Beyond Fortified Foods: New Clinical Trial Affirms Softgel Sterol/Stanol Supplement Effective for Lowering Cholesterol Levels

Jan 08, 2013, 08:00 ET from Pharmavite LLC

As Part of the National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Changes (TLC) diet, Sterol/Stanol Softgels Offer a Convenient Way to Improve Cholesterol Levels

NORTHRIDGE, Calif., Jan. 8, 2013 /PRNewswire-USNewswire/ -- The following is being released by Pharmavite LLC:

A research study published this month in the journal Nutrition demonstrates the effectiveness of a sterol/stanol ester-based softgel capsule for decreasing LDL cholesterol in individuals with high cholesterol levels. Few clinical trials have investigated the effect of plant sterols and stanols on cholesterol levels when administered in supplement form; most studies have examined the effect of plant sterols and stanols from fortified commercially available food sources such as margarine-type spreads, yogurt, and orange juice.  Nature Made® provided the sterol/stanol esters in the form of its CholestOff® softgel dietary supplement.

Plant sterols and stanols occur naturally in plant-based foods and their physical structure resembles cholesterol in the body. Sterols and stanols have been shown to reduce cholesterol levels by reducing absorption in the intestinal tract. Throughout this study, all subjects followed a heart healthy diet (National Cholesterol Education Program TLC Diet). Subjects were divided into two groups. One group received a sterol/stanol softgel for 6 weeks while the other took a placebo. After the six weeks, the groups switched treatments while maintaining the same TLC diet.  After taking the sterol/stanol softgels daily for six weeks, cholesterol changes, in the per protocol group,were statistically significant (P < 0.05) for LDL cholesterol (also known as bad cholesterol) (-9.2%), non-HDL cholesterol (-9.0%), total cholesterol (-7.4%), total cholesterol/HDL-C ratio (-5.4%), and triglycerides (-9.1%).

"This study is a significant contribution to our overall understanding of dietary supplements' role in the reduction of blood cholesterol levels," said Dr. Kevin Maki, lead author from Biofortis Clinical Research. "Our results show that a softgel capsule can be an effective and convenient way to deliver a therapeutic dose of sterol/stanol esters in a non-food matrix."

The softgel supplement used in this study provided 1.8 grams of esterified plant sterols and stanols (in two softgels taken twice daily) with meals. This dosage is within the range for which effective reduction of LDL cholesterol levels in individuals with high cholesterol have been observed in previous scientific studies. A typical Western diet includes roughly 150 to 400 milligrams of plant sterols and stanols, a level unlikely to change blood cholesterol levels. 

"Nature Made developed the CholestOff dietary supplement to ensure that the dose provided was consistent with the scientific literature that showed an effective reduction in blood cholesterol levels," said Dr. James Brooks, Vice President, Science and Technology, Pharmavite, LLC and study co-author. "Previously, a study was published showing that the tablet form of CholestOff lowered cholesterol levels significantly so this new study of our softgels adds to the assurance consumers can have using this product."

The randomized, placebo-controlled, crossover trial lasted 17 weeks and involved 28 predominantly non-Hispanic, non-smoking overweight men and women. Study participants followed the National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Changes (TLC) diet throughout the duration of the study, starting five weeks before the plant sterol/stanol capsules and placebo capsules were administered. The TLC diet is a low saturated fat, low cholesterol diet developed by the National Institutes of Health to lower cholesterol levels in an aim to reduce heart disease risk. Five weeks after starting the TLC diet, subjects were randomly assigned, in a double-blinded manner, to receive either Cholestoff softgels or a placebo softgel for six weeks each. After six weeks, study subjects crossed over to the opposite product for another six weeks. Participants were restricted from consuming dietary supplements and plant sterol and stanol fortified foods during the study and four weeks leading up to the study.

The study findings provide additional science on the effectiveness of a supplement delivery/form of plant sterols and stanols from CholestOff softgel capsules for lowering blood cholesterol levels as part of the NCEP TLC diet in subjects with high cholesterol. For some individuals, the capsules may be a more convenient and appealing option for individuals managing their cholesterol that could increase compliance during long-term use. Long term compliance is especially important when considering the potential usefulness of a product for lowering cholesterol. For more information about Nature Made® CholestOff, please visit

About Pharmavite LLC:  
For more than 40 years, Pharmavite LLC has earned and maintained the trust of healthcare professionals, consumers, and retailers by manufacturing high-quality vitamins, minerals and other dietary supplements, and all-natural foods under its Nature Made®, Voots®Veggie Fruit Tarts and SOYJOY® brand names. Based in Northridge, California, Pharmavite LLC operates as a subsidiary of Otsuka Pharmaceutical Co., Ltd. For more information, please visit

SOURCE Pharmavite LLC