Dietary Supplement Clinical Trial
Official title:
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.
Verified date | October 2020 |
Source | Nestlé |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | October 26, 2020 |
Est. primary completion date | October 26, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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/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. |
Country | Name | City | State |
---|---|---|---|
United States | Orange County Research Center | Tustin | California |
Lead Sponsor | Collaborator |
---|---|
Nestlé |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Plasma glucose | Plasma glucose at individual timepoints | 0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes | |
Other | Serum insulin | Serum insulin at individual timepoints | 0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes | |
Other | Plasma glucagon | Plasma glucagon at individual timepoints | 0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes) | |
Other | 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. | |
Other | 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. | |
Other | 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. | |
Other | Plasma GLP-1 | Plasma GLP-1 (iAUC 0-1hour, tAUC 0-1hour) | -15, 0, 30, 60, 90, 120 minutes. | |
Other | Plasma GIP | Plasma GIP (iAUC 0-1hour, tAUC 0-1hour) | -15, 0, 30, 60, 90, 120 minutes. | |
Other | Serum triglycerides | Serum triglycerides (iAUC 0-1hour, tAUC 0-1hour) | -15, 0, 30, 60, 90, 120 minutes | |
Other | Plasma ghrelin | Plasma ghrelin (iAUC 0-1hour, tAUC 0-1hour) | -15, 0, 30, 60, 90, 120 minutes | |
Other | Plasma cholecystokinin | Plasma cholecystokinin (CCK) (iAUC 0-1hour, tAUC 0-1hour) | -15, 0, 30, 60, 90, 120 minutes | |
Other | Plasma peptide | Plasma peptide-YY (PYY) (iAUC 0-1hour, tAUC 0-1hour) | -15, 0, 30, 60, 90, 120 minutes. | |
Primary | 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. | |
Secondary | 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. | |
Secondary | Total glucose | Total glucose AUC (tAUC 0-3hours) | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. | |
Secondary | Plasma glucose | Plasma glucose iCmax | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. | |
Secondary | Plasma glucose | Plasma glucose Tmax | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. | |
Secondary | Plasma glucose | Plasma glucose AUC (iAUC 0-4hours, tAUC 0-4hours) | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | Plasma Gastric Inhibitory Polypeptide | Plasma GIP (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -15, 0, 30, 60, 90, and 120 minutes. | |
Secondary | Plasma ghrelin | Plasma ghrelin (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -15, 0, 30, 60, 90, and 120 minutes. | |
Secondary | Plasma cholecystokinin | Plasma cholecystokinin (CCK) (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -15, 0, 30, 60, 90, and 120 minutes. | |
Secondary | Plasma peptide | Plasma peptide-YY (PYY) (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -15, 0, 30, 60, 90, and 120 minutes. | |
Secondary | Serum triglycerides | Serum triglycerides (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -15, 0, 30, 60, 90, and 120 minutes. | |
Secondary | Gastric emptying | Gastric emptying (AUC 0-4hours, Cmax and Tmax for acetaminophen) | -15, 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes. | |
Secondary | 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. | |
Secondary | 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. |
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