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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 28, 2021

Interventions

  • Dietary Supplement: Whey Protein Micro Gel
    • The test product is whey protein microgels 10g, reconstituted in 125ml water.
  • Other: Water without Whey Protein.
    • A matching placebo (125ml of water without whey protein) will be used as control.

Arms, Groups and Cohorts

  • Active Comparator: Whey Protein
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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 0-3h)

Secondary Measures

  • 2h post-prandial glucose
    • Time Frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
    • Incremental area under the curve 2h post-prandial glucose levels
  • Total glucose
    • Time Frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
    • Total glucose AUC (tAUC 0-3h)
  • Plasma glucose
    • Time Frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
    • Plasma glucose iCmax
  • Plasma glucose
    • Time Frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
    • Plasma glucose Tmax
  • Plasma glucose
    • Time Frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
    • Plasma glucose AUC (iAUC 0-4h, tAUC 0-4h)
  • Serum insulin
    • Time Frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
    • Serum insulin (iAUC 0-3h, iCmax, Tmax, tAUC 0-3h)
  • Plasma glucagon
    • Time Frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
    • Plasma glucagon (iAUC 0-3h, iCmax, Tmax, tAUC 0-3h)
  • Plasma Glucagon-like Peptide-1
    • Time Frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
    • Plasma GLP-1 (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
  • Plasma Gastric Inhibitory Polypeptide
    • Time Frame: -15 min, 0, 30, 60, 90, and 120 mins.
    • Plasma GIP (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
  • Plasma ghrelin
    • Time Frame: -15 min, 0, 30, 60, 90, and 120 mins.
    • Plasma ghrelin (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
  • Plasma cholecystokinin
    • Time Frame: -15 min, 0, 30, 60, 90, and 120 mins.
    • Plasma cholecystokinin (CCK) (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
  • Plasma peptide
    • Time