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This is a mechanistic, randomized, investigator-blinded, placebo-controlled, single-center, crossover study designed to evaluate the effects of premeal administration of whey protein microgels compared to placebo on postprandial glycemia in patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey Protein | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey Protein Micro Gel | Dietary Supplement | The test product is whey protein microgels 10g, reconstituted in 125ml water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-prandial glycemic excursion. | Incremental area under the curve post-prandial glycemic excursion (iAUC 0-3 hours) | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| 2h post-prandial glucose | Incremental area under the curve 2hours post-prandial glucose levels | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. |
| Total glucose | Total glucose AUC (tAUC 0-3hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose | Plasma glucose at individual timepoints | 0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes |
| Serum insulin | Serum insulin at individual timepoints |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel M Neutel, MD | Orange County Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Tustin | California | 92780 | United States |
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| ID | Term |
|---|---|
| D014867 | Water |
| D000067816 | Whey Proteins |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| Water without Whey Protein. | Other | A matching placebo (125ml of water without whey protein) will be used as control. |
|
| -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. |
| Plasma glucose | Plasma glucose iCmax | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. |
| Plasma glucose | Plasma glucose Tmax | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. |
| Plasma glucose | Plasma glucose AUC (iAUC 0-4hours, tAUC 0-4hours) | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. |
| Serum insulin | Serum insulin (iAUC 0-3hours, iCmax, Tmax, tAUC 0-3hours) | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. |
| Plasma glucagon | Plasma glucagon (iAUC 0-3hours, iCmax, Tmax, tAUC 0-3hours) | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. |
| Plasma Glucagon-like Peptide-1 | Plasma GLP-1 (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. |
| Plasma Gastric Inhibitory Polypeptide | Plasma GIP (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -15, 0, 30, 60, 90, and 120 minutes. |
| Plasma ghrelin | Plasma ghrelin (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -15, 0, 30, 60, 90, and 120 minutes. |
| Plasma cholecystokinin | Plasma cholecystokinin (CCK) (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -15, 0, 30, 60, 90, and 120 minutes. |
| Plasma peptide | Plasma peptide-YY (PYY) (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -15, 0, 30, 60, 90, and 120 minutes. |
| Serum triglycerides | Serum triglycerides (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -15, 0, 30, 60, 90, and 120 minutes. |
| Gastric emptying | Gastric emptying (AUC 0-4hours, Cmax and Tmax for acetaminophen) | -15, 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes. |
| Beta-cell function I | Beta-cell function I: AUC insulin 0-3hours: AUC glucose 0-3hours ratio | -15, 0, 30, 60, 90, and 120 minutes. |
| Beta-cell function II | Beta-cell function II: Insulinogenic index (IGI): [insulin (30-0 minutes) (μU/mL)/glucose (30-0 minutes) (mg/dL)] | -15, 0, 30, 60, 90, and 120 minutes. |
| 0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes |
| Plasma glucagon | Plasma glucagon at individual timepoints | 0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes) |
| Plasma glucose | Plasma glucose (iAUC 0-2hours, iAUC 0-1hour, tAUC 0-2hours, tAUC 0-1hour) | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. |
| Serum insulin | Serum insulin (iAUC 0-4hours, tAUC 0-4hours, iAUC 0-2hours, tAUC 0-2hours, iAUC 0-1hour, tAUC 0-1hour) | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. |
| Plasma glucagon | Plasma glucagon (iAUC 0-4hours, tAUC 0-4hours, iAUC 0-2hours, tAUC 0-2hours, iAUC 0-1hour, tAUC 0-1hour) | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. |
| Plasma GLP-1 | Plasma GLP-1 (iAUC 0-1hour, tAUC 0-1hour) | -15, 0, 30, 60, 90, 120 minutes. |
| Plasma GIP | Plasma GIP (iAUC 0-1hour, tAUC 0-1hour) | -15, 0, 30, 60, 90, 120 minutes. |
| Serum triglycerides | Serum triglycerides (iAUC 0-1hour, tAUC 0-1hour) | -15, 0, 30, 60, 90, 120 minutes |
| Plasma ghrelin | Plasma ghrelin (iAUC 0-1hour, tAUC 0-1hour) | -15, 0, 30, 60, 90, 120 minutes |
| Plasma cholecystokinin | Plasma cholecystokinin (CCK) (iAUC 0-1hour, tAUC 0-1hour) | -15, 0, 30, 60, 90, 120 minutes |
| Plasma peptide | Plasma peptide-YY (PYY) (iAUC 0-1hour, tAUC 0-1hour) | -15, 0, 30, 60, 90, 120 minutes. |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |