 6 weeks does not prevent oral mucositis when compared with placebo (95879).
• Otitis media. Topical calendula has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in children with otitis media shows that applying a specific combination product containing calendula, mullein, garlic, and St. John's wort in olive oil (Otikon Otic Solution, Healthy-On Ltd, Petach-Tikva, Israel), five drops into the affected ear three times daily for 3 days, may reduce ear pain when compared with baseline (39500,39552). It is unclear if this effect is due to calendula, other ingredients, or the combination. Furthermore, due to the lack of an adequate control group, it is unclear whether the pain reduction was due to the resolution of otitis media.
• Peptic ulcers. Although there is interest in using oral calendula for peptic ulcers, there is insufficient reliable information about the clinical effects of calendula for this condition.
• Pressure ulcers. It is unclear if topical calendula is beneficial for improving pressure ulcers. Details: Observational research has found that the application of a specific calendula product (Plenusdermax) twice daily is associated with improved healing in patients with pressure ulcers that have not changed in size for at least 3 months (93549). Preliminary clinical research in hospice patients with symptomatic pressure ulcers and other wounds shows that applying a homeopathic powder (RGN107) containing calendula 0.1% and arnica 0.01% to wounds for 4 weeks is rated by the patients and caregivers to be acceptable for controlling pain, odor, and exudate when compared with baseline (96647). The validity of this finding is limited by the lack of a control group.
• Radiation dermatitis. It is unclear if topical calendula reduces radiation dermatitis symptoms. Details: A meta-analysis of three preliminary clinical trials in patients with breast cancer shows that topical calendula does not affect the development of radiation dermatitis or the incidence of moderate to severe symptoms when compared to control (110325). In addition, a meta-analysis of two studies (39503,93560) shows that topical calendula does not reduce the incidence of treatment interruptions due to severe symptoms of radiation dermatitis (110325). In one of the included studies, a specific calendula petroleum jelly ointment (Pommade au Calendula par Digestion, Boiron Ltd.) used twice daily during radiation therapy was found to reduce acute radiation dermatitis occurrence when compared with topical trolamine (Biafine) (39503). However, it is unclear if the benefit was due to calendula or petroleum jelly. Another clinical study used a specific calendula 10% cream in wool fat and sesame oil (Calendula Weleda, Weleda AG) twice daily during radiation therapy. This product was found to be no better than aqueous petroleum jelly cream (Essex, Schering-Plough) for reducing acute skin reactions and dermatitis symptoms of pain, burning, itching, pulling, and tenderness (93560).
• Vaginal atrophy. Topical calendula has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in menopausal patients with vaginal atrophy shows that use of a specific vaginal gel containing calendula, Lactobacillus sporogenes, isoflavones, and lactic acid (Estromineral Gel, Rottapharm-Madaus) daily for 4 weeks reduces vaginal itching, burning, dryness, and painful intercourse when compared with no topical treatment. Both groups also received oral isoflavones (39534). It is unclear if these effects are due to calendula, other ingredients, or the combination.
• Vaginal candidiasis. One small clinical study suggest that topical calendula is not beneficial for the treatment of vaginal candidiasis. Details: Preliminary clinical research shows that applying 5 grams of calendula 1% cream intravaginally once daily for 7 days effectively treats vaginal candidiasis in 34% fewer patients when compared with using clotrimazole 1% cream (93559).
• Venous leg ulcers. It is unclear if topical calendula is beneficial for improving venous leg ulcers. Details: Preliminary clinical research shows that applying a calendula 7.5% ointment twice daily for 3 weeks to venous leg ulcers accelerates healing when compared with applying saline solution dressing (39509).
• Wound healing. It is unclear if topical calendula is beneficial for improving the healing of small wounds. Details: Two small clinical trials in postpartum patients show that applying calendula ointment (formulation unspecified) to the episiotomy wound every 8 hours for 5-10 days modestly reduces pain, and seems to speed up the resolution of redness, edema, and ecchymosis, when compared with standard care, such as application of betadine solution (93550,105087). Another small clinical study in adults with wounds smaller than 10 cm² on the hands and fingers shows that applying calendula flower extract 2% to the wound twice daily may modestly improve healing and epithelialization time when compared with mineral oil (107806). More evidence is needed to rate calendula for these uses.

(Read more about CALENDULA)

