NCT04639726CompletedNot Applicable
A Randomized, Placebo-Controlled, Single-Center, Crossover Study to Evaluate the Effects of Pre-Meal Whey Protein Microgels Administration on Post-Prandial Glycemic Response in Patients with Type 2 Diabetes.
Société des Produits Nestlé (SPN)1 site in 1 country26 target enrollmentStarted: September 28, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Post-prandial glycemic excursion.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •Fasting plasma glucose >220mg/dl at screening.
- •Impaired kidney function, epidermal growth factor receptor of <60mL/min/1.73m2 at screening.
- •BMI >40kg/m
- •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.
Arms & Interventions
Whey Protein
Active Comparator
Intervention: Whey Protein Micro Gel (Dietary Supplement)
Placebo
Placebo Comparator
Intervention: Water without Whey Protein. (Other)
Outcomes
Primary Outcomes
Post-prandial glycemic excursion.
Time Frame: -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 Outcomes
- Serum triglycerides(-15, 0, 30, 60, 90, and 120 minutes.)
- Plasma glucose(-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.)
- Plasma glucagon(-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.)
- Beta-cell function I(-15, 0, 30, 60, 90, and 120 minutes.)
- Total glucose(-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.)
- Serum insulin(-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.)
- Plasma ghrelin(-15, 0, 30, 60, 90, and 120 minutes.)
- Plasma cholecystokinin(-15, 0, 30, 60, 90, and 120 minutes.)
- Plasma Gastric Inhibitory Polypeptide(-15, 0, 30, 60, 90, and 120 minutes.)
- Gastric emptying(-15, 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes.)
- Beta-cell function II(-15, 0, 30, 60, 90, and 120 minutes.)
- 2h post-prandial glucose(-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.)
- Plasma peptide(-15, 0, 30, 60, 90, and 120 minutes.)
- Plasma Glucagon-like Peptide-1(-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.)
Investigators
Study Sites (1)
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