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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose Milk peptides | Active Comparator | 2800mg of whey protein hydrolysates single dose |
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| Low dose Milk peptides | Active Comparator | 1400mg of whey protein hydrolysate Single dose and 6 weeks intervention |
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| Placebo | Placebo Comparator | maltodextrin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose milk peptide | Dietary Supplement | what is the effect of milk peptides 1400mg on postprandial glycemia after a meal rich in carbohydrates (75g) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | day 1, day 8, day 15, day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum blood glucose concentration | day 1, day 8, day 15, day 57 |
| Max-Increase | Cmax minus baseline value | day 1, day 8, day 15, day 57 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Audrey BOULIER, MD | Ingredia S.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotesys | Esslingen am Neckar | Germany |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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double blind cross over and open for the phase II of the study
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first phase of the study is RCT double blind placebo cross-over. The second phase is open during 6 weeks of supplementation
| High Dose milk peptide | Dietary Supplement | what is the effect of milk peptides 2800mg on postprandial glycemia after a meal rich in carbohydrates (75g) |
|
| Placebo | Dietary Supplement | what is the effect of placebo on postprandial glycemia after a meal rich in carbohydrates (75g) |
|
| Tmax | Time to reach maximum blood glucose concentration | day 1, day 8, day 15, day 57 |
| Tbaseline | First time to reach baseline again after increase or decrease in blood glucose | day 1, day 8, day 15, day 57 |
| AUC(0-180min): | Total area under curve from 0 to 180 min for blood glucose concentration | 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 | day 1, day 8, day 15, day 57 |
| Cmax Baseline Insulin Max_increase Insulin | Max_increase Insulin Cmax minus baseline insulin value | day 1, day 8, day 15, day 57 |
| Tmax insulin | time to reach maximum Insulin concentration | day 1, day 8, day 15, day 57 |
| Fasting glucose, fasting insulin | Baseline and Day 57 |
| HOMA index | Parameters of insulin sensitivity: | Baseline and Day 57 |
| HbA1c level | HbA1c level after 6 weeks of supplementation | Baseline (V5) and Day 57 (after 6 weeks) |
| Matsuda index | Insulin sensitivity | Baseline and Day 57 |
| Quicki Index | Insulin sensitivity | Baseline and Day 57 |