POSSIBLY EFFECTIVE

• Age-related macular degeneration (AMD). When used alone or in combination with other ingredients, oral lutein seems to improve some aspects of vision in patient with AMD. However, it does not seem to slow the progression of AMD. Details: Epidemiological research has found that people who consume higher amounts of lutein plus zeaxanthin in the diet have a reduced risk of developing AMD (219,2394,60238,106353). The association between intake of lutein specifically and the development of AMD is not clear; however, dietary lutein levels are much higher than dietary zeaxanthin levels. Although one study found no association between increased dietary lutein consumption and a reduced risk for age-related maculopathy, people in this study already had high lutein intake at baseline (14007). Some research has assessed whether lutein supplements can reduce symptoms and progression of existing AMD. Clinical research, including pooled analyses, in adults with AMD shows that taking supplemental lutein 10-20 mg daily for up to 36 months modestly improves some aspects of vision, such as macular pigment optical density, the ability of the eyes to adapt to varying light conditions (glare recovery), the ability to see details of near objects (near vision acuity), and the ability to see under low-contrast conditions (contrast sensitivity) (11798,48213,60185,60242,60245,60268,60270,60280,90678,91160)(91165,97225,102887,106366). Meta-analyses of these and other studies shows that taking lutein or a related xanthophyll carotenoid (zeaxanthin or meso-zeaxanthin) improves macular optical density when compared with placebo in patients with or without AMD. Treatment duration of at least 3 months, doses greater than 5 mg, and/or combination treatment with all three carotenoids are associated with a greater improvement in macular optical density (97225,106366). However, lutein supplements do not appear to affect the progression of AMD (60281). A meta-analysis of 6 studies shows that taking lutein supplements for 0.5-5 years does not reduce the risk of visual loss or progression to late-stage AMD when compared with placebo (95839). Lutein has also been evaluated in combination with other ingredients, with conflicting findings. Although not all research agrees, lutein-containing combination supplements might improve some symptoms of AMD (19196,60134,60180,60207,60237,60244,97226). A specific supplement (AZYR SIFI) containing lutein 10 mg, vitamin C 180 mg, vitamin E 30 mg, zinc 22.5 mg, copper 1 mg, zeaxanthin 1 mg, and astaxanthin 4 mg has been used daily for 1-2 years in some research with moderate evidence of benefit (19196,60244). Taking lutein 10 mg plus zeaxanthin 2 mg in addition to the original Age-Related Eye Disease Study (AREDS) formulation (vitamins C and E, beta carotene, and zinc) does not seem to prevent the progression to advanced AMD more than the AREDS formulation alone. However, this progression was modestly inhibited in individuals with low dietary intakes of lutein and zeaxanthin. While progression to late AMD was only modestly inhibited at 5 years when these doses of lutein and zeaxanthin were included in a revised formulation devoid of beta-carotene (AREDS2) (60281), results of an additional 5 years of follow up showed that this revised formulation reduces the risk of progression to late AMD by 15% when compared with the formulation containing beta-carotene (108615). In first-generation offspring of parents with neovascular AMD, taking lutein 10 mg, zeaxanthin 2 mg, vitamin C 180 mg, vitamin E 30 mg, zinc 15 mg, and copper 1 mg daily for 6 months does not improve the macular pigment optical density (106347). Reasons for these discrepancies are not clear but may relate to lutein dose, dietary lutein intake, treatment duration, or the other ingredients included in the combination products.
• Cataracts. Increased dietary lutein seems to reduce the odds of developing cataracts. It is unclear if oral lutein supplementation is beneficial in those who already have cataracts. Details: Observational research and a meta-analysis of this evidence suggests that higher blood levels and/or higher dietary intake of lutein are associated with a 25% lower odds of developing age-related cataracts, and more specifically, a 25% to 27% decreased risk of developing nuclear cataracts (90944,91161,91162,112095). Population research has also found that people who consume higher amounts of lutein (6.9-11.7 mg daily) as part of their diet have a reduced risk of developing severe cataracts that require surgical removal (2395,3219,3220). Clinical research shows that taking lutein 10 mg and zeaxanthin 2 mg per day orally for an average of 4.7 years decreases the risk of needing cataract surgery by 32% in patients with low dietary intake of lutein and zeaxanthin; however, it doesn't benefit patients with higher dietary intake of lutein and zeaxanthin (94703). Some evidence shows that supplemental lutein might benefit patients who already have cataracts. Preliminary clinical research in adults with grade 2 or 3 senile cataracts shows that taking lutein 15 mg orally three times weekly for up to 2 years can improve the ability to see clearly when compared to baseline (60133).

