Dietary Supplement
Conditions
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.
Interventions
DIETARY_SUPPLEMENTWhey Protein Micro Gel
The test product is whey protein microgels 10g, reconstituted in 125ml water.
OTHERWater without Whey Protein.
A matching placebo (125ml of water without whey protein) will be used as control.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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) |
| Plasma Gastric Inhibitory Polypeptide | -15, 0, 30, 60, 90, and 120 minutes. | Plasma GIP (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) |
| 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) |
| Plasma peptide | -15, 0, 30, 60, 90, and 120 minutes. | Plasma peptide-YY (PYY) (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) |
| Gastric emptying | -15, 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes. | Gastric emptying (AUC 0-4hours, Cmax and Tmax for acetaminophen) |
| 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 |
| Beta-cell function II | -15, 0, 30, 60, 90, and 120 minutes. | Beta-cell function II: Insulinogenic index (IGI): \[insulin (30-0 minutes) (μU/mL)/glucose (30-0 minutes) (mg/dL)\] |
| 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 |
| Total glucose | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. | Total glucose AUC (tAUC 0-3hours) |
| Plasma glucose | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. | Plasma glucose iCmax |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucagon | 0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes) | Plasma glucagon at individual timepoints |
| Plasma GLP-1 | -15, 0, 30, 60, 90, 120 minutes. | Plasma GLP-1 (iAUC 0-1hour, tAUC 0-1hour) |
| Plasma GIP | -15, 0, 30, 60, 90, 120 minutes. | Plasma GIP (iAUC 0-1hour, tAUC 0-1hour) |
| Serum triglycerides | -15, 0, 30, 60, 90, 120 minutes | Serum triglycerides (iAUC 0-1hour, tAUC 0-1hour) |
| Plasma ghrelin | -15, 0, 30, 60, 90, 120 minutes | Plasma ghrelin (iAUC 0-1hour, tAUC 0-1hour) |
| Plasma cholecystokinin | -15, 0, 30, 60, 90, 120 minutes | Plasma cholecystokinin (CCK) (iAUC 0-1hour, tAUC 0-1hour) |
| Plasma peptide | -15, 0, 30, 60, 90, 120 minutes. | Plasma peptide-YY (PYY) (iAUC 0-1hour, tAUC 0-1hour) |
| Serum insulin | 0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes | Serum insulin at individual timepoints |
| Plasma glucose | 0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes | Plasma glucose at individual timepoints |
Countries
United States
Outcome results
None listed