Pep2Dia®’s New Dietary Ingredient (NDI) registration approved by the US FDA

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Ingredia has now been granted the New Dietary Ingredient (NDI) registration for Pep2Dia®!

Special thanks to Sylvanie Seret and our experts, who guided us throughout the process.

What is Pep2Dia®?

Pep2Dia® is a patented whey protein hydrolysate containing an active dipeptide AP, designed for people willing to maintain healthy blood sugar levels. Among them are glucose intolerant or prediabetic people, a healthy population with glycaemia levels irregularly above normal and with a higher risk of developing type 2 diabetes. 

The peptide AP acts as an inhibitor of the α-glucosidase, thus lowers glucose absorption into the blood stream.

Pep2Dia®’s safety validated by NDI registration

Pep2Dia®’s toxicity was evaluated, both acutely (dose of 2000 mg/kg body weight) and sub chronically (90 days at dose levels up to 1000mg/kg body weight/day). In both studies, no toxicological effects were observed.

Previously, Pep2Dia® had proven its efficacy in clinical studies (2019) in glucose intolerant volunteers, at a dose of 1400 mg to be taken daily before lunch for 6 weeks as a supplement. It has successfully decreased their glycated hemoglobin (HbA1c) level. Pep2Dia® thus lowers the risk of developing type 2 diabetes.

More news for Pep2Dia®

Our most recent clinical study (2020) proves Pep2Dia®’s efficacy at a dose of 700 mg before meals, on glucose intolerant people.

The future of type 2 diabetes market

In 2019, 375 million people worldwide were at risk of getting type 2 diabetes. 80% of those prediabetic people will develop type 2 diabetes within 5 to 10 years if nothing is done [1].

In the US, about 88 million adults had prediabetes in 2018 with 67% of them being 45 or older.

Only 15.3% of them were aware of it and according to Centers for Diseases Control, the percentage who had ever been told by a health care professional that they had prediabetes has doubled over the 2005-2016 period [2].

Knowing prediabetes is a reversible state, this high prevalence makes prevention all the more crucial.

Contact us today!

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[1] IDF Atlas, 2019.

[2]CDC, 2021.