POSSIBLY INEFFECTIVE

• Bronchopulmonary dysplasia. Oral lutein does not seem to prevent bronchopulmonary dysplasia in preterm and low birth weight infants. Details: Clinical research shows that giving preterm and low birth weight infants a specific product (LUTEINofta, SOOFT Italia SpA) containing lutein 0.14 mg and zeaxanthin 0.0006 mg orally once daily, starting at birth and continuing until 36 weeks corrected gestational age, does not decrease the incidence of bronchopulmonary dysplasia when compared with placebo (91163).
• Necrotizing enterocolitis (NEC). Oral lutein does not seem to prevent NEC in preterm and low birth weight infants. Details: Clinical research shows that giving preterm and low birth weight infants a specific product (LUTEINofta, SOOFT Italia SpA) containing lutein 0.14 mg and zeaxanthin 0.0006 mg orally once daily, starting at birth and continuing until 36 weeks corrected gestational age, does not decrease the incidence of NEC when compared with placebo (91163).
• Retinitis pigmentosa. Oral lutein does not seem to improve vision or slow down retinal degeneration in patients with this condition. Details: While some preliminary clinical evidence suggests that oral lutein might be helpful in the treatment of retinitis pigmentosa (10279), most clinical research shows that taking lutein does not improve vision or other markers of retinal degeneration in patients with retinitis pigmentosa (60117,60165,60225).
• Retinopathy of prematurity. Oral lutein does not seem to prevent retinopathy of prematurity in preterm and low birth weight infants. Details: Clinical research in preterm and low birth weight infants shows that giving 0.5 mL or 1.8 mL/kg of a specific product (LUTEINofta, SOOFT Italia SpA) providing lutein 0.14 mg, or giving 0.5 mg/kg plus zeaxanthin 0.0006 mg or 0.02 mg/kg orally once daily, starting at birth and continuing until 36-40 weeks corrected gestational age, does not decrease the incidence or severity of retinopathy of prematurity when compared with placebo (60240,60243,91163,102889).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related cognitive decline. It is unclear if oral lutein is beneficial for attenuating cognitive decline in older adults. Details: Clinical research in adults 40-75 years old shows that taking lutein 10 mg with zeaxanthin 2 mg daily for 6 months improves some, but not all, measures of visual memory when compared with placebo. However, other measures of memory and cognitive function were not improved (109763). Preliminary clinical research in older adults shows that taking the same dose of lutein and zeaxanthin for one year modestly improves some measures of cognitive function, such as complex attention and cognitive flexibility, when compared with placebo (106367). Other preliminary clinical research in older females shows that taking lutein 12 mg alone or with docosahexaenoic acid (DHA) 800 mg daily for 4 months can improve verbal fluency and memory scores when compared to baseline (48216). Also, some observational research in patients 50 years and older has found that higher dietary lutein and zeaxanthin intake is associated with greater word recall when compared with lower intake (102891). However, clinical research in patients over 60 years old shows that taking lutein 10 mg with zeaxanthin 2 mg daily for 5 years in addition to vitamins C and E, beta-carotene, and zinc (AREDS) does not improve markers of cognitive function, such as memory and verbal fluency, when compared with AREDS alone (94702). More research is needed to determine whether lutein is beneficial for specific measures of cognitive function in older adults.
• Alzheimer disease. Oral lutein has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with mild to moderate Alzheimer disease shows that taking lutein 10 mg, zeaxanthin 2 mg, meso-zeaxanthin 10 mg, fish oil 1 gram (providing docosahexaenoic acid 500 mg and eicosapentaenoic acid 150 mg), and vitamin E 15 mg (Memory Health) daily for 12 months does not affect disease severity when compared with placebo. However, there were modest increases the number of patients experiencing either an improvement or an attenuated decline in memory and mood (109764). The effect of lutein alone is unclear.
• Amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease). It is unclear if oral lutein is beneficial for ALS prevention. Details: Population research has found that higher dietary intake of lutein is associated with a 21% lower risk of developing ALS when compared with lower dietary intake (90412). It is unknown if supplemental lutein has any effect on the risk of developing ALS.
• Asthenopia (eye strain). It is unclear if oral lutein is beneficial for eye strain. Details: Preliminary clinical research shows that some combination lutein supplements might reduce symptoms of eye strain. Results from one clinical trial show that taking a combination product containing lutein, zeaxanthin, and black currant extract daily for 2 weeks improves visual fatigue and eye stress when compared with placebo in patients completing a two-hour visual proof reading task (60214). Other clinical research shows that taking lutein 17.5 mg plus omega-3 fatty acids (standardized to contain docosahexaenoic acid 783 mg and eicosapentaenoic acid 162 mg) and bilberry extract (standardized to contain anthocyanidin 59 mg) daily for 4 weeks reduces symptoms of eye strain when compared with placebo (35470). The effect of lutein alone on eye strain is unclear.
• Asthma. It is unclear if oral lutein is beneficial for asthma prevention. Details: Population research has found that a higher dietary intake of lutein plus zeaxanthin is associated with up to 30% lower odds of having asthma when compared with a lower dietary intake (109765). The effects of lutein intake alone or lutein supplementation are unclear.
• Cardiovascular disease (CVD). Eating more lutein in the diet seems to reduce the risk of CVD. However, taking oral lutein supplements does not seem to prevent CVD events or mortality. Details: One observational study has found that increased intake of dietary lutein is marginally associated with a reduced risk of developing coronary heart disease (14108). A meta-analysis including this and other studies shows that high dietary lutein intake or high lutein serum concentrations are associated with a 12% reduction in the incidence of coronary heart disease, an 18% reduction in stroke, and a 25% reduction in the incidence of metabolic syndrome when compared with low lutein intake or serum concentrations (97227). However, clinical research shows that taking lutein 10 mg plus zeaxanthin 2 mg daily for an average of 4.8 years does not decrease the risk of CVD-related mortality or cardiovascular events such as stroke, myocardial infarction, or angina when compared with no supplementation in patients 50-85 years old (94701). Unlike the analysis above, individual cardiovascular outcomes were not separately evaluated in this study. The effect of lutein on CVD in younger patients or in doses greater than 10 mg is unknown.
