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This page includes a product evaluation for Nature Made CholestOff |
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| This is in no way an endorsement of Cholestoff | |
| Ingredients | Purpose |
| Plant sterols and stanols (1) |
The FDA, authorized use of labeling health claims about the role of plant sterol or plant stanol esters in reducing the risk of coronary heart disease (CHD) for foods containing these substances. FDA is also requiring, consistent with other health claims to reduce the risk of CHD, that the claim state that plant sterol and plant stanol esters should be consumed as part of a diet low in saturated fat and cholesterol. The International Food Information Council has published an article that provides positive information on the use of plant sterols and stanols summarized as follows: "Foods and beverages supplemented with plant sterols/stanols may reduce cholesterol and are a promising addition to interventions aimed at lowering heart disease risk. Maximum effects are observed at plant sterol/stanol intakes of approximately two to three grams per day. The level of LDL cholesterol reduction ranges between six to 15 percent. A growing body of scientific evidence also suggests other positive health outcomes that include the reduced risk of certain types of cancer." |
| Tricalcium Phosphate |
"Tricalcium phosphate is a compound with formula Ca3(PO4)2. It is also known as calcium orthophosphate, tertiary calcium phosphate, tribasic calcium phosphate, or "bone ash" (calcium phosphate being one of the main combustion products of bone)". Contra indications: It may "cause irritation to the gastrointestinal tract" Wikipedia. |
| Croscarmellose Sodium | "Croscarmellose sodium is a very commonly used FDA approved pharmaceutical additive. Its purpose in most tablets - including dietary supplements - is to assist the tablet in disintegrating in the intestinal tract at the required location. If a tablet disintegrating agent is not included, the tablet could disintegrate too slowly, or in the wrong part of the intestine or not at all, thereby reducing the efficacy of the active ingredients." wikipedia . |
| Hydroxypropyl Methyl cellulose |
Widely used as an emulsifier, bulking agent, stabilizer and thickener in food supplements and medicinal compounds where it functions to delay the release into the digestive tract." Wikipedia |
| Calcium Carbonate | "Calcium Carbonate may be used in the pharmaceutical industry as an inert filler for tablets and other pharmaceuticals." Wikipedia Widely used as an acidity regulator, anti caking agent, emulsifier, stabilizer and for color in foods and food supplements. |
| Silicon Dioxide | "A food additive, primarily as a flow agent in powdered foods, or to absorb water (see the ingredients list for). In all other respects, silicon dioxide is inert and harmless. When silica is ingested orally, it passes unchanged through the gastrointestinal tract, exiting in the feces, leaving no trace behind. Small pieces of silicon dioxide are equally harmless, as long as they are not large enough to mechanically obstruct the GI tract, or jagged enough to lacerate its lining. Silicon dioxide produces no fumes and is insoluble in vivo. It is indigestible, with zero nutritional value and zero toxicity." Wikipedia widely used in foods and food supplements as an anticaking agent in foods and food supplements. http://www.codexalimentarius.net/gsfaonline/additives/details.html?id=284 |
| Magnesium Stearate |
When used as a filling agent in the manufacture of capsules and tablets, such as vitamins, the source of this ingredient is typically beef. However, there is an increasing number of vegetarian options in which the product specifically indicates it contains magnesium stearate from vegetable sources. According to Dr Ron , "it is used in manufacturing to make the machines run faster. Another problem with stearates: concentrated doses of stearic acid suppress the action of T-cells, a key component of the immune system. The article “Molecular basis for the immunosuppressive action of stearic acid on T cells” appeared in the journal Immumology in 1990. |
| Titanium Dioxide (artificial color) | Titanium dioxide has recently been classified by the International Agency for Research on Cancer (IARC) as an IARC Group 2B carcinogen ''possibly carcinogen to humans''. Canadian Centre for Occupational Health and Safety It may be used as a coloring agent in a wide variety of foods and foosd supplements http://www.codexalimentarius.net/gsfaonline/additives/details.html?id=184 |
| Polyetholine Glycol | This medication is used to treat occasional
constipation. It works by holding water in the stool to soften the stool
and increases the number of bowel movements. It is known as an
osmotic-type laxative.
