A study published in the Journal of the Academy of Nutrition and Dietetics has demonstrated the effectiveness of a sterol/stanol ester softgel capsule for lowering low-density lipoprotein (LDL) cholesterol in individuals with high cholesterol levels.

Plant sterols and stanols occur naturally in plant-based foods and have been shown to decrease cholesterol levels by reducing absorption in the intestinal tract. 
 
Pharmavite LLC, makers of Nature Made brand dietary supplements, provided the sterol/stanol esters used in this study in the form of its CholestOff softgel dietary supplement.
 
The randomized, double-blind, placebo-controlled study involved 30 non-smoking, men and women. In a crossover fashion, all subjects received a sterol/stanol softgel for 6 weeks and a placebo for 6 weeks with the order of treatments randomly assigned.Study participants also 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 (NIH) to reduce cholesterol levels to help 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 that contained only soybean oil and medium-chain triglycerides for six weeks each. Throughout the study, subjects were restricted from consuming any dietary supplements as well as plant sterol and stanol fortified foods.
 
After taking the sterol/stanol softgels for six weeks, reductions were significant versus the placebo period (P < 0.01) for LDL cholesterol (-4.3%), non-HDL cholesterol (-4.1%) and total cholesterol (-3.5%).
 
These study findings demonstrate the effectiveness of plant sterols and stanols from CholestOff softgel capsules for lowering cholesterol levels as part of the NCEP TLC diet in subjects with high cholesterol. The softgel supplement 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 positive changes in cholesterol levels in individuals with high cholesterol have been observed in previous studies. Many individuals consuming a typical Western Diet consume as little as 200 milligrams of plant sterols and stanols each day, a level unlikely to change blood cholesterol levels.