• Central serous retinopathy. Oral lutein has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that taking a supplement containing lutein 15 mg, vitamin C 288 mg, vitamin E 150 IU, zinc 9 mg, and copper 1.2 mg (Sante Lutax 15, Santen Pharmaceutical Co. Ltd) three times daily after meals for 6 months has no effect on mean best-corrected visual acuity, serous retinal detachment, or subfoveal fluid remission when compared with placebo in patients with central serous retinopathy (97224).
• Cervical cancer. It is unclear if oral lutein is beneficial for cervical cancer prevention. Details: Epidemiological research has found that low dietary intake of lutein is not associated with an increased risk for developing cervical cancer (60297).
• Child development. It is unclear if oral lutein is beneficial for child development. Details: Epidemiological research has found that a higher dietary intake of lutein in the first and second trimesters of pregnancy is associated with increased verbal intelligence and improved behavior in the child at 6-10 years of age. However, the ability to discriminate between a novel or familiar visual stimulus was reduced at about 6 months of age, and there were no effects on most cognitive outcomes in children aged 3-6 years (107106). Other epidemiological research has found that a higher dietary intake of lutein plus zeaxanthin in children aged 3-6 years may be associated with modestly improved executive function at 6-10 years. However, there were no effects on most cognitive outcomes in children aged 3-6 years or 6-10 years (109761).
• Choroideremia. It is unclear if oral lutein is beneficial for improving vision. Details: Preliminary clinical research shows that taking lutein 20 mg daily for 6 months does not improve vision in patients with choroideremia (60124).
• Cognitive function. It is unclear if oral lutein is beneficial for improving cognitive function. Details: A meta-analysis of clinical research shows that increased dietary lutein does not improve cognitive function measures, such as attention, executive function, or memory, when compared with placebo or an isocaloric meal (107082). However, the dietary source of lutein used in the included studies was heterogeneous and any conclusions remain unclear. Doses of lutein ranged from 8-12 mg daily, alone or in combination with daily zeaxanthin 2-26 mg and/or meso-zeaxanthin 10 mg and docosahexaenoic acid (DHA) 800 mg (107082). However, some preliminary clinical research in younger adults shows that taking lutein 10 mg and zeaxanthin 2 mg for one year modestly improves some measures of cognitive function, such as spatial memory, when compared with placebo (106348). Also, observational research has found that intake of choline and lutein plus zeaxanthin is positively associated with cognitive flexibility task performance speed. However, this association is not present with the intake of lutein plus zeaxanthin in the absence of choline (106354). Reasons for these discrepancies are not clear but may relate to lutein dose, treatment duration, or the addition of other nutrients to the diet or supplements.
• Colorectal cancer. It is unclear if oral lutein is beneficial for colorectal cancer prevention. Details: Some epidemiological research has found that higher dietary intake of lutein is associated with a reduced risk of developing colon cancer (3962). However, most epidemiological research has found that higher dietary intake of lutein is not associated with a reduced risk of colorectal cancer (34481,106372). It is not known if supplemental lutein has any effect on colorectal cancer risk.
• Depression. It is unclear if oral lutein is beneficial for depression. Details: A cross-sectional study in 8655 adults with cardiometabolic disease including diabetes, hypertension, coronary heart disease, heart failure, and stroke suggests that higher dietary lutein and zeaxanthin intake is associated with a 31% reduced risk of depression when compared with lower dietary intake. The study also found that adults with depression had lower dietary lutein and zeaxanthin intake than those without depression. Additionally, the study found a nonlinear U-shaped relationship between total dietary carotenoid intake and the risk of depression among patients with cardiometabolic disease, where the risk of depression decreased with increasing total dietary carotenoid intake up until an inflection point where the risk of depression increased with increasing total dietary carotenoid intake (112098). Further research is needed to establish causality.
• Diabetes. Observational research suggests that oral lutein may not be beneficial for the prevention of diabetes or diabetic complications. Details: Some epidemiological research has found that low serum levels of carotenoids, including lutein, are associated with impaired glucose tolerance. This may indicate that taking carotenoids such as lutein might reduce the risk of diabetes development (60161). However, population research has found that increasing intake of dietary lutein plus zeaxanthin does not decrease the risk of developing type 2 diabetes (14004,97227). Other epidemiological research in patients with type 2 diabetes has found that an increased serum concentration of lutein is not associated with reduced cardiovascular mortality over 14 years (109768).
• Diabetic retinopathy. It is unclear if oral lutein is beneficial in diabetic retinopathy. Details: Preliminary clinical research shows that taking lutein 10 mg daily for 36 weeks has no effect on visual acuity or glare sensitivity in patients with non-proliferative diabetic retinopathy (97223). Observational research in a small group of patients with non-proliferative diabetic retinopathy has also found that taking lutein 4 mg with zeaxanthin 0.5 mg daily for 4 months does not improve visual acuity, contrast sensitivity, or glare sensitivity when compared with zeaxanthin alone (100986).
• Esophageal cancer. It is unclear if oral lutein is beneficial for esophageal cancer prevention. Details: Population research has found that people who consume higher amounts of lutein and zeaxanthin in their diet have a 29% lower risk of developing esophageal squamous cell cancer when compared with those with lower intake (91159). It is unknown if supplemental lutein has any effect on esophageal cancer risk.
• Exercise-induced muscle soreness. It is unclear if oral lutein is beneficial in relieving muscle soreness due to exercise. Details: Some clinical research shows that taking a specific lutein-containing combination product (BioAstin, Cyanotech Corp.) containing haematococcus algae extract with astaxanthin 4 mg and lutein 480 mg daily for 3 weeks prior to exercise does not significantly reduce post-exercise muscle soreness when compared with placebo (19199). The effect of lutein alone is unclear.
• Fractures. It is unclear if oral lutein is beneficial for fracture prevention. Details: A meta-analysis of observational research has found that increased dietary intake of lutein and/or zeaxanthin is not associated with a reduced risk of hip fractures (97228).
• Gastric cancer. It is unclear if oral lutein is beneficial for gastric cancer prevention. Details: A meta-analysis of observational research has found that increased dietary intake of lutein and/or zeaxanthin is not associated with a reduced risk of developing gastric cancer (97231).
