CholestOff Plus by Nature Made

LIKELY EFFECTIVE

• Familial hypercholesterolemia. Oral plant sterols are beneficial for reducing levels of low-density lipoprotein (LDL) cholesterol when used in combination with a cholesterol-lowering diet in children and adults with familial hypercholesterolemia (FH). Details: A meta-analysis of results from clinical research in children and adults with FH shows that taking plant sterols while following a cholesterol-lowering diet reduces total cholesterol by an additional 12 mg/dL and LDL cholesterol by an additional 23 mg/dL when compared with following a cholesterol-lowering diet alone (90743). Individual clinical trials in adults and children 5 years and up show that consuming margarine spreads or yogurt enriched with plant sterol 1.6-2.3 grams daily for 4-26 weeks, sometimes in combination with statin therapy, reduces total cholesterol by up to 11% and LDL cholesterol by up to 14% in patients with FH (90726,90731,35037,35106). However, most clinical research shows that plant sterols do not reduce triglyceride levels or increase high-density lipoprotein (HDL) cholesterol levels in patients with FH (35037,35106,90743).
• Hypercholesterolemia. Oral plant sterols in doses of 2-3 grams daily are beneficial for reducing levels of low-density lipoprotein (LDL) cholesterol, but not triglycerides, when used in combination with a cholesterol-lowering diet. Details: Clinical research shows that taking plant sterols, alone or in combination with plant stanols, reduces total and LDL cholesterol levels in patients with hypercholesterolemia. Taking plant sterols daily while following a cholesterol-lowering diet reduces total cholesterol by about 3% to 8% and LDL cholesterol by about 5% to 15% when compared with dieting alone (5336,5437,7105,65749,90686,90720,90722,90723,90724,90734)(90741,90748,90752,106093). Plant sterols seem to have the most significant cholesterol-lowering effect in people who naturally produce a high amount of cholesterol (90742). When taken along with statin therapy, plant sterols can lower total cholesterol by about 12-22 mg/dL and LDL cholesterol by about 11-16 mg/dL when compared with statin therapy alone (90728,96272). Predictive modeling suggests that the cholesterol reduction from plant sterols can reduce the risk of cardiovascular disease over time. In English adults with hypercholesterolemia and no cardiovascular disease, replacing regular spreads with plant sterol -enriched spreads over a 20-year period could potentially prevent 69 cardiovascular events per 10,000 males and 40 events per 10,000 females (98449). Plant sterols, usually as esters, with or without plant stanols, 0.2-9 grams daily for up to one year have been used (5336,5437,5814,7105,14298,90686,90720,35034,90722,90723)(90724,90726,90730,90732,90733,90734,90741,90742,90744,90748)(90752,96272). However, the optimal dosage of plant sterols for reducing LDL cholesterol is about 2-3 grams daily taken with meals (5814,90733,90748). At this dosage, plant sterols seem to work as well as plant stanols but less effectively than taking policosanol 5-40 mg daily (14298,90730). When taken as fortified foods, plant sterols appear to be more effective when taken in dairy products than in breads or cereals (35034). No increased benefit is seen at dosages higher than 2-3 grams daily (90744). In post-menopausal females, a meta-analysis of 6 studies shows that plant sterols are most effective for reducing total and LDL cholesterol in patients with obesity, using a daily dose of plant sterols greater than 2 grams, and duration of treatment greater than 8 weeks (112081). Additionally, some clinical research shows that plant sterols might become less effective after about 2-3 months of treatment (90726). Results from most individual clinical studies show that plant sterols do not reduce triglyceride levels in patients with hypercholesterolemia (65749,90720,90732,96272,106093,112081). However, a meta-analysis of results from 12 clinical studies shows that taking plant sterols 0.8-4 grams daily reduces triglyceride levels by 6% in patients with hypercholesterolemia (90732). This suggests that plant sterols might modestly lower triglyceride levels in some patients, but more research in larger patient populations is needed to confirm this finding. There is also some evidence showing that plant sterols prepared as ester derivatives using fish oil rather than sunflower oil, olive oil, or rapeseed oil can moderately lower triglyceride levels when compared with placebo (90739). However, this benefit is likely due to the triglyceride-lowering activity of fish oil rather than plant sterols. Taking plant sterols does not improve levels of high-density lipoprotein (HDL) cholesterol (65749,90728,90732,96272,112081).

