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| Name | Class |
|---|---|
| BioTeSys GmbH | OTHER |
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To investigate the effect of two different dosages collagen hydrolysate (CH) on postprandial blood glucose and insulin profile in prediabetic and normo-glycaemic subjects.This will be investigated in a cross-over randomized double-blind placebo controlled study design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen hydrolysate dose 1 | Experimental | Source: porcine; standardized to 10 g provided as single dose. Orally applied in flavoured water. |
|
| Collagen hydrolysate dose 2 | Experimental | Source: porcine; standardized to 5 g provided as single dose. Orally applied in flavoured water. |
|
| Placebo | Placebo Comparator | Flavoured water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen hydrolysate | Dietary Supplement | Single dose |
|
| 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 iAUC | Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration: Glucose-iAUC(0-240minutes) | 0-240 minutes postprandially |
| Glucose Cmax |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal hormones | Peptid YY (PYY), Ghrelin, Cholecystokinin (CCK), Leptin | 0-120 minutes postprandially |
| Amino acids | Concentration-time curve of amino acids in plasma together with small molecular weight peptides |
Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicoletta Virgilio, PhD | Rousselot BV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioTeSys GmbH | Esslingen am Neckar | 73728 | Germany |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Other | Single dose |
|
Maximum blood glucose concentration (Cmax)
| 0-180 minutes postprandially |
| Delta Cmax | Maximum increase of blood glucose concentration | 0-180 minutes postprandially |
| Tmax | Time to reach maximum blood glucose concentration (Tmax) | 0-180 minutes postprandially |
| T baseline | First time to reach baseline again after increase or decrease in blood glucose | 0-240 minutes postprandially |
| Matsuda-Index | Determination of Insulin sensitivity | 0-120 minutes postprandially |
| Glucose dip | maximum dip below baseline and time point of glucose dip | 0-240 minutes postprandially |
| Insulin iAUC | Area under the curve calculated as the incremental area under the insulin curve | up to 0-240 minutes postprandially |
| GLP-1 | Incretin response (Glucagon-like Peptide-1) | 0-120 minutes postprandially |
| Satiety assessment | Visual analog scale (VAS) Scale (0: not at all 100: extremely) | 0-240 minutes postprandially |
| 0-240 minutes postprandially |
| D004700 | Endocrine System Diseases |