• Glaucoma. Oral lutein has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with open-angle glaucoma shows that taking oral lutein 10 mg, zeaxanthin 2 mg, and meso-zeaxanthin 10 mg daily for 18 months increases macular pigment density, but does not affect visual function, when compared with placebo (109756).
• Hyperlipidemia. It is unclear if oral lutein is beneficial for hyperlipidemia. Details: A meta-analysis of clinical research shows that supplementation with lutein does not reduce the levels of total, low-density lipoprotein (LDL), or high-density lipoprotein (HDL) cholesterol when compared with placebo (109757). Most publications included in this analysis evaluated lutein alone in healthy adults or in patients with age-related macular degeneration, two studies combined lutein with another ingredient, and one study evaluated zeaxanthin alone. The effect of lutein in patients with existing hyperlipidemia is unclear.
• Infertility. It is unclear if oral lutein is beneficial for infertility. Details: An observational study suggests that there is no association between dietary lutein intake and in-vitro fertilization (IVF) outcomes including good oocyte quality, embryo transfer success rates, clinical pregnancy rates, and successful term pregnancy rates in subfertile couples who are candidates for IVF (112097).
• Lung cancer. Research is conflicting whether oral lutein is beneficial for lung cancer prevention. Details: Epidemiological research has found that low serum levels of carotenoids, including lutein, are associated with an increased risk of lung cancer (12874). However, other epidemiological research has found that higher serum levels or higher dietary intake of lutein are not associated with a reduced risk of developing or dying from lung cancer (39690,60090,60160). Another large epidemiological cancer screening trial with a mean follow-up of over 12 years suggests that dietary intake of lutein and zeaxanthin is protective against lung cancer as shown by a non-linear dose response curve, where lower doses of lutein and zeaxanthin are associated with a sharp decrease in the incidence of lung cancer, followed by a more gradual decrease in incidence at higher doses (112096).
• Macular telangiectasia type 2. It is unclear if oral lutein is beneficial for macular telangiectasia type 2. Details: In patients with macular telangiectasia type 2, observational research has found that taking a specific combination of lutein 10 mg, meso-zeaxanthin 10 mg, and zeaxanthin 2 mg (MacuShield; Alliance Pharmaceuticals) for at least 6 months, with an average duration of 15.7 months, was associated with a stabilization of visual acuity. Also, the number and size of cavitations in the macula were reduced (106355).
• Metabolic syndrome. Oral lutein has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of observational research shows that high dietary lutein intake or high lutein serum concentrations are associated with a 25% reduction in the incidence of metabolic syndrome when compared with low lutein intake or serum concentrations (97227). Additional population research in females shows that the highest dietary intake of lutein plus zeaxanthin is associated with 54% reduced odds of developing metabolic syndrome when compared with the lowest intake. However, when supplements containing lutein plus zeaxanthin were included in the total intake, there was no association with metabolic syndrome (109760).
• Myopia. It is unclear if oral lutein is beneficial for myopia. Details: A very small clinical study in adults aged 20-50 years with high myopia shows that taking lutein 20 mg daily for 6 months does not improve macular pigment optical density, visual acuity, contrast sensitivity, or electroretinogram measurements when compared with placebo (112099). The validity of these findings is limited by the very small sample size and short study duration.
• Non-Hodgkin lymphoma. It is unclear if oral lutein is beneficial for Non-Hodgkin lymphoma prevention. Details: A meta-analysis of observational population research has found that increased intake of lutein/zeaxanthin in the diet is associated with an 18% lower risk of developing non-Hodgkin lymphoma when compared with low dietary intake. However, no dose-response relationship was reported (97229). It is unknown if supplemental lutein has any effect on non-Hodgkin lymphoma risk.
• Obesity. It is unclear if oral lutein is beneficial for obesity. Details: A small clinical trial in obese middle-aged individuals shows that taking lutein 20 mg daily in addition to following a low-calorie diet for 10 weeks does not affect most anthropometric or cardiometabolic indices when compared with a low-calorie diet alone. However, there was a small beneficial effect on body fat and total cholesterol levels (107107).
• Pancreatic cancer. It is unclear if oral lutein is beneficial for pancreatic cancer prevention. Details: A meta-analysis of population research has found that increased dietary intake of lutein and/or zeaxanthin is not associated with a reduced risk of pancreatic cancer (97230). The effects of supplemental lutein are unclear.
• Parkinson disease. It is unclear if oral lutein is beneficial for Parkinson disease prevention. Details: Population research has found that higher dietary intake of lutein is not associated with the risk of developing Parkinson disease (91164). The effects of supplemental lutein are unclear.
• Pre-eclampsia. It is unclear if oral lutein is beneficial for pre-eclampsia prevention. Details: Some epidemiological research has found that high plasma concentrations of lutein are associated with a decreased risk of pre-eclampsia (60142). Other epidemiological research has found that the highest dietary intake of lutein plus zeaxanthin during pregnancy is associated with 68% reduced odds of having pre-eclampsia when compared with the lowest intake (109762). The effects of lutein supplements are unclear.
• Respiratory tract infections. It is unclear if oral lutein is beneficial in respiratory tract infection prevention or treatment. Details: Epidemiological research has found that high serum levels of lutein are not associated with a decreased incidence or severity of respiratory tract infections in the elderly (60152). The effects of supplemental lutein are unclear.
• Ulcerative colitis. It is unclear if oral lutein is beneficial for ulcerative colitis. Details: In patients in the remission phase of ulcerative colitis, observational research has found that a higher dietary intake of lutein plus zeaxanthin is associated with a reduced incidence of constipation, but not flatulence or feelings of urgency (tenesmus) (106362). The effects of supplemental lutein are unclear.
• Visual development. It is unclear if taking oral lutein during pregnancy can improve the visual acuity of the child. Details: Some observational research has found that higher maternal lutein levels are associated with a 22% to 40% lower risk of poor visual acuity in children at 3 years of age when compared with lower maternal lutein levels (102888). However, other epidemiological research has found that dietary intake of lutein plus zeaxanthin during the first or third trimesters of pregnancy is not associated with contrast vision or visual acuity in the child at 11-12 years of age (109759). The effects of lutein supplements are unclear. More evidence is needed to rate lutein for these uses.

