A Study to Evaluate the Effects of Pre-Meal Whey Protein Microgels Administration on Post-Prandial Glycemic Response.
- Conditions
- Dietary Supplement
- Interventions
- Other: Water without Whey Protein.Dietary Supplement: Whey Protein Micro Gel
- Registration Number
- NCT04639726
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Willing and able to sign written informed consent prior to study entry.
- Male or female, >18 years of age.
- Established diagnosis of type 2 diabetes (documented by either HbA1c 6.5 - 10.0% or a history of type 2 diabetes diagnosis).
- Treatment naïve or on active therapy with metformin at a daily dose of 1000-3000mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
- Patients must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
- Patients must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males.
- Fasting plasma glucose >220mg/dl at screening.
- Impaired kidney function, epidermal growth factor receptor of <60mL/min/1.73m2 at screening.
- BMI >40kg/m2.
- Elevated liver transaminase > 3 upper limit of normal at screening.
- Ongoing or recent (i.e. < 3month) treatment with any oral or injectable glucose-lowering drug other than metformin.
- Ongoing or recent (i.e. < 3month) injectable insulin therapy.
- Ongoing or recent (i.e. < 3 month) weight loss interventions (e.g. dietary weight loss programs) or any history of bariatric surgery or any documented weight loss >5% within previous 6 months.
- Ongoing or recent (i.e. < 3 month) treatment with anorectic drugs, systemic steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption.
- Major medical/surgical event requiring hospitalization in the last 3 months.
- Known allergy and intolerance to product components or acetaminophen.
- Alcohol intake higher than 2 servings per day. A serving is 0.4dl of strong alcohols, 1dl of red or white wine, or 3dl of beer.
- Are unable to comply with protocol procedures in the opinion of the investigator.
- Have a hierarchical link with the research team members.
- Positive pregnancy test at screening.
- Patients who have been dosed in another clinical trial with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening, or patients currently participating in any investigational trial.
- Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Patients must also agree to not donate blood within 8 weeks after their last visit.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Water without Whey Protein. - Whey Protein Whey Protein Micro Gel -
- Primary Outcome Measures
Name Time Method Post-prandial glycemic excursion. -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. Incremental area under the curve post-prandial glycemic excursion (iAUC 0-3 hours)
- Secondary Outcome Measures
Name Time Method Beta-cell function II -15, 0, 30, 60, 90, and 120 minutes. Beta-cell function II: Insulinogenic index (IGI): \[insulin (30-0 minutes) (μU/mL)/glucose (30-0 minutes) (mg/dL)\]
Plasma glucagon -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. Plasma glucagon (iAUC 0-3hours, iCmax, Tmax, tAUC 0-3hours)
Beta-cell function I -15, 0, 30, 60, 90, and 120 minutes. Beta-cell function I: AUC insulin 0-3hours: AUC glucose 0-3hours ratio
Total glucose -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. Total glucose AUC (tAUC 0-3hours)
Serum insulin -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. Serum insulin (iAUC 0-3hours, iCmax, Tmax, tAUC 0-3hours)
Plasma ghrelin -15, 0, 30, 60, 90, and 120 minutes. Plasma ghrelin (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Plasma cholecystokinin -15, 0, 30, 60, 90, and 120 minutes. Plasma cholecystokinin (CCK) (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Serum triglycerides -15, 0, 30, 60, 90, and 120 minutes. Serum triglycerides (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Plasma glucose -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. Plasma glucose AUC (iAUC 0-4hours, tAUC 0-4hours)
Plasma Gastric Inhibitory Polypeptide -15, 0, 30, 60, 90, and 120 minutes. Plasma GIP (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Gastric emptying -15, 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes. Gastric emptying (AUC 0-4hours, Cmax and Tmax for acetaminophen)
2h post-prandial glucose -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. Incremental area under the curve 2hours post-prandial glucose levels
Plasma peptide -15, 0, 30, 60, 90, and 120 minutes. Plasma peptide-YY (PYY) (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Plasma Glucagon-like Peptide-1 -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. Plasma GLP-1 (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Trial Locations
- Locations (1)
Orange County Research Center
🇺🇸Tustin, California, United States