NCT04375449

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Ingredia S.A. · Industry
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Prediabetic State

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Pep2dia	what is the effect of Pep2dia on postprandial glycemia after a meal rich in carbohydrates (75g)
DIETARY_SUPPLEMENT	maltodextrin	maltodextrin

Timeline

• Start date: 2020-05-04
• Primary completion: 2020-07-25
• Completion: 2020-12-15
• First posted: 2020-05-05
• Last updated: 2022-05-11

Locations

1 site across 1 country: Germany