A Study to Evaluate the Effects of Pre-Meal Whey Protein Microgels Administration on Post-Prandial Glycemic Response.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Dietary Supplement

Intervention / Treatment
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* Dietary Supplement: Whey Protein Micro Gel
* Other: Water without Whey Protein.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whey Protein<br> | Dietary Supplement: Whey Protein Micro Gel<br>* The test product is whey protein microgels 10g, reconstituted in 125ml water.<br>|
| Placebo Comparator: Placebo<br> | Other: Water without Whey Protein.<br>* A matching placebo (125ml of water without whey protein) will be used as control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Total glucose | Total glucose AUC (tAUC 0-3hours) | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. | 
| Plasma glucose | Plasma glucose iCmax | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. | 
| Plasma glucose | Plasma glucose Tmax | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. | 
| Plasma glucose | Plasma glucose AUC (iAUC 0-4hours, tAUC 0-4hours) | -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) | -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) | -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes. | 
| 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. | 
| Plasma Gastric Inhibitory Polypeptide | Plasma GIP (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -15, 0, 30, 60, 90, and 120 minutes. | 
| Plasma ghrelin | Plasma ghrelin (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -15, 0, 30, 60, 90, and 120 minutes. | 
| Plasma cholecystokinin | Plasma cholecystokinin (CCK) (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -15, 0, 30, 60, 90, and 120 minutes. | 
| Plasma peptide | Plasma peptide-YY (PYY) (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -15, 0, 30, 60, 90, and 120 minutes. | 
| Serum triglycerides | Serum triglycerides (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours) | -15, 0, 30, 60, 90, and 120 minutes. | 
| Gastric emptying | Gastric emptying (AUC 0-4hours, Cmax and Tmax for acetaminophen) | -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 | -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)] | -15, 0, 30, 60, 90, and 120 minutes. |