POSSIBLY EFFECTIVE

• Coronary heart disease (CHD). The US Food and Drug Administration (FDA) has approved an authorized health claim for dietary plant sterols, when taken in doses of at least 3.4 grams daily as part of a diet low in saturated fat and cholesterol, for reducing the risk of CHD. Details: In 2010, the US FDA authorized a health claim stating that consuming at least 3.4 grams of plant sterols daily, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease (102365). This health claim is based on evidence showing that plant sterols can lower cholesterol levels. However, there is currently no evidence directly linking dietary intake of plant sterols with a reduced risk for developing CHD.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Cancer. It is unclear if dietary plant sterols are beneficial for cancer prevention. Details: A meta-analysis of population research has found that the highest intake of plant sterols is associated with a 37% reduced risk of cancer when compared with the lowest intake (106084).
• Colorectal cancer. It is unclear if dietary plant sterols are beneficial for colorectal cancer prevention. Details: Population research has found that dietary intake of specific plant sterols, including campesterol, stigmasterol, or beta-sitosterol, is not associated with risk of developing colon cancer. Dietary intake of plant sterols also does not affect the risk of rectal cancer in females; however, in males, higher dietary intake of the plant sterols campesterol or stigmasterol is associated with an INCREASED risk of rectal cancer (34993).
• Esophageal cancer. It is unclear if dietary plant sterols influence the outcome of esophageal cancer. Details: In Chinese people with esophageal squamous cell carcinoma, the mortality rate does not seem to differ between those with the lowest versus the highest intake of dietary plant sterols, measured five years before diagnosis (112082).
• Gastric cancer. It is unclear if dietary plant sterols are beneficial for gastric cancer prevention. Details: Population research has found that consuming at least 82.5 mg of plant sterols daily as part of the diet is associated with moderately lower odds of developing gastric cancer when compared to those who consume less than 45.5 mg daily (34984).
• Impaired glucose tolerance (prediabetes). Although there is interest in using oral plant sterols for prediabetes, there is insufficient reliable information about the clinical effects of plant sterols for this condition.
• Metabolic syndrome. It is unclear if oral plant sterols are beneficial for metabolic syndrome; the available research is conflicting. Details: One clinical study shows that taking yogurt mini-drinks providing plant sterols 2 grams twice daily for 8 weeks reduces total cholesterol by about 16%, low-density lipoprotein (LDL) cholesterol by about 20%, and triglyceride levels by about 19% when compared with control yogurt drinks without plant sterols (90749). However, results from a much smaller study in patients with metabolic syndrome shows that taking plant sterols 2 grams daily for 8 weeks in breakfast cereal and margarine does not improve plasma lipids or other cardiovascular markers when compared with placebo foods (90745). Reasons for the discrepancy are not clear but might relate to the dose or formulation of plant sterol, or the lipid levels of the patients at baseline.
• Myocardial infarction (MI). It is unclear if dietary plant sterols are beneficial for MI prevention. Details: Population research has found that consuming approximately 340 mg of plant sterols daily is associated with a 29% lower risk of first myocardial infarction in males when compared with those who consume about 150 mg daily. However, dietary plant sterol intake is not associated with a reduced risk of first myocardial infarction in females (90740).
• Obesity. It is unclear if oral plant sterols are beneficial for obesity. Details: In Chinese adults, higher dietary intakes of beta-sitosterol, stigmasterol, and total plant sterols are inversely related to the risk of being overweight. The risk of central obesity is linked to stigmasterol intake in females, and to beta-sitosterol intake in males (112083). Preliminary clinical research in obese individuals shows that consuming rice bran snack bars fortified with a mixture of plant sterols and stanols 1.8 grams daily for 8 weeks while following a reduced calorie diet does not increase weight loss, reduce low-density lipoprotein (LDL) cholesterol, or improve blood glucose control when compared to dieting and consuming unfortified rice bran snack bars. However, the plant sterol-enriched rice bran snacks appear to decrease total cholesterol by about 10% more than unfortified rice bran snacks (90738). More evidence is needed to rate plant sterols for these uses.

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LIKELY SAFE ...when used orally and appropriately. Plant sterols have been safely used in studies lasting up to one year (35022,35037,90724,90726,90730,90732,90733,90734,90739,90742). Due to the unknown safety of plant sterol oxidation products, and the known production of these oxidation products during the heating of foods (106092), there is insufficient reliable information available about the safety of heat-treated foods containing added plant sterols.

CHILDREN: LIKELY SAFE
when used orally and appropriately. Plant sterols have been safely used in children in studies lasting for up to 6 months (35037,90722,90723,90726,90731,35106). PREGNANCY AND LACTATION: Insufficient reliable information available; avoid using.

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General ...Orally, plant sterols are generally well tolerated.

Dermatologic ...Acute dermatitis has been reported in a case report of a 51-year-old female who used a pharmacy-brand plant sterol supplement to lower cholesterol levels. The rash was widespread with lesions on the hands and feet and a red and swollen face. The patient was treated orally with prednisolone and topically with emollients for 2 weeks (90737). It is not entirely clear if this adverse effect was due to the plant sterol supplement or another contributing factor.

Endocrine ...Peripheral precocious puberty has been described in a 20-month-old boy who ingested about 15 grams daily of a chicken essence product containing the plant sterol avenasterol, also known as clerosterol or chondrillasterol. Signs and symptoms included elevated estradiol and testosterone levels, acne, hairiness, increased penis size, hoarse voice, and increased growth rate. These effects were reversed when the product was stopped (112084).

Gastrointestinal ...Abdominal discomfort has occurred in one child in a clinical trial of oral plant sterols (35106). Because plant sterols decrease cholesterol absorption in the gut, there is concern that they might produce some gastrointestinal symptoms like diarrhea and excess amounts of fat in the stool (steatorrhea), although these adverse effects have not been reported in clinical research.

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