(Read more about LUTEIN)

There is insufficient reliable information available about the effectiveness of ornamental marigold.

(Read more about ORNAMENTAL MARIGOLD)

POSSIBLY EFFECTIVE

• Age-related macular degeneration (AMD). Oral zeaxanthin, when used in low levels as part of multi-ingredient products containing lutein, seems to improve some aspects of vision in patient with AMD. It is unclear if oral zeaxanthin alone or in amounts similar to lutein is beneficial for slowing AMD progression. Details: Epidemiological research has found that people who consume higher amounts of zeaxanthin plus lutein in the diet have a reduced risk of developing late AMD, but not early or intermediate AMD (60238,106353,106359). However, any association between intake of zeaxanthin itself and the development of AMD is not clear. Some clinical research has assessed whether zeaxanthin alone can reduce symptoms and progression of AMD. A small clinical trial shows that taking supplemental zeaxanthin 8 mg daily for 12 months modestly improves some aspects of vision, such as macular pigment optical density, the ability to see details of near objects (near vision acuity), and resolution of scotoma (blind spot), when compared with placebo in patients with AMD (60245). Other clinical research in a healthy population shows that taking zeaxanthin alone (Optisharp) as 10 mg daily for 6-12 months increases macular pigment optical density (60175). Most clinical research in patients with AMD has assessed zeaxanthin in combination with lutein. In general, this combination has been shown to increase macular pigment optical density, as well as the ability to see under low-contrast conditions (contrast sensitivity) and visual acuity. However, most research has used much higher doses of lutein compared with zeaxanthin (60281,91160,97225,106366,108615). Use of near equal amounts, such as zeaxanthin 8-10 mg daily plus lutein 9-10 mg daily for up to 2 years, seems to improve macular density in adults with or without AMD (60175,60268,60270,106358); however, effects on vision when used for up to 2 years in patients with AMD are conflicting (60245,60268,60270,106358). Zeaxanthin has also been evaluated in combination with other ingredients, with conflicting findings. A specific supplement (AZYR SIFI) containing zeaxanthin 1 mg, lutein 10 mg, vitamin C 180 mg, vitamin E 30 mg, zinc 22.5 mg, copper 1 mg, and astaxanthin 4 mg has been used daily for 1-2 years with moderate evidence of benefit (19196,60244). Taking zeaxanthin 2 mg plus lutein 10 mg in addition to the original Age-Related Eye Disease Study (AREDS) formulation (vitamins C and E, beta-carotene, and zinc) does not seem to prevent the progression to advanced AMD more than the AREDS formulation alone. However, this progression was modestly inhibited in individuals with low dietary intakes of lutein and zeaxanthin. While progression to late AMD was only modestly inhibited at 5 years when these doses of lutein and zeaxanthin were included in a revised formulation devoid of beta-carotene (60281), results of an additional 5 years of follow up showed that this revised formulation reduces the risk of progression to late AMD by 15% when compared with the formulation containing beta-carotene (108615). Clinical research shows that adding meso-zeaxanthin 10 mg to this revised AREDS formulation (AREDS2) does not further improve contrast sensitivity in patients with non-advanced AMD (106369). In first-generation offspring of parents with neovascular AMD, taking zeaxanthin 2 mg, lutein 10 mg, vitamin C 180 mg, vitamin E 30 mg, zinc 15 mg, and copper 1 mg daily for 6 months does not improve the macular pigment optical density (106347). Reasons for these discrepancies are not clear but may relate to the patient population, zeaxanthin dose, treatment duration, or other ingredients included in combination products.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related cognitive decline. It is unclear if oral zeaxanthin is beneficial for attenuating cognitive decline in older adults. Details: Clinical research in adults 40-75 years old shows that taking zeaxanthin 2 mg with lutein 10 mg daily for 6 months improves some, but not all, measures of visual memory when compared with placebo. However, other measures of memory and cognitive function were not improved (109763). Also, preliminary clinical research in older adults shows that taking the same dose of zeaxanthin and lutein for one year modestly improves some measures of cognitive function, such as complex attention and cognitive flexibility, when compared with placebo (106367). Some observational research in patients 50 years and older has found that higher dietary lutein and zeaxanthin intake is associated with greater word recall when compared with lower intake (102891). However, clinical research in patients over 60 years old shows that taking zeaxanthin 2 mg with lutein 10 mg daily for 5 years in addition to vitamins C and E, beta-carotene, and zinc (AREDS) does not improve markers of cognitive function, such as memory and verbal fluency, when compared with AREDS alone (94702).
• Alzheimer disease. Oral zeaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with mild to moderate Alzheimer disease shows that taking zeaxanthin 2 mg, lutein 10 mg, meso-zeaxanthin 10 mg, fish oil 1 gram (providing docosahexaenoic acid 500 mg and eicosapentaenoic acid 150 mg), and vitamin E 15 mg (Memory Health) daily for 12 months does not affect disease severity when compared with placebo. However, there were modest increases in the number of patients experiencing either an improvement or attenuated decline in memory and mood (109764). The effect of zeaxanthin alone is unclear.
• Asthenopia (eye strain). Oral zeaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Results from one clinical trial show that taking a combination product (Cerebos Pacific Limited) containing zeaxanthin 1 mg, lutein 5 mg, and black currant extract 200 mg daily for 2 weeks modestly improves visual fatigue and eye stress when compared with placebo in patients completing a two-hour visual proof reading task (60214). The effect of zeaxanthin alone on eye strain is unclear.
• Asthma. It is unclear if oral zeaxanthin is beneficial for asthma prevention. Details: Population research has found that a higher dietary intake of zeaxanthin plus lutein is associated with up to 30% lower odds of having asthma when compared with a lower dietary intake (109765). The effects of zeaxanthin intake alone or zeaxanthin supplementation are unclear.
• Breast cancer. It is unclear if oral zeaxanthin is beneficial for breast cancer prevention. Details: Epidemiological research has found that higher serum levels of lutein plus zeaxanthin are associated with a reduced risk of developing breast cancer (10132). The effects of supplemental zeaxanthin are unclear.
• Bronchopulmonary dysplasia. Oral zeaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that giving preterm and low birth weight infants a specific product (LUTEINofta, SOOFT Italia SpA) containing zeaxanthin 0.0006 mg and lutein 0.14 mg orally once daily, starting at birth and continuing until 36 weeks' corrected gestational age, does not decrease the incidence of bronchopulmonary dysplasia when compared with placebo (91163). The effect of zeaxanthin alone is unclear.
• Cardiovascular disease (CVD). Oral zeaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in adults 50-85 years old shows that taking lutein 10 mg plus zeaxanthin 2 mg daily for an average of 4.8 years does not decrease the risk of CVD-related mortality or cardiovascular events such as stroke, myocardial infarction, or angina when compared with no supplementation (94701). Individual cardiovascular outcomes were not separately evaluated in this study. The effect of zeaxanthin alone on CVD prevention is unknown.
• Cataracts. Increased levels of zeaxanthin in the blood seems to reduce the odds of developing cataracts. It is unclear if dietary or supplemental zeaxanthin is beneficial for cataract treatment or prevention. Details: Some population research has found that higher blood levels of zeaxanthin are associated with a 30% lower odds of developing age-related cataracts, and more specifically, a 37% decreased risk of developing nuclear cataracts (90944,91161). Population research has also found that higher dietary combined intake of lutein plus zeaxanthin is associated with lower odds of developing cataracts. However, any association between intake of zeaxanthin itself and the development of cataracts is unclear (91162). Clinical research shows that taking zeaxanthin 2 mg and lutein 10 mg daily orally, in addition to the Age-Related Eye Disease Study (AREDS) formulation containing vitamin C 500 mg, vitamin E 400 IU, beta-carotene 15 mg, zinc 80 mg, and copper 2 mg, for an average of 4.7 years decreases the risk of needing cataract surgery by 32% when compared with the AREDS formulation alone in patients with low dietary intake of lutein and zeaxanthin, but not in those with higher dietary intake of lutein and zeaxanthin (94703).
