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Release date: 2/15/2012

Northridge, CALIF (February 15, 2012) – A study published in the November 2011 International Journal of Food Sciences and Nutrition demonstrated nearly 5 percent reduction in “bad” low-density lipoprotein (LDL) cholesterol when Cholestoff was added to the National Cholesterol Education Program (NCEP) therapeutic lifestyle changes (TLC) diet. Cholestoff is a dietary supplement containing 1.8 grams of free (non-esterfied) phytosterols.

‘The results of this study are both statistically significant and clinically relevant,’ said study co-author, Kevin C. Maki, Ph.D. ‘The study demonstrates that this supplement containing free (non-esterfied) phytosterols, when added to the NCEP’s TLC diet, significantly reduced the levels of both total and LDL (bad) cholesterol among the study participants, all of whom had elevated cholesterol initially. The FDA has concluded ‘[t]he scientific evidence establishes that including phytosterols in the diet helps to lower blood total and LDL cholesterol levels’ and this study demonstrates that this dietary supplement formulation of free (non-esterified) phytosterols perform this function.’

Most clinical trials examining the effects of phytosterols on cholesterol have used food forms including margarine-type spreads, orange juice, yogurt and yogurt-based drinks. In contrast, few have investigated the effects of phytosterols as supplements. The US Food and Drug Administration concluded in 2010 that the formulation of phytosterols in dietary supplements can play an important role in cholesterol reduction in addition to a healthy diet and exercise.

The study enrolled 32 men and women, aged 21 to 79 years, in good general health but with fasting levels of LDL cholesterol ranging from 131 to 220 mg/dl. The supplement, Cholestoff, provided 1.8 grams daily of free plant sterols and stanols via four tablets daily (two tablets with each of two meals).

For this double-blinded crossover study, participants first followed the TLC diet and used a placebo for five weeks. Then investigators randomized the patients to six weeks of the TLC diet with either a free-phytosterols dietary supplement or the same number of matching placebo tablets followed by six weeks in which the participants switched to the opposite treatment while remaining on the TLC diet. The investigators measured the effects of the treatments by comparing the cholesterol levels at the study start to the average of the levels measured at the last two weeks of each treatment period.

This double-blind crossover study shows that consuming a supplement containing 1.8 grams daily of free plant sterols and stanols, a naturally occurring plant-based ingredient, while following the NCEP’s TLC diet significantly reduced the LDL-C levels of participants by 4.9 percent (P=0.002) after six weeks of treatment, compared to participants consuming the NCEP diet with a placebo. There were no statistically significant or clinically relevant changes in the patients’ vital signs, body weight or non-lipid clinical laboratory values.

‘This study adds to the body of knowledge that supports the use of this dietary supplement of phytosterols in the appropriate daily dosages as an effective approach to lower LDL cholesterol in conjunction with a healthy diet and exercise program,’ said Belinda H. Jenks, Ph.D., Director of Scientific Affairs & Nutrition Education at Pharmavite LLC., and coauthor of the study. ‘These study results could be useful to healthcare providers and their patients considering options to reduce bad cholesterol,’ continued Jenks ‘especially as this free-phytosterols supplement, Cholestoff, can easily be added to a cholesterol-lowering regimen without negatively impacting a person’s diet or caloric intake.’

The study was sponsored by Pharmavite LLC.

About Pharmavite
For 40 years, Pharmavite has earned and maintained the trust of healthcare professionals, consumers, and retailers by manufacturing high-quality vitamins, minerals, herbs and other dietary supplements that are safe, effective and science-based. Nature Made® is the number one selling dietary supplement brand in the food, drug, club and mass channels. Nature Made has been and continues to be committed to third-party research in order to advance the supplement industry as a whole and to provide quality and effective dietary supplements. The dietary supplement industry is regulated by the U.S. Food and Drug Administration and the Federal Trade Commission, as well as by government agencies in each of the 50 states.

About NCEP
Current NCEP Guidelines Recommend Phytosterols

The current NCEP guidelines recommend adding 2 grams daily of plant sterols or stanols, also known as phytosterols, to its therapeutic lifestyle changes (TLC) diet for people who do not achieve their LDL cholesterol treatment targets with diet alone. Phytosterols have a structure similar to cholesterol and, therefore, compete with cholesterol for certain body processes, resulting less cholesterol absorption in the intestine and its removal from the bloodstream.

About TLC Diet

The TLC Diet’s Guidelines outline a diet that contains:

  • Less than 7% of the day’s total calories from saturated fat
  • 25-30% of the days total calories from fat
  • Less than 200 milligrams of dietary cholesterol per day
  • Limit sodium intake to 2400 milligrams per day

About CholestOff
CholestOff contains free plant sterols and stanols, and the recommended dose is two tablets taken twice daily at meals. Each CholestOff tablet supplies 450 milligrams (mg) of plant sterols and stanols and the recommended daily intake would provide 1,800 mg (1.8 grams). CholestOff provides the extra 1800mg of plant sterols and stanols that most Americans need to meet the recommendations of the National Cholesterol Education Program to reduce LDL-C levels. For more information about CholestOff visit the Nature Made web site at

About Cholesterol and Hypercholesterolemia
Cholesterol is a waxy, fat-like substance that is part of every cell of the body. The body uses cholesterol to create cell membranes, certain hormones and compounds that help in fat digestion. Cholesterol travels in the blood in small particles called lipoproteins and includes both low- and high-density lipoproteins (LDL and HDL). High LDL levels can contribute to the build-up of plaque within the arteries, which may decrease or block the flow of blood and damage the tissues the blood supports. For example, the buildup of cholesterol in the heart’s arteries increases the risk of developing heart disease or heart attacks.

Hypercholesterolemia is a condition characterized by very high levels of cholesterol in the blood. Millions of American adults have elevated cholesterol levels.

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