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CholestOff®
CholestOff®

Frequently Asked Questions
Q. What are plant sterol and stanols and how do they work to lower cholesterol?
Q. How is CholestOff different from other plant sterol/stanol products?
Q. Why does CholestOff need to be taken before a meal?
Q. What happens if I take Cholest off with meals? It is hard to remember to take them 15-30 minutes before meals.
Q. Can it be crushed/cut in half?
Q. If I take CholestOff 30 minutes before breakfast, how long should I wait before taking it again before lunch?
Q. How is CholestOff different from statins, and should I be concerned about my liver?
Q. Is it safe to consume CholestOff while taking cholesterol-lowering medication?
Q. What are the side effects associated with CholestOff?
Q. Does CholestOff lower LDL & HDL cholesterol?
Q. Can you provide me with references to the clinical studies that support CholestOff’s claim that it can "lower LDL cholesterol up to 24%"?
Q. I see calcium listed in the ingredients, how much is in each tablet?
Q. What are plant sterol and stanols and how do they work to lower cholesterol?
A. Phytosterols and phytostanols are found naturally in plants. Because their molecular structure is similar to that of cholesterol they decrease absorption of cholesterol, both from foods and from reabsorption of cholesterol made in the liver and secreted into the intestines.

Sterols and stanols are recommended as part of the NIH’s TLC (Therapeutic Lifestyle Changes) Diet. The TLC diet recommends:

  • Limiting the amount of saturated fat and cholesterol you eat.
  • Eating only enough calories to achieve or maintain a healthy weight.
  • Increasing the soluble fiber in your diet. For example, oatmeal, kidney beans, and apples are good sources of soluble fiber.
  • Adding cholesterol-lowering food, such as margarines that contain plant sterol or stanol esters that lower cholesterol for some people.
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Q. How is CholestOff different from other plant sterol/stanol products?
A. Reducol, the proprietary brand of of phytosterols and phytostanols used in CholestOff, is derived from tall oil extracted from pine trees. Other manufacturers may use soy bean oil.
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Q. Why does CholestOff need to be taken before a meal?
A. Because CholestOff blocks the absorption of the cholesterol that you get from food, it is important that you consume CholestOff 15 to 30 minutes before a meal for optimal effectiveness.
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Q. What happens if I take Cholest off with meals? It is hard to remember to take them 15-30 minutes before meals.
A. It is ok to take CholestOff with meals. You will, however, achieve optimal cholesterol lowering benefits if CholestOff is taken 15-30 minutes before a meal.
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Q. Can it be crushed/cut in half?
A. Yes, CholestOff can be crushed or cut in half for easier swallowing. We do recommend that you still take 2 tablets before your meals – even if you need to cut them.
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Q. If I take CholestOff 30 minutes before breakfast, how long should I wait before taking it again before lunch?
A. There is no time that you need to wait between taking CholestOff. The key is to try to take CholestOff 15-30 minutes before consuming your next meal for optimal cholesterol-lowering benefits.
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Q. How is CholestOff different from statins, and should I be concerned about my liver?
A. Your body gets cholesterol in two ways – from foods and from synthesis in the liver. The class of drugs referred to as 'statins' work by blocking cholesterol synthesis in the liver. CholestOff is a dietary supplement and works by blocking cholesterol absorption from food, without the risk of serious side effects.
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Q. Is it safe to consume CholestOff while taking cholesterol-lowering medication?
A. If you are on a doctor-prescribed drug treatment program, you should consult your physician before making any dietary changes or if you have questions about the simultaneous use of medication and food. Please note that the guidelines established by the National Cholesterol Education Program (NCEP) recommend that people using drug therapy to reduce cholesterol should also follow a heart-healthy lifestyle, including a low-fat, low-cholesterol diet, weight management and exercise. In addition, the NCEP guidelines encourage intake of plant sterols and stanols (as found in CholestOff) as part of a heart-healthy diet. You are already consuming a small amount of stanols and sterols through your daily diet. No adverse side effects were observed in a simultaneous trial of a phytosterol similar to Reducol and a cholesterol-lowering drug. In addition, extensive research by independent experts has shown that phytosterols are safe for general use. However, we always recommend checking with your medical doctor if you are on a doctor-prescribed drug treatment program.
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Q. What are the side effects associated with CholestOff?
A. There are currently no known significant side effects associated with CholestOff.
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Q. Does CholestOff lower LDL & HDL cholesterol?
A. CholestOff only lowers LDL (“bad”) cholesterol and does not affect HDL (“good”) cholesterol
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Q. Can you provide me with references to the clinical studies that support CholestOff’s claim that it can "lower LDL cholesterol up to 24%"?
A.
  1. Beer, Michael. "To Determine the Effect of Increasing Doses of Tall Oil Derived phytosterols (Phytrol) on the Plasma Lipid Levels of Hypercholesterolemic Patients". Novartis Consumer Health & Forbes Meditech. November 14, 2000.
  2. de Graaf J., "Consumption of tall oil-derived phytosterols in a chocolate matrix significantly decreases plasma total and low-density lipoprotein-cholesterol levels". British Journal of Nutrition, Volume 88, Number 5, November 2002, pp. 479-488(10).
  3. Jones, Peter JH. "Cholesterol-lowering efficacy of a sitostanol-containing phytosterol mixture with a prudent diet in hyperlipidemic men1,2,3". American Journal of Clinical Nutrition, Vol. 69, No. 6, 1144-1150, June 1999. (http://intl.ajcn.org/cgi/content/abstract/69/6/1144.)
  4. Jones, P.J.."Plant sterols are efficacious in lowering plasma LDL and non-HDL cholesterol in hypercholesterolemic type 2 diabetic and nondiabetic persons1,2,3,4". American Journal of Clinical Nutrition, Vol. 81, No. 6, 1351-1358, June 2005. (http://www.ajcn.org/cgi/content/abstract/81/6/1351)
  5. Yoshida. "Additive effect of plant sterols and glucomannan in lowering low-density lipoprotein cholesterol in individuals with and without type 2 diabetes". Forbes Medi-Tech.
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Q. I see calcium listed in the ingredients, how much is in each tablet?
A. There is 38.5 mg. of Calcium per tablet
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CholestOff®
CholestOff®

