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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
36
what is the effect of Pep2dia on postprandial glycemia after a meal rich in carbohydrates (75g)
maltodextrin
Biotesys
Esslingen am Neckar, Germany
Glucose-iAUC(0-180min)
Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration (according to ISO 26642:2010(E)
Time frame: Day 1, Day 15, Day 29
Cmax
Maximum blood glucose concentration
Time frame: Day 1, Day 15, Day 29
Max_increase
Cmax minus baseline value
Time frame: Day 1, Day 15, Day 29
Tmax
Time to reach maximum blood glucose concentration
Time frame: Day 1, Day 15, Day 29
Tbaseline
First time to reach baseline again after increase or decrease in blood glucose
Time frame: Day 1, Day 15, Day 29
AUC(0-180min)
Total area under curve from 0 to 180 min for blood glucose concentration
Time frame: Day 1, Day 15, Day 29
Matsuda index
Marker of insulin sensitivity
Time frame: Day 1, Day 15, Day 29
Increase of insulin
Area under the curve calculated as the incremental area under the Insulin response curve, ignoring the area beneath the fasting concentration (Insulin-iAUC(0-180min)). If applicable further pharmacokinetic data from insulin increase will be calculated (e.g. Cmax, Tmax)
Time frame: Day 1, Day 15, Day 29
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GLP-1-iAUC(0-120min)
120 min postprandial incretin response in terms of Glucagon-like Peptide-1
Time frame: Day 1, Day 15, Day 29