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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Dyspepsia. Oral olive leaf extract has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small study in healthy adults shows that taking a specific combination product containing olive leaf extract 24% and prickly pear cactus 33% (Mucosave, Bionap S.R.L.) 400 mg daily for 8 weeks seems to improve dyspepsia and other gastrointestinal symptoms when compared with placebo (105904). It is unclear if this benefit would occur in patients with clinically diagnosed dyspepsia.
• Exercise-induced respiratory infections. It is unclear if oral olive leaf extract is beneficial for reducing respiratory infections from exercise. Details: A small clinical study in high school athletes shows that taking one tablet of olive leaf extract providing eleuropein 100 mg daily for 2 months during training season does not reduce the incidence of the common cold when compared with placebo. While it may reduce the number of sick days by 28%, a sub-group analysis suggests that this reduction is only evident in female athletes (101860).
• Gastroesophageal reflux disease (GERD). Although there is interest in using oral olive leaf for GERD, there is insufficient reliable information about the clinical effects of olive for this condition.
• Herpes zoster (shingles). Although there is interest in using oral olive leaf for shingles, there is insufficient reliable information about the clinical effects of olive for this condition.
• Influenza. Although there is interest in using oral olive leaf for influenza, there is insufficient reliable information about the clinical effects of olive for this condition.
• Metabolic syndrome. It is unclear if oral olive leaf extract is beneficial for improving body composition and cardiovascular risk factors in patients with metabolic syndrome. Details: A small clinical trial in overweight, middle-aged males at risk for metabolic syndrome shows that taking four capsules of olive leaf extract providing oleuropein 51.1 mg and hydroxytyrosol 9.7 mg daily for 12 weeks improves insulin sensitivity by 15% when compared with placebo. However, body composition, blood pressure, cholesterol levels, and other cardiovascular risk factors were not improved (92245).
• Osteoarthritis. It is unclear if oral olive fruit or leaf extract is beneficial for improving osteoarthritis. Details: Preliminary clinical research shows that taking a freeze-dried aqueous extract of olive fruit 400 mg daily for 8 weeks decreases pain and increases mobility in people with osteoarthritis (14844). Other preliminary clinical research in adults with knee osteoarthritis shows that taking olive leaf extract 50.1 mg daily for 4 weeks improves overall pain measurements by 14%, compared to only 4% in the placebo group. However, many individual measurements of pain are not improved (92252).
• Osteoporosis. It is unclear if oral olive leaf extract is beneficial for osteoporosis. Details: Clinical research shows that taking olive leaf extract (Bonolive, BioActor BV) 250 mg daily for 12 months, along with elemental calcium 400 mg daily, increases osteocalcin levels by about 32% when compared to baseline; this increase was significant when compared to those taking calcium 400 mg plus placebo, who showed a 6% decrease in osteocalcin levels. However, taking olive leaf extract does not significantly increase bone mineral density of the lumbar spine or femur neck when compared with placebo (92247).
• Rheumatoid arthritis (RA). It is unclear if oral olive fruit extract is beneficial for improving RA symptoms. Details: Preliminary clinical research in adults with RA shows that taking an aqueous freeze-dried extract of olive fruit 400 mg daily for 8 weeks does not improve symptoms when compared with control (14844). More evidence is needed to rate the effectiveness of olive for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. It is unclear if oral sweet almond is beneficial in patients with aging skin. Details: Preliminary clinical research in postmenopausal females shows that consuming sweet almonds as 20% of daily energy intake for 16 weeks reduces wrinkle severity scores by approximately 8% when compared with consuming a calorie-matched snack (101756).
• Atopic dermatitis (eczema). Topical sweet almond oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with xerotic eczema shows that applying an emollient containing lactic acid 5% and refined sweet almond oil 10%, with or without polidocanol 5%, twice daily (Antidry Lotion or Antidry Calm) for 2 weeks reduces itching by up to 69% when compared with baseline. Benefits occurred within 30 minutes of the first use and seemed to be related to improved moisture and lipid content of the skin (101788).
• Attention deficit-hyperactivity disorder (ADHD). It is unclear if oral sweet almond extract is beneficial in patients with ADHD. Details: Preliminary clinical research in children aged 6-14 years old with ADHD shows that taking sweet almond extract syrup, 5 mL three times daily, for 8 weeks does not affect parent- or teacher-rated hyperactivity or inattention scores when compared with methylphenidate 1 mg/kg orally daily. This study may have been inadequately powered to detect a difference between groups (101783).
• Cancer. Although there has been interest in using oral sweet almond for cancer, there is insufficient reliable information about the clinical effects of sweet almond for this purpose.
• Cardiovascular disease (CVD). Although there has been interest in using oral sweet almond for CVD, there is insufficient reliable information about the clinical effects of sweet almond for this purpose.
• Coronary heart disease (CHD). It is unclear if oral sweet almond is beneficial for the prevention or treatment of CHD. Details: A small clinical trial in patients with hypercholesterolemia has found that intake of sweet almonds for 4 weeks is associated with decreased CHD risk based on the Framingham 10-year risk score. Each 30-gram intake of sweet almonds was associated with an estimated 3.5% decrease in risk scores (99940). In 2003, the US Food and Drug Administration (FDA) determined that it would allow a qualified health claim stating that consuming 1.5 ounces of almonds per day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD. However, the FDA has concluded that this claim is based on supporting, rather than conclusive, evidence (102331). It is unclear if sweet almonds improve outcomes in patients with CHD. Preliminary clinical research in adults with CHD shows that incorporating sweet almonds 85 grams daily into a National Cholesterol Education Program (NCEP) Step I diet for 6 weeks does not improve total or low-density lipoprotein (LDL) cholesterol, blood pressure, vascular function, or inflammatory markers when compared to the NCEP Step 1 diet without sweet almonds (99938). However, the short duration of this study limits the validity of the findings.
• Constipation. It is unclear if oral or topical sweet almond is beneficial in patients with constipation. Details: A small single-blinded clinical study in older adults with constipation shows that taking sweet almond oil 9 mL twice daily or abdominal massage with 18 mL of sweet almond oil every other day for 2 weeks both independently improve symptoms of constipation, stool consistency, and quality of life when compared with no treatment. Improvement in constipation and quality of life were also superior with oral sweet almond oil over sweet almond oil massage (111392). The validity of these findings is limited by a lack of placebo control.