Frequently Asked Questions
Q. What is CholestOff® Complete?
Q. How does CholestOff® Complete differ from other products intended to lower cholesterol?
Q. Can I get CholestOff® Complete ingredients from food?
Q. How much CholestOff® Complete should I take?
Q. What time of day should I take CholestOff® Complete?
Q. Will CholestOff® Complete work if I have only mildly elevated cholesterol?
Q. Where can I purchase CholestOff® Complete?
Q. Can too much CholestOff® Complete have adverse effects?
Q. Is there a minimum age for CholestOff® Complete users?
Q. How long has CholestOff® Complete been on the market in the U.S.?
Q. Is CholestOff® Complete regulated by the Food and Drug Administration?
Q. What are the sources of the active ingredients in CholestOff® Complete?
Q. Are the trees that are the source of phytosterols/stanols genetically modified organisms (GMOs)?
Q. Are the trees “Organic?”
Q. Is there anyone who should not take CholestOff® Complete?
Q. Is there anyone else who should not take CholestOff® Complete?
Q. What is CholestOff® Complete?
A. Nature Made CholestOff® Complete is a dietary supplement containing pantethine (a molecule related to vitamin B5) in combination with a class pf molecules referred to as phytosterols/stanols (phyto meaning plant-derived). Phytosterols/stanols block some of the absorption of cholesterol from the diet without themselves being absorbed.
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Q. How does CholestOff® Complete differ from other products intended to lower cholesterol?
A. The prescription drugs commonly referred to as “statin” drugs (Mevacor, Lipitor, others) taken in doses of 10 to 100 mg block a specific enzyme involved in cholesterol synthesis. Thus, these also influence “genetic” cholesterol, but via a different mechanism from pantethine. Phytosterols function by partially blocking the absorption of cholesterol from the diet. Cholestyramine and soluble fiber product have a similar absorption reducing function. Naicin in gram amounts lowers cholesterol and triglycerides and increases HDL-cholesterol by mechanisms that are not well understood. CholestOff® Complete is a combination of pantethine and plant sterols/stanols. As such, it affects lipids by two separate and distinct mechanisms.
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Q. Can I get CholestOff® Complete ingredients from food?
A. No. Pantethine can be made in the body from vitamin B5, but the amount of vitamin in the diet is about 5 milligrams per day, while the amount of pantethine in CholestOff® Complete is 300 milligrams/day.

