Ingredion petitions FDA for diabetes risk reduction health claim


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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. Image: © iStockPhoto
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. Image: © iStockPhoto

Related tags: Nutrition

Ingredion has submitted a health claim petition to the FDA for its Hi-Maize high-amylose corn resistant starch and reduction of risk for type 2 diabetes.

Following its acceptance by the FDA on July 8, 2015 and 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.

“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,”​ said Christine Pelkman, PhD, Senior Nutrition Scientist and Clinical Research Manager at Ingredion.

“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.”

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, said the company in a release.

Qualified health claims

If the petition is successful, the claim would have to carry a qualification similar to that which accompanies P&G’s successful psyllium husk claim​. The FDA allows for the following claim statements to be made:

Psyllium husk may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very little scientific evidence for this claim.
Psyllium husk may reduce the risk of type 2 diabetes.  FDA has concluded that there is very little scientific evidence for this claim.

The statements regarding the FDA’s conclusion of “very little evidence for the claim​” has led to some industry observers to question the value of qualified health claims.

However, Lorraine Niba, PhD, MBA: Global Director, Nutrition Innovation for Ingredion, told us that some of the most successful nutritional ingredients have qualified health claims, and noted that omega-3s saw a substantial growth in the market when they obtained a qualified health claim.

“There are only very few ingredients that have an SSA claim, typically ingredients that have an extensive body of clinical and epidemiological evidence over several years of being in the food supply,” ​she said. “We do not believe that the disclaimers detract from the value of the claim; they in fact serve a purpose in informing and educating the consumer about the nature of claims.”

“Glycemic health and diabetes prevention are leading concerns for US consumers today,” ​added Dr Niba. “While Ingredion cannot comment on the use of claims by other ingredient manufacturers, consumer trend surveys indicate sustained interest in foods and ingredients that help reduce the risk of type 2 diabetes.”

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good article!

Posted by davinder,

To reduce our risk for Type 2 Diabetes and the other diseases associated with it, we are urged to “eat a healthy diet” which -- in the minds of many professionals as well as the general public -- means a diet low in fat, especially saturated fat.
Yet decades of studies have found no link between saturated fats and diabetes -- in fact there is evidence suggesting that the risk may be elevated by the oils consumed in place of saturated fats.
Sugar consumption tends to increase when the diet is lacking in saturated fats, thereby raising the level of risk even higher. These factors need to be acknowledged and fully understood by all concerned, including the media.

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Posted by marry,

I was diagnosed with type 2 Diabetes and put on Metformin on June 26th, 2014. I started the ADA diet and followed it 100% for a few weeks and could not get my blood sugar to go below 140. Finally i began to panic and called my doctor, he told me to get used to it. He said I would be on metformin my whole life and eventually insulin. At that point i knew something wasn't right and began to do a lot of research. On April 13th I found this book on I read the book from end to end that night because everything the writer was saying made absolute sense. I started the diet that day and the next morning my blood sugar was down to 100, the next day was in the 90's and now i have a fasting blood sugar between Mid 70's and the 80's. My doctor took me off the metformin after just one week of being on this lifestyle change. I have lost over 30 pounds in a month. I now work out twice a day and still have tons of energy. I have lost 6+ inches around my waist and I am off my high blood pressure medication too. I have about 20 more pounds to go till my body finds its ideal weight. The great news is, this is a lifestyle I can live with, it makes sense and it works. God Bless the writer. I wish the ADA would stop enabling consumers and tell them the truth. You can get off the drugs, you can help yourself, but you have to have a correct lifestyle and diet. No more processed foods.

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Posted by Marcia,

I got diagnosed with Type 2 Diabetes last year, and was put on Metformin. I followed the ADA diet 100% for a few weeks but it was ineffective at getting my blood sugar below 140. My Doctor was pretty ineffective as far as treatment options went (Metformin until Insulin...). Then I found the Diabetes Destroyer Book - - created by David Andrews to help you figure out how to beat diabetes naturally, without being dependent on medications. Since following that protocol I've lost over 30 pounds and shaved 7 inches off my waist. I have more energy than ever, and can even work out twice on the same day when I feel like it. I hope that more people begin to open their eyes to the dead-end that is depending only on medications for Diabetes - there is a lot of success to be seen trying natural methods.

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