• Diabetes. It is unclear if oral sweet almond is beneficial in patients with diabetes. Details: Research on whether sweet almond improves glycemic control in patients with diabetes is conflicting. A small study in patients with type 2 diabetes and mild hyperlipidemia shows that consuming sweet almonds as 20% of energy intake (approximately 60 grams daily) as part of a National Cholesterol Education Program (NCEP) Step II diet for 4 weeks, along with hypoglycemic medications, improves measures of glycemic control, as well as lipids and adiposity. Fasting insulin and glucose levels decreased by 4% and 1%, respectively, when compared with the diet without sweet almonds. Also, low-density lipoprotein (LDL) cholesterol levels were reduced by about 12% (99941). Preliminary clinical research also shows that regularly consuming sweet almonds as part of a low-carbohydrate diet for 12 weeks is more effective than consuming cheese, but no more effective than peanuts, for reducing glycated hemoglobin (HbA1c) levels (99943,101787). However, the change in HbA1c demonstrated in these small trials may not be considered clinically relevant. In contrast, meta-analyses of many clinical trials in patients with a variety of metabolic disorders, including diabetes, shows that eating almonds 5-85 grams daily, or as 10% to 20% of energy, for 4-24 weeks does not improve fasting blood glucose levels, HbA1c, insulin levels, or measures of insulin resistance when compared with control (109019,111395).
• Hyperlipidemia. Small clinical studies suggest that oral sweet almond might reduce total cholesterol and low-density lipoprotein (LDL) cholesterol in patients with hyperlipidemia, but it does not appear to improve other lipid levels in these patients. Details: Several small clinical studies in adults with hyperlipidemia show that consuming raw sweet almonds 42.5-100 grams or taking sweet almond oil 10 mL daily for 4-9 weeks reduces low-density lipoprotein (LDL) cholesterol levels by 3% to 15% when compared with control diets or baseline levels. Most of these studies failed to show improvements in high-density lipoprotein (HDL) cholesterol levels or triglyceride levels when compared with control (76725,76737,99939,101786), although one study showed a 4% improvement in HDL levels (99940). A meta-analysis of 8 clinical trials in patients with hyperlipidemia or in which at least half of the patients were classified as having hyperlipidemia shows that consuming sweet almonds or taking sweet almond oil daily for 4-12 weeks modestly reduces total cholesterol and LDL cholesterol but does not improve very low-density lipoprotein (VLDL) cholesterol, triglycerides, or HDL cholesterol when compared with placebo or no treatment (111395).
• Hypertension. It is unclear if oral sweet almond is beneficial in patients with hypertension. Details: A meta-analysis of 10 small clinical studies in which at least half of the patients in each study were classified as having hypertension at baseline shows that taking sweet almond does not improve systolic or diastolic blood pressure when compared with placebo or no treatment (111395). The validity of these findings is limited by a high degree of heterogeneity across the studies.
• Insomnia. It is unclear if oral sweet almond is beneficial in patients with insomnia. Details: Preliminary clinical research in students shows that consuming ten sweet almonds daily for 2 weeks reduces the percentage of students reporting insomnia on sleep surveys from 78% to 69% (101784). The validity of this study is limited by the lack of a control group.
• Impaired glucose tolerance (prediabetes). It is unclear if oral sweet almond is beneficial in patients with prediabetes. Details: A small clinical study in adults with prediabetes shows that consuming 20 grams of sweet almonds 30 minutes before breakfast, lunch, and dinner daily for 3 months reduces fasting blood glucose and glycated hemoglobin (HbA1c) by 6 mg/dL and 0.4%, respectively, and improves measures of insulin resistance when compared with a control group. For every 4 patients consuming sweet almonds, one additional patient experienced normalization of HbA1c. Body weight, body mass index (BMI), total cholesterol, and low-density lipoprotein (LDL) cholesterol were also improved with sweet almond over control (111389).
• Irritable bowel syndrome (IBS). It is unclear if oral sweet almond flour is beneficial in patients with IBS. Details: Preliminary clinical research in patients with diarrhea-predominant IBS shows that taking sweet almond flour 40 grams orally daily for 20 days does not improve IBS symptom scores when compared with a wheat flour placebo. In fact, those taking sweet almond flour experienced an increase in severity of pain and the number of bowel movements (101785).
• Obesity. It is unclear if oral sweet almond is beneficial in patients with obesity. Details: A moderate-sized clinical study in adults with overweight and obesity shows that consuming 30-50 grams of sweet almonds does not reduce self-reported appetite ratings or subsequent short-term energy intake despite favorable changes in appetite-regulating hormones when compared with a carbohydrate-rich snack as a control (111388). Other preliminary clinical research in adults with overweight or obesity shows that following a calorie-restricted diet with almonds as 15% of total daily energy for 12 weeks increases fat loss by 2.4-fold, but does not affect total weight loss, when compared with a nut-free, calorie-restricted diet (99937). Another preliminary clinical study in mainly overweight individuals shows that consuming sweet almonds 56 grams daily for 4 weeks in addition to the regular diet reduces levels of total and low-density lipoprotein (LDL) cholesterol by approximately 5% when compared with eating isocaloric cookies. However, there was no effect on body weight, body composition, glycemic control, or blood pressure (101790).
• Psoriasis. Although there has been interest in using topical sweet almond oil for psoriasis, there is insufficient reliable information about the clinical effects of sweet almond for this purpose.
• Radiation dermatitis. It is unclear if topical sweet almond ointment is beneficial in patients with radiation dermatitis. Details: Preliminary clinical research in females receiving radiation therapy for breast cancer shows that topical use of a sweet almond ointment once before each treatment and once a few hours after each treatment does not prevent radiation dermatitis when compared with chamomile extract cream (76740).
• Stretch marks (striae gravidarum). It is unclear if topical sweet almond oil is beneficial in patients with stretch marks. Details: Preliminary clinical research in nulliparous patients shows that topical application of sweet almond oil twice daily, starting at gestational week 16 and continued until delivery, does not reduce the size or number of stretch marks when compared with control. However, using the sweet almond oil modestly reduced itching scores (97322). More evidence is needed to rate sweet almond for these uses.