Phytosterols/stanols are found in a variety of plant foods but in such small amounts that it would take entirely unrealistic amounts of these foods to deliver a useful amount. Total dietary intake of food phytosterols/stanols is on the order of 150 to 450 mg/day, while the amount in CholestOff® Complete is 1800 mg/day. The FDA requires that a food or dietary supplement deliver at least 800 mg/day divided over two servings to qualify for a label health claim of lowering cholesterol and reducing the risk of heart disease.

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Q. How much CholestOff® Complete should I take?
A. Nature Made® recommends CholestOff® Complete at two caplets twice daily (total of four/day).
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Q. What time of day should I take CholestOff® Complete?
A. Take it with meals, two caplets per meal, twice a day.
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Q. Will CholestOff® Complete work if I have only mildly elevated cholesterol?
A. Clinical trials have shown that plant sterols and stanols such as those in CholestOff ®Complete will lower blood cholesterol concentrations in people with mildly elevated cholesterol. The percentage changes are roughly the same, so that a person starting at 250 mg/dL and a person starting at 200 mg/dL may both see about a 10% decrease.
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Q. Where can I purchase CholestOff® Complete?
A. Nature Made® products are available in the vitamin/mineral aisle of food, drug and club stores nationwide. Consumers can visit www.naturemade.com to find a retailer near them.
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Q. Can too much CholestOff® Complete have adverse effects?
A. The ingredients in CholestOff® Complete are safe when used as recommended, which is four caplets per day (two servings of two caplets). The pantethine ingredient is at 300 mg/day. Many of the published studies made no mention of side effects at intakes as high as 1200 mg/day. A few reported some instances of nausea, diarrhea, heartburn and skin itchiness. There will be an increase of the concentration of vitamin B5 in the blood. Urinary vitamin B5 excretion increases to compensate. There are no reports of adverse effects in humans from high doses of vitamin B5. For the phytosterols/stanols ingredient, numerous clinical trials have found phytosterol/stanol products to be safe – with similar incidence and type of side effects being reported for product and placebo. There are occasional reports of nausea, indigestion, diarrhea and constipation.
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Q. Is there a minimum age for CholestOff® Complete users?
A. Children should not take CholestOff® Complete as it is designed for adults, and its safety has not been evaluated in children. There is no evidence that it would be harmful, but it would be best to be cautious in situations such as these.
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Q. How long has CholestOff® Complete been on the market in the U.S.?
A. CholestOff® Complete was first marketed in the summer of 2007.
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Q. Is CholestOff® Complete regulated by the Food and Drug Administration?
A. CholestOff® Complete is regulated by the Food and Drug Administration and various state regulatory agencies as a food and a dietary supplement. This includes special requirements for both the manufacturing and labeling of the product.
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Q. What are the sources of the active ingredients in CholestOff® Complete?
A. The pantethine in the product is a synthesized molecule. Nature Made uses Pantesin®, a branded pantethine product from Daiichi Pharmaceutical Co., as the ingredient in CholestOff® Complete. The Pantesin® trademark is displayed on the carton and bottle label.

Nature Made uses Reducol®, a branded phytosterols/stanols product from Forbes Medi-Tech, Inc., as the ingredient in CholestOff® Complete. The Reducol® trademark is displayed on the carton and bottle label. The phytosterols/stanols in Reducol® are extracted from coniferous trees.

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Q. Are the trees that are the source of phytosterols/stanols genetically modified organisms (GMOs)?
A. No. Other suppliers of phytosterols/stanols may use soy beans as the source material for their product, in which case there is a high likelihood of being derived from a GMO, as most soy beans grown in the U.S. are genetically modified. While there are no known health risks associated with federal government approved GMOs, consumers who ask this question about the product can be told that it is extracted from a non-genetically modified source [www.reducol.com].
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Q. Are the trees “Organic?”
A. While trees are obviously a natural source, the supplier has not applied for an “Organic” certification from the U.S. Department of Agriculture. The ingredient should not be referred to as “Organic.”
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Q. Is there anyone who should not take CholestOff® Complete?
A. From the box label: “CAUTION: Not for use by pregnant or lactating women or children. Check with your physician before beginning use of CholestOff if you are currently using medications to lower your cholesterol.”
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Q. Is there anyone else who should not take CholestOff® Complete?
A. Based on the mild-to-nonexistent side effects of the ingredients used in CholestOff® Complete, there are no other restrictions. As with all dietary supplements, anyone under a physician’s care for a specific illness or condition, or taking a prescription medication, should inform their physician of all dietary supplement products they are taking.
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†These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure,or prevent any disease.