SIDE EFFECTS: Nausea, abdominal cramping, or gas may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Inform your doctor immediately if you have excessive number of bowel movements and persistent diarrhea while using this medication. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.--medicinenet.com |
| Triethyl Citrate |
The major use for Triethyl Citrate, F.C.C. Grade is in dried egg whites as a whipping agent. It has approval as a food additive and for food contact use as well as in flavorings as indicated in the specific sections of the Code of Federal Regulation Vol. 21 noted below.--morflex.com |
| Polysorbate 80 | Polysorbate 80 (commercially also known as Tween® 80, a trademark of Croda International Plc, previously Uniqema/ICI)[1] is a nonionic detergent and emulsifier derived from polyoxylated sorbitol and oleic acid, and is often used in foods." Wikipedia. Also Polysorbate 80 might be an irritant according to the same article. limited to 2.5 % in foods and food supplements. http://www.codexalimentarius.net/gsfaonline/groups/details.html?id= 99 |
| Sodium Citrate | Sodium citrate is chiefly used as a Food_additive, usually for flavor or as a preservative. Sodium citrate is employed as a flavoring agent in certain varieties of club soda. Wikipedia |
The principal ingredients in Nature Made CholestOff are plant sterols and stanols which are phytosterols. They are essential components of plant membranes that resemble the chemical structure of animal cholesterol and carry out similar cellular functions in plants. They are also known to block cholesterol absorption sites in the human intestine thus helping to reduce cholesterol. The FDA, authorized use of labeling health claims about the role of plant sterol or plant stanol esters in reducing the risk of coronary heart disease (CHD) for foods containing these substances. FDA is also requiring, consistent with other health claims to reduce the risk of CHD, that the claim state that plant sterol and plant stanol esters should be consumed as part of a diet low in saturated fat and cholesterol.
The label states: No artificial flavors, no preservatives, no chemical solvents, yeasts, starch, or gluten. It also states that CholestOff is clinically proven which will be discussed later. Other ingredients include: Tricalcium phosphate whi can be an irritant in the gastrointestinal tract. Magnesium Stearate which is used to lubricate the product in order to increase the manufacturing efficiency. While we are in favor of efficiency, we are not sure we want it at the expense of unnesessary dietary intake. Vegans beware, this additive can be derived from red meat, although the industry is attempting to find other sources. Titanium Dioxide is used as a color additive, however it has been identified as a carcinigen by the Canadian Centre for Occupational Health and Safety. Perhaps this is insignificant to non Canadians, however, at least let it be a red flag. Titanium dioxide is also used in a wide array of consumer products. Why do we need a color additive in a food supplement anyway? Does this mean that the product without the whitener would be objectionable? Duh, eliminate it and cut the cost! Here's a good one; Polyethyline Glycol in large doses is a medication known to treat occaisional constipation. As a food supplement additive it may be used as an anticaking or antifoaming agent additive the maximum allowance is 7% by weight according to the GSFA (http://www.codexalimentarius.net/gsfaonline/additives/details.html?id=270 ) .The relatively minute amount in this product would most likely have little effect., see medicinenet.com. Why do we need this? Sodium Citrate is chiefly used as a Food_additive, usually for flavor or as a preservative. Sodium citrate is employed as a flavoring agent in certain varieties of club soda. Wikipedia
Clinical trials:
http://www.ajcn.org/cgi/content/abstract/81/6/1351
Plant sterol consumption significantly reduced (P < 0.05) LDL-cholesterol concentrations from baseline in both nondiabetic and diabetic subjects by 15.1% and 26.8%, respectively. The diabetic subjects had significantly (P < 0.05) lower absolute concentrations of total cholesterol after treatment than did the nondiabetic subjects; however, there was no significant difference in the percentage change from the beginning to the end of the trial. There was also a significant decrease (P < 0.05) in absolute non-HDL-cholesterol concentrations after treatment in both groups.
An investigation by the Electronic Retail Self-Regulation Program (ERSP) was made into the manufacturer of Cholesoff's claims that use of the product can reduce the ldl cholesterol by 24% in 30 days. It also question the claim of 100's of clicical trials. This inviestigation conluded that the manufacturer's claims were not unreasonable. For a full report on the investigation visit http://www.retailing.org/new_site/documents/govaffairs/ERSP_Findings/pharmavite_decision.doc.
Notes:
(1) Plant sterols
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