Benecol Olive Spread [Discontinued] by McNeil Nutritionals

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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LIKELY EFFECTIVE

• Hypercholesterolemia. Taking sitostanol orally is likely effective for reducing total and low-density lipoprotein (LDL) cholesterol levels in adults with hypercholesterolemia (1886,3888,5336,5429,5430,5431,5432,5433,5434,5435)(5437,5438,5439,5441,7103,112081). Sitostanol also seems to be effective for reducing cholesterol levels in healthy children (7193,7194). However, treating children is not recommended unless LDL levels are greater than 190 mg/dL or greater that 160 mg/dL in the presence of other coronary risk factors. Sitostanol is usually taken as a component of a sitostanol-enriched food such as margarine. It is effective in about 88% of patients when used alone or in combination with a low-fat diet or HMG-CoA reductase inhibitor ("statin") for reducing total and LDL cholesterol (3888,5431,5433,5435,5437,5814,7195). Taking sitostanol 1.8-4 grams daily can reduce total cholesterol levels by 6% to 13% and LDL cholesterol levels by 6% to 20% (5431,5432,5433,5439,5441,90731). When added to a statin such as pravastatin (Pravachol) or simvastatin (Zocor), sitostanol reduces total cholesterol by an additional 3% to 11% and LDL cholesterol by another 7% to 16% (5431,5433). Analyses of clinical research show that sitostanol reduces cholesterol levels as effectively as or better than plant sterols (90730,90744). Most research shows that peak cholesterol lowering effects of sitostanol occur at about 2-3 grams daily, with higher doses not offering any additional benefit (5814,6185,7195,14298,14814,90748). However, some clinical research shows that taking sitostanol-rich plant stanols 3-9 grams daily induces a dose-dependent decrease in LDL cholesterol in patients not taking cholesterol-lowering medication (90725). But there is some concern that such high doses of sitostanol might not be safe long-term (90729). Treatment with sitostanol for 2-3 weeks is usually necessary before cholesterol levels decrease significantly. If sitostanol is discontinued, cholesterol levels tend to rise within 2-3 weeks (7105).

POSSIBLY EFFECTIVE

• Familial hypercholesterolemia. Taking sitostanol orally in three divided doses daily reduces total cholesterol by 11% to 14% and low-density lipoprotein (LDL) cholesterol by 15% to 33% in children with familial hypercholesterolemia (3888,3889,5438). Sitostanol also seems to improve cholesterol levels in adults with familial hypercholesterolemia who are already being treated with statins. Preliminary clinical research shows that taking sitostanol about 2 grams in three divided doses daily for 6 weeks decreases total cholesterol by 14% and LDL cholesterol by 20% compared to baseline in adults with familial hypercholesterolemia who are already taking simvastatin 20-40 mg daily (3888). Sitostanol does not affect high-density lipoprotein (HDL) cholesterol or triglyceride levels in children or adults with familial hypercholesterolemia (3888,5438,90743).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Cancer. A meta-analysis of population research has found that although the highest intake of plant sterols is associated with a reduced risk of cancer when compared with the lowest intake, there is no association between sitostanol and cancer risk based on two available studies (106084).
• Esophageal cancer. 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 sitostanol, measured five years before diagnosis (112082).
• Obesity. In Chinese adults, higher dietary intake of sitostanol is inversely related to the risk of being overweight (112083). More evidence is needed to rate sitostanol for these uses.

(Read more about SITOSTANOL)

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 orally and appropriately in doses up to 9 grams daily. Sitostanol has been safely used in studies lasting up to one year (5336,5429,5430,5431,5432,5433,5434,5435,5436,5437) (5438,5439,5441,5814,90725,90731).

CHILDREN: LIKELY SAFE
when used orally and appropriately, short-term in doses up to 6 grams daily. Sitostanol has been safely used in children in studies lasting for up to 3 months (3888,3889,5438,7193,7194). There is insufficient reliable information available about the safety of long-term use of sitostanol in children.

PREGNANCY AND LACTATION:
Insufficient reliable information is available; avoid using.

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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, sitostanol is well tolerated. Adverse effects have not been reported in clinical trials in adults or children (3888,5336,5429,5430,5431,5432,5433,5434,5435,5436)(5437,5438,5439) (5441,7103,7104,7105,7193,7194) (90725,90731,90750). However, because sitostanol decreases cholesterol absorption in the gut, it might be expected to produce some gastrointestinal symptoms like diarrhea and excess amounts of fat in the stool (steatorrhea).

Gastrointestinal ...Although adverse effects have not been reported, sitostanol decreases cholesterol absorption in the gut, and it might be expected to produce some gastrointestinal symptoms like diarrhea and excess amounts of fat in the stool (steatorrhea).

(Read more about SITOSTANOL)