Aim of the study is to investigate the effect of two different dosages of milk peptides on postprandial blood glucose profile in prediabetic subjects compared to placebo. This will be investigated in a cross-over double blind randomized placebo controlled study design. Additionally, long term effects on glucose status, insulin sensitivity and postprandial blood glucose profile will be investigated in a follow up 6-week open label phase with the low dose only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
21
what is the effect of milk peptides 1400mg on postprandial glycemia after a meal rich in carbohydrates (75g)
what is the effect of milk peptides 2800mg on postprandial glycemia after a meal rich in carbohydrates (75g)
what is the effect of placebo on postprandial glycemia after a meal rich in carbohydrates (75g)
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
Time frame: day 1, day 8, day 15, day 57
Cmax
Maximum blood glucose concentration
Time frame: day 1, day 8, day 15, day 57
Max-Increase
Cmax minus baseline value
Time frame: day 1, day 8, day 15, day 57
Tmax
Time to reach maximum blood glucose concentration
Time frame: day 1, day 8, day 15, day 57
Tbaseline
First time to reach baseline again after increase or decrease in blood glucose
Time frame: day 1, day 8, day 15, day 57
AUC(0-180min):
Total area under curve from 0 to 180 min for blood glucose concentration
Time frame: day 1, day 8, day 15, day 57
Insulin-iAUC(0-180min)
Area under the curve calculated as the incremental area under the Insulin response curve, ignoring the area beneath the fasting concentration
Time frame: day 1, day 8, day 15, day 57
Cmax Baseline Insulin Max_increase Insulin
Max\_increase Insulin Cmax minus baseline insulin value
Time frame: day 1, day 8, day 15, day 57
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Tmax insulin
time to reach maximum Insulin concentration
Time frame: day 1, day 8, day 15, day 57
Fasting glucose, fasting insulin
Time frame: Baseline and Day 57
HOMA index
Parameters of insulin sensitivity:
Time frame: Baseline and Day 57
HbA1c level
HbA1c level after 6 weeks of supplementation
Time frame: Baseline (V5) and Day 57 (after 6 weeks)
Matsuda index
Insulin sensitivity
Time frame: Baseline and Day 57
Quicki Index
Insulin sensitivity
Time frame: Baseline and Day 57