Assessing the Claims of Dietary Supplements

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Maintaining a strict gluten-free diet, currently the only treatment available for patients with celiac disease, can be difficult and burdensome. It should come as no surprise, then, that patients are eager to investigate alternative treatments that might provide symptom relief, or ease the need for rigid adherence to a gluten-free diet. Enter the dietary supplement market and a number of products called “glutenases” targeting this particular need.

Researchers from the Celiac Disease Center at Columbia University set out to identify products with either overt or implied claims to aid in the digestion of gluten and to evaluate their ingredients, claims, and disclaimers. A thorough Google search was conducted to identify enzyme supplements commercially available in the United States that claimed to degrade gluten. This search ultimately identified 14 products, many of which had names like Gluten Cutter, GlutenEase, and Gluten Defense, implying relief for the celiac disease and non-celiac gluten/wheat sensitive communities.

One of the effects of gluten is that it leaves large molecules, up to 33 amino acids in length, intact at the time of leaving the stomach and entering the small intestine. Molecules over nine amino acids long are particularly prone to binding to HLA-DQ2 and HLA-DQ8 antigen-presenting T-cells, the types most commonly present in individuals with celiac disease. The resulting theory is that degrading molecules to fewer than nine amino acids in length will minimize damage as the gluten passes through the small intestine. While there is promising research and development being conducted regarding enzymes (called ‘proteases’) to break up these large molecules, scientists have yet to develop a commercially available product for this purpose.

Instead, the dietary supplement industry has risen to the demand. Unlike with food, pharmaceutical, and cosmetic products, the FDA has little to no authority over the dietary supplement industry; in fact, close regulation of the industry is specifically prevented. This gives the manufacturers of dietary supplements considerable latitude with regard to ingredients, claims, labeling, and disclaimers.

All 14 of the products identified for this study contained proteases of some type, though eight of the products failed to specify. Eleven of the products contained carbohydrases and/or lipases; neither of these types of enzymes degrade gluten proteins. Some products also contained probiotics.

A review of stated allergens was also conducted, as the FDA requires disclosure of “major allergens” by supplement manufacturers. Bacterial, fungal, and plant sources were all identified, though the origins of these ingredients were often not identified. One product even listed wheat as an ingredient.

Attention then turned to the claims made by the manufacturers. One of the products made no claims at all, while all the others claimed to degrade gluten fragments. These 13 products made a variety of additional claims, including alleviation of GI symptoms.

It is clear that the demand is high for additional therapies to aid with the management of celiac disease symptoms and adherence to a gluten-free diet. Researchers found (using Google AdWords) that frequency of searches for these glutenase products was 3,173 searches per month, only 75 times lower than the number of searches for “CD” and 24 times lower than “gluten-free.” Unfortunately, there is little evidence to support that these products actually meet their claims, and in fact, they may do more harm than good. Previous research has suggested that non-reported ingredients or substitution of ingredients can lead to gluten content over the recommended limit, even on products labeled “gluten-free.”

According to Dr. Benjamin Lebwohl, co-author of the study and CDF Research Committee member, “Though there are several promising leads in the quest to develop an effective non-dietary therapy for people with celiac disease, none are currently proven and available. But given the wide latitude granted to the supplement industry, a glutenase can be marketed and sold even if its effectiveness, or even safety, is totally unproven. For people with celiac disease who are interested in glutenases, the best way to go is to steer clear of these supplements and to consider participating in a clinical trial so that one day we will have a proven treatment.”

Good, solid research is being performed in the area of enzyme therapy for the treatment of celiac disease, with some studies already in clinical trials. Until those therapies are fully developed and safe, it is important that celiac disease patients exercise caution and a bit of skepticism in the use of dietary supplements, and that all such use be disclosed to medical providers.

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Assessing the Claims of Dietary Supplements

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