Aim of the study is to investigate the postprandial response on blood glucose, insulin, C-peptide, incretin response and gastric emptying after intake of collagen hydrolysate compared to placebo in normoglycemic and in prediabetic participants. This will be investigated in a cross-over randomized double-blind placebo controlled study design. In an exploratory part II, timing of intake of collagen hydrolysate in relation to the mixed meal will be investigated in a subgroup of 50% of the participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
30
Dissolved in flavoured water, single dose, 10 g
Single dose
BioTeSys GmbH
Esslingen am Neckar, Germany
Glucose iAUC
Area under the curve (AUC) calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration: Glucose-iAUC(0-180minutes)
Time frame: 0-180 minutes postprandially
Glucose Cmax
Maximum blood glucose concentration (Cmax)
Time frame: 0-180 minutes postprandially
Delta Cmax
Maximum increase of blood glucose concentration
Time frame: 0-180 minutes postprandially
Tmax
Time to reach maximum blood glucose concentration (Tmax)
Time frame: 0-180 minutes postprandially
Fasting glucose
Fasting glucose
Time frame: -30 minutes and 0 minutes prior mixed meal
Glucose
Blood glucose concentration after mixed meal
Time frame: 120 minutes
Fasting insulin
Fasting insulin
Time frame: -30 minutes and 0 minutes prior to mixed meal
Insulin iAUC
Area under the curve calculated as the incremental area under the insulin curve
Time frame: 0-180 minutes postprandially
Fasting C-peptide
Fasting C-peptide
Time frame: -30 minutes and 0 minutes prior mixed meal
C-peptide iAUC
Area under the curve calculated as the incremental area under the C-peptide curve
Time frame: 0-180 minutes postprandially
GLP-1 iAUC
Incretin response (Glucagon-like Peptide-1)
Time frame: 0-120 minutes postprandially
Fasting GLP-1
Fasting GLP-1
Time frame: -30 minutes and 0 minutes prior mixed meal
Matsuda-Index
Determination of Insulin sensitivity
Time frame: 0-120 minutes postprandially
Gastric emptying
Time for gastric emptying
Time frame: 0-6 hours postprandially
Satiety assessment
Visual analog scale (VAS) Scale (0: not at all 100: extremely)
Time frame: 0-240 minutes postprandially
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