Investigation of Milk Peptides (Pep2Dia®) on Postprandial Blood Glucose Profile in Prediabetic Subjects

Prediabetic State Clinical Trial

Official title: Investigation of Milk Peptides (Pep2Dia®) on Postprandial Blood Glucose Profile in Prediabetic Subjects: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages

Status Completed

Clinical Trial Summary

The goal is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min prior to a standardized challenge meal.

Clinical Trial Description

From a previous pilot study (BTS1130/17) there is first evidence that the native whey product with alpha-glucosidase inhibiting properties (Pep2Dia®) has the potential to modulate postprandial hyperglycaemia in prediabetic subjects. Thereby, incremental areas under the curve (iAUC) of glucose as the primary outcome were significantly reduced by a single dosage of 1400 mg Pep2Dia® compared to placebo the second study is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min prior to a standardized challenge meal. Furthermore, the 120 min postprandial incretin response in terms of Glucagon-like Peptide-1 (GLP-1) will be determined. Changes in insulin sensitivity will be determined by the Matsuda-index as appropriate outcome measure. ;

Related Conditions & MeSH terms

• Prediabetic State

• NCT number: NCT04375449
• Study type: Interventional
• Source: Ingredia S.A.
• Status: Completed
• Phase: N/A
• Start date: May 4, 2020
• Completion date: December 15, 2020