• Child development. It is unclear if oral zeaxanthin is beneficial for child development. Details: Epidemiological research has found that a higher dietary intake of zeaxanthin in the first and second trimesters of pregnancy is associated with increased verbal intelligence and improved behavior in the child at 6-10 years of age. However, the ability to discriminate between a novel or familiar visual stimulus was reduced at about 6 months of age, and there were no effects on most cognitive outcomes in children aged 3-6 years (107106). Other epidemiological research has found that a higher dietary intake of zeaxanthin plus lutein in children aged 3-6 years may be associated with modestly improved executive function at 6-11 years. However, there were no effects on most cognitive outcomes in children aged 3-6 years or 6-11 years (109761).
• Cognitive function. Oral zeaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in younger adults shows that taking zeaxanthin 2 mg and lutein 10 mg for one year modestly improves some measures of cognitive function, such as spatial memory, when compared with placebo (106348). Observational research has found that intake of choline and lutein plus zeaxanthin is positively associated with cognitive flexibility task performance speed. However, this association is not present with the intake of lutein plus zeaxanthin in the absence of choline (106354). The effect of zeaxanthin alone is unclear.
• Colorectal cancer. It is unclear if oral zeaxanthin is beneficial for colorectal cancer prevention. Details: Although some individual epidemiological research disagrees (3962), most research has found that dietary intake of lutein plus zeaxanthin is not associated with a reduced risk of developing colorectal cancer (34481,106372). However, any association with intake of zeaxanthin alone, as supplements or in the diet, is unclear.
• Diabetes. Observational research suggests that oral zeaxanthin may not be beneficial for the prevention of diabetes or diabetic complications. Details: Some epidemiological research has found that low serum levels of carotenoids, including zeaxanthin and lutein, are associated with impaired glucose tolerance (60161). Other population research has found that increased dietary intake of zeaxanthin plus lutein does not decrease the risk of developing type 2 diabetes (14004,97227). Other epidemiological research in patients with type 2 diabetes has found that an increased serum concentration of zeaxanthin is not associated with reduced cardiovascular mortality over 14 years (109768).
• Esophageal cancer. It is unclear if oral zeaxanthin is beneficial for esophageal cancer prevention. Details: Population research has found that people who consume higher combined amounts of zeaxanthin and lutein in the diet have a 29% lower risk of developing esophageal squamous cell cancer when compared with lower intake (91159). The effects of supplemental zeaxanthin are unclear.
• Fractures. It is unclear if oral zeaxanthin is beneficial for fracture prevention. Details: A meta-analysis of observational research has found that increased dietary intake of zeaxanthin and/or lutein is not associated with a reduced risk of hip fractures (97228). The effects of supplemental zeaxanthin are unclear.
• Gastric cancer. It is unclear if oral zeaxanthin is beneficial for gastric cancer prevention. Details: A meta-analysis of observational research has found that increased dietary intake of lutein and/or zeaxanthin is not associated with a reduced risk of developing gastric cancer (97231). The effects of supplemental zeaxanthin are unclear.
• Glaucoma. Oral zeaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with open-angle glaucoma shows that taking oral zeaxanthin 2 mg, lutein 10 mg, and meso-zeaxanthin 10 mg daily for 18 months increases macular pigment density, but does not affect visual function, when compared with placebo (109756).
• Hyperlipidemia. Although there has been interest in using oral zeaxanthin for hyperlipidemia, there is insufficient reliable information about the clinical effects of zeaxanthin for this condition.
• Lung cancer. It is unclear if oral zeaxanthin is beneficial for lung cancer prevention. Details: Epidemiological research has found that low serum levels of carotenoids, including zeaxanthin, are associated with an increased risk of lung cancer (12874). However, other epidemiological research has found that higher serum levels of zeaxanthin are not associated with a reduced risk of dying from lung cancer (39690,60160).
• Macular telangiectasia type 2. It is unclear if oral zeaxanthin is beneficial for macular telangiectasia type 2. Details: In patients with macular telangiectasia type 2, observational research has found that taking a specific combination of lutein 10 mg, meso-zeaxanthin 10 mg, and zeaxanthin 2 mg (MacuShield; Alliance Pharmaceuticals) for at least 6 months, with an average duration of 15.7 months, was associated with a stabilization of visual acuity. Also, the number and size of cavitations in the macula were reduced (106355).
• Metabolic syndrome. Oral zeaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Population research in females shows that the highest dietary intake of zeaxanthin plus lutein is associated with 54% reduced odds of developing metabolic syndrome when compared with the lowest intake. However, when supplements containing zeaxanthin plus lutein were included in the total intake, there was no association with metabolic syndrome (109760).
• Necrotizing enterocolitis (NEC). Oral zeaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that giving preterm and low birth weight infants a specific product (LUTEINofta, SOOFT Italia SpA) containing zeaxanthin 0.0006 mg and lutein 0.14 mg orally once daily, starting at birth and continuing until 36 weeks' corrected gestational age, does not decrease the incidence of NEC when compared with placebo (91163).
• Non-Hodgkin lymphoma. It is unclear if oral zeaxanthin is beneficial for non-Hodgkin lymphoma prevention. Details: A meta-analysis of observational research has found that increased intake of zeaxanthin/lutein in the diet is associated with an 18% lower risk of developing non-Hodgkin lymphoma when compared with low dietary intake. However, no dose-response relationship was reported (97229). It is unknown if supplemental zeaxanthin has any effect on non-Hodgkin lymphoma risk.
• Pancreatic cancer. It is unclear if oral zeaxanthin is beneficial for pancreatic cancer prevention. Details: A meta-analysis of population research has found that increased dietary intake of zeaxanthin and/or lutein is not associated with a reduced risk of pancreatic cancer (97230). The effects of supplemental zeaxanthin are unclear.
• Parkinson disease. It is unclear if oral zeaxanthin is beneficial for Parkinson disease prevention. Details: Population research has found that people who consume higher amounts of zeaxanthin in the diet do not have a lower risk of developing Parkinson disease (91164). The effects of supplemental zeaxanthin are unclear.
• Pre-eclampsia. It is unclear if oral zeaxanthin is beneficial for the prevention of pre-eclampsia. Details: Some epidemiological research has found that the highest intake of lutein plus zeaxanthin during pregnancy is associated with 68% reduced odds of having pre-eclampsia when compared with the lowest intake (109762). The effects of zeaxanthin supplements are unclear.
• Prostate cancer. It is unclear if oral zeaxanthin is beneficial for prostate cancer prevention. Details: Epidemiological research has found that low serum levels of carotenoids, including zeaxanthin, are not associated with an increased risk of prostate cancer (12874). The effects of supplemental zeaxanthin are unclear.
• Respiratory tract infections. It is unclear if oral zeaxanthin is beneficial for the treatment or prevention of respiratory tract infections. Details: Epidemiological research has found that high serum levels of zeaxanthin are not associated with decreased incidence or severity of respiratory tract infections in the elderly (60152). The effects of supplemental zeaxanthin are unclear.
• Retinopathy of prematurity. Oral zeaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in preterm and low birth weight infants shows that giving a specific product (LUTEINofta, SOOFT Italia SpA) providing lutein 0.14 mg or 0.5 mg/kg plus zeaxanthin 0.0006 mg or 0.02 mg/kg orally once daily, starting at birth and continuing until 36-40 weeks' corrected gestational age, does not decrease the incidence or severity of retinopathy of prematurity when compared with placebo (60240,60243,91163,102889).
• Ulcerative colitis. It is unclear if oral zeaxanthin is beneficial for ulcerative colitis. Details: In patients in the remission phase of ulcerative colitis, observational research has found that a higher dietary intake of lutein plus zeaxanthin is associated with a reduced incidence of constipation, but not flatulence or feelings of urgency (tenesmus) (106362). The effects of supplemental zeaxanthin are unclear.
• Visual development. It is unclear if taking oral zeaxanthin during pregnancy can improve the visual acuity of the child. Details: Some observational research has found that the highest maternal plasma zeaxanthin levels at delivery are associated with a 38% lower risk of poor visual acuity in children at 3 years of age when compared with the lowest maternal zeaxanthin levels (102888). However, other epidemiological research has found that dietary intake of zeaxanthin plus lutein during the first or third trimesters of pregnancy is not associated with contrast vision or visual acuity in the child at 11-12 years of age (109759). The effects of zeaxanthin supplements are unclear. More evidence is needed to rate zeaxanthin for these uses.

