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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
26
The test product is whey protein microgels 10g, reconstituted in 125ml water.
A matching placebo (125ml of water without whey protein) will be used as control.
Orange County Research Center
Tustin, California, United States
Post-prandial glycemic excursion.
Incremental area under the curve post-prandial glycemic excursion (iAUC 0-3 hours)
Time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
2h post-prandial glucose
Incremental area under the curve 2hours post-prandial glucose levels
Time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Total glucose
Total glucose AUC (tAUC 0-3hours)
Time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Plasma glucose
Plasma glucose iCmax
Time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Plasma glucose
Plasma glucose Tmax
Time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Plasma glucose
Plasma glucose AUC (iAUC 0-4hours, tAUC 0-4hours)
Time frame: -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)
Time frame: -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)
Time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
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Plasma Glucagon-like Peptide-1
Plasma GLP-1 (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Time frame: -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)
Time frame: -15, 0, 30, 60, 90, and 120 minutes.
Plasma ghrelin
Plasma ghrelin (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Time frame: -15, 0, 30, 60, 90, and 120 minutes.
Plasma cholecystokinin
Plasma cholecystokinin (CCK) (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Time frame: -15, 0, 30, 60, 90, and 120 minutes.
Plasma peptide
Plasma peptide-YY (PYY) (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Time frame: -15, 0, 30, 60, 90, and 120 minutes.
Serum triglycerides
Serum triglycerides (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Time frame: -15, 0, 30, 60, 90, and 120 minutes.
Gastric emptying
Gastric emptying (AUC 0-4hours, Cmax and Tmax for acetaminophen)
Time frame: -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
Time frame: -15, 0, 30, 60, 90, and 120 minutes.
Beta-cell function II
Beta-cell function II: Insulinogenic index (IGI): \[insulin (30-0 minutes) (μU/mL)/glucose (30-0 minutes) (mg/dL)\]
Time frame: -15, 0, 30, 60, 90, and 120 minutes.