Pep2Dia, a whey protein hydrolysate, recently received approval from the U.S. Food and Drug Administration for its New Dietary Ingredient Notification (NDIN).
 
The agency found Ingredia Nutritional's ingredient to be safe when taken for its intended use in foods and dietary supplements based on evaluations of its toxicity both acutely (at a dose of 2,000 mg/kg body weight) and sub chronically (90 days at dose levels up to 1,000 mg/kg body weight per day). In both of these studies, no toxicological effects were observed.
 
Pep2Dia is a whey protein hydrolysate which contains an active dipeptide AP, which has been clinically investigated for its benefits in helping maintain normal blood sugar levels. The ingredient is formulated with glucose intolerant or prediabetic people in mind, who are healthy but have glycaemia levels irregularly above normal and experience a higher risk of developing Type 2 diabetes. This is because the peptide AP acts as an inhibitor of a-glucosidase, which is evidenced to lower absorption of glucose into the bloodstream.
 
One clinical study showed that the ingredient achieved clinically-significant decreases in HbA1c levels in glucose intolerant volunteers when taken daily with a meal for 6 weeks at a dose of 1400 mg, the company reports. In a more recent clinical study which took place in 2020, it was found that 700 mg before meals was an efficacious dose for significant HbA1C reductions in glucose intolerant people.
 
375 million people are at risk of getting type 2 diabetes, according to the International Diabetes Federation, and approximately 80% of prediabetic people will develop diabetes in 5-10 years if nothing is done. While 88 million adults, mostly over the age of 45, had prediabetes in 2018, only 15.3% of prediabetic adults are aware of it, according to CDC data.