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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen hydrolysate | Active Comparator | 30 min prior to the mixed meal test |
|
| Placebo | Placebo Comparator | Flavoured water |
|
| Collagen hydrolysate II | Other | together with the mixed meal test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen hydrolyzed peptides | Dietary Supplement | Dissolved in flavoured water, single dose, 10 g |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 0-180 minutes postprandially |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Cmax | Maximum blood glucose concentration (Cmax) | 0-180 minutes postprandially |
| Delta Cmax | Maximum increase of blood glucose concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal hormones | Glucose-dependent insulinotropic polypeptide (GIP) | 0-120 minutes postprandially |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioTeSys GmbH | Esslingen am Neckar | 73728 | Germany |
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| Placebo | Other | Single dose |
|
| 0-180 minutes postprandially |
| Tmax | Time to reach maximum blood glucose concentration (Tmax) | 0-180 minutes postprandially |
| Fasting glucose | Fasting glucose | -30 minutes and 0 minutes prior mixed meal |
| Glucose | Blood glucose concentration after mixed meal | 120 minutes |
| Fasting insulin | Fasting insulin | -30 minutes and 0 minutes prior to mixed meal |
| Insulin iAUC | Area under the curve calculated as the incremental area under the insulin curve | 0-180 minutes postprandially |
| Fasting C-peptide | Fasting C-peptide | -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 | 0-180 minutes postprandially |
| GLP-1 iAUC | Incretin response (Glucagon-like Peptide-1) | 0-120 minutes postprandially |
| Fasting GLP-1 | Fasting GLP-1 | -30 minutes and 0 minutes prior mixed meal |
| Matsuda-Index | Determination of Insulin sensitivity | 0-120 minutes postprandially |
| Gastric emptying | Time for gastric emptying | 0-6 hours postprandially |
| Satiety assessment | Visual analog scale (VAS) Scale (0: not at all 100: extremely) | 0-240 minutes postprandially |
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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