Ingredion Submits Type 2 Diabetes Reduction Claim for Resistant Starch in US

16 Sep 2015 --- Ingredion Incorporated has submitted a health claim petition to the FDA for high-amylose corn resistant starch and reduction of risk for type 2 diabetes. Clinical studies conducted by academic institutions and research organizations* on high-amylose corn resistant starch type 2 (RS2) over the years, have generated considerable scientific data supporting the health benefits of this ingredient.

“We believe that there is consistent scientific evidence showing a clear link between consumption of resistant starch from high-amylose corn and reduction of risk for type 2 diabetes. Ingredion collaborated with external scientific and regulatory experts who indicated that these findings provide a strong basis for a health claim petition for reducing the risk for this disease,” indicated Christine Pelkman, PhD, Senior Nutrition Scientist and Clinical Research Manager at Ingredion. Eight well-controlled clinical trials showed HI-MAIZE resistant starch from high-amylose corn improved insulin sensitivity or other biomarkers accepted by the FDA as evidence for reduced risk for type 2 diabetes.

“Given current trends for type 2 diabetes rates and with nearly 80 million Americans at risk, we believe that ingredients such as HI-MAIZE resistant starch can be important contributors in the fight against this disease. Diets that incorporate increased consumption of resistant starch from high-amylose corn can have a substantial positive health impact on the American population,” added Lorraine Niba, PhD, Global Director, Nutrition at Ingredion. “HI-MAIZE resistant starch can help food manufacturers and formulators create innovative, healthier products that address one of the leading health concerns of consumers in the U.S.”

The petition underwent an initial review by the FDA and it was accepted for filing on July 8, 2015. After going through a public comment period, the petition is now under review as a qualified health claim. A final decision is expected in the first quarter of 2016 or later.

Lorraine Niba, PhD, MBA: Global Director, Nutrition Innovation noted to FoodIngredientsFirst that the petition is still under review by the FDA, and Ingredieon are therefore unable to give the particulars of the claim language as this will be decided by the authorities. “The FDA petition is for the US market, but it is a global product; we currently have claims in the EU and in Japan,” she added.

Christine L. Pelkman, PhD, Senior Nutrition Scientist and Clinical Research Manager at Ingredion explained that a health claim for reduction of blood sugar by resistant starch was approved in the EU and published in the Official Journal of the European Union on May 25, 2012 authorizing a "general function" Article 13.1 claim. The claim: “Replacing digestible starches with resistant starch in a meal contributes to a reduction in the blood glucose rise after that meal,” has the following conditions for use: “The claim may be used only for food in which digestible starch has been replaced by resistant starch so that the final content of resistant starch is at least 14% of total starch.”

HI-MAIZE resistant starch is a type of dietary fiber derived from a variety of corn that is high in amylose starch. This type of starch is resistant to digestion and acts like fiber in the human digestive tract. It is a white powder with a mild taste that is easily incorporated into everyday foods such as pasta, smoothies, bread, muffins and other baked goods.

*Over 70 human clinical trials have been conducted on high-amylose corn resistant starch over the years. This includes Ingredion funded and independent research. A complete list of references can be provided upon request.

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