(Read more about ZEAXANTHIN)

LIKELY SAFE ...when the flower preparations are used orally or topically and appropriately (4,19779,36931,39503,93552,93557,96647,105088).

PREGNANCY: LIKELY UNSAFE
when used orally; contraindicated due to spermatocide, antiblastocyst, and abortifacient effects. There is insufficient reliable information available about the safety of calendula when used topically during pregnancy (4).

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about CALENDULA)

LIKELY SAFE ...when used orally and appropriately. Consuming up to 20 mg of lutein daily from both dietary and supplemental sources appears to be safe (3219,3220,60167). Lutein supplements have been safely used in clinical trials at doses of up to 20 mg daily for up to 10 years (11798,60133,60177,94703,94701,100986,104570,107107,108615,109763).

CHILDREN: LIKELY SAFE
when used orally and appropriately. A specific product containing lutein (LUTEINofta, SOOFT Italia SpA) has been used with apparent safety in infants at a dose of 0.14 mg daily for 36 weeks (91163).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately in amounts found in foods. The high end of dietary lutein intake ranges from 6.9-11.7 mg/day (3219,3220).

(Read more about LUTEIN)

LIKELY SAFE ...when used orally in amounts commonly found in foods. Tagetes has Generally Recognized as Safe (GRAS) status in the US (4912). There is insufficient reliable information available about the safety of tagetes used in amounts greater than those found in foods.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid amounts greater than those commonly found in foods.

(Read more about ORNAMENTAL MARIGOLD)

LIKELY SAFE ...when used orally and appropriately in doses of up to 2 mg daily. Zeaxanthin supplements have been safely used in clinical trials at doses of up to 2 mg daily for up to 10 years (94701,94702,94703,108615).

POSSIBLY SAFE ...when used orally and appropriately in amounts greater than 2 mg daily. Zeaxanthin supplements in doses of 8-10 mg daily for up to 12 months have been used with apparent safety in clinical trials (60175,60245).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately. A specific product containing zeaxanthin (LUTEINofta, SOOFT Italia SpA) has been used with apparent safety in infants at a dose of 0.0006 mg daily for 36 weeks (91163). There is insufficient reliable information available about the safety of zeaxanthin at higher doses or in older children.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately in amounts found in foods. Zeaxanthin is found in breast milk and levels correlate with infant status (106365). There is insufficient reliable information available about the safety of supplemental zeaxanthin.

(Read more about ZEAXANTHIN)

CNS DEPRESSANTS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, calendula might have additive effects when used with CNS depressants, although this appears to be unlikely.  Details Although some animal research has suggested that a saponoside constituent in calendula may have sedative effects (39545,39547), calendula has been used for over 30 years without reports of sedation in humans (105088).

(Read more about CALENDULA)

(Read more about LUTEIN)

(Read more about ORNAMENTAL MARIGOLD)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking zeaxanthin with antidiabetes drugs might increase the risk of hypoglycemia.  Details In an animal diabetic model, zeaxanthin has hypoglycemic effects (106363). However, population research has found that increasing intake of dietary zeaxanthin plus lutein does not decrease the risk of developing type 2 diabetes (14004,97227).

(Read more about ZEAXANTHIN)

General ...Orally and topically, calendula is generally well tolerated.
Serious Adverse Effects (Rare):
All ROAs: Allergic reactions.

Dermatologic ...Topically, a preparation containing calendula powder 0. 1% resulted in inflammation around the wound to which it was applied (96647). Burning sensation, itching, redness, and scaling were reported rarely in patients applying a combination of calendula, licorice, and snail secretion filtrate to the face. The specific role of calendula is unclear (110322).

Immunologic ...Orally, calendula can cause allergic reactions. Topically, calendula can cause eczematous allergic reactions. Calendula-specific patch testing is recommended prior to usage to determine allergenic potential. Testing is particularly necessary in individuals sensitive to the Asteraceae/Compositae family (10691,11458,96647). Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs. A preparation containing calendula powder 0.1% resulted in hives in a patient with a ragweed allergy (96647). Despite the widespread use of calendula and the occurrence of allergies to other family members, there has been only one report of anaphylaxis (11152).

(Read more about CALENDULA)

General ...Orally, dietary and supplemental lutein is generally well tolerated. Doses up to 20 mg daily have not resulted in adverse effects.

(Read more about LUTEIN)

General ...Orally, ornamental marigold is well tolerated in amounts found in foods. No adverse effects have been reported when used in amounts greater than those found in foods. A thorough evaluation of safety outcomes has not been conducted. Topically, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Topically: Contact dermatitis.

Dermatologic ...Topically, ornamental marigold has been reported to cause contact dermatitis (11).

Immunologic ...Ornamental marigold can cause an allergic reaction in individuals sensitive to the Asteraceae/Compositae family. Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs (11).

(Read more about ORNAMENTAL MARIGOLD)

General ...Orally, dietary and supplemental zeaxanthin are generally well tolerated. No adverse effects have been reported in clinical research.

(Read more about ZEAXANTHIN)