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LIKELY SAFE ...when olive fruit is used orally and appropriately in amounts commonly found in foods.

POSSIBLY SAFE ...when olive leaf extract is used orally and appropriately. Olive leaf extract providing 51-100 mg oleuropein daily has been used with apparent safety for 6-8 weeks (92245,92247,101860). There is insufficient reliable information available about the safety of olive fruit extract when used in amounts greater than those found in foods.

PREGNANCY AND LACTATION:
Insufficient reliable information available; stick with amounts commonly found in foods.

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LIKELY SAFE ...when used in amounts commonly found in foods. Sweet almond is commonly eaten as a food (99937,99938,99939,99941). There is insufficient reliable information available about the safety of sweet almond when used orally or topically in medicinal amounts.

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

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General ...Orally, olive fruit is well tolerated when used in typical food amounts. Olive leaf extract seems to be well tolerated.
Most Common Adverse Effects:
Orally: Headache and stomach discomfort.

Dermatologic ...Orally, one patient in one clinical trial reported bad skin and acne after using olive leaf extract (101860).

Gastrointestinal ...Orally, three patients in one clinical trial reported stomach ache after using olive leaf extract (101860).

Neurologic/CNS ...Orally, three patients in one clinical trial reported headache after using olive leaf extract (101860).

Psychiatric ...In one case report, a 67-year-old female experienced irritability, anger, a lack of control, and feelings of sadness and negativity after consuming a multi-ingredient product containing olive leaf extract 5 grams, horseradish root, and eyebright daily for 38 days. All psychiatric symptoms disappeared within days of stopping the combined product. It is hypothesized that the hydroxytyrosol component of olive leaf extract contributed to these symptoms due to its chemical similarity to dopamine; however, it is not clear if these symptoms were due to the olive leaf extract or to the other ingredients (96245).

Pulmonary/Respiratory ...Olive tree pollen can cause seasonal respiratory allergy (1543).

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General ...Orally, when consumed as food, sweet almond is well tolerated. Orally and topically, when used as medicine, adverse effects from sweet almond seem to be rare; however, a thorough safety evaluation has not been conducted.
Most Common Adverse Effects:
Orally: Allergic reactions.
Topically: Dermatitis, itching.

Dermatologic ...Topically, itching, dermatitis, and worsening eczema have been reported in a clinical trial (101788).

Immunologic ...Tree nuts, which include almonds, can cause allergic reactions in sensitive individuals. Due to the prevalence of this allergy in the general population, tree nuts are classified as a major food allergen in the United States (105410).

Neurologic/CNS ...Orally, adverse effects to sweet almond extract in syrup have included increased sleep (101783).

Other ...Orally, adverse effects to sweet almond extract in syrup have included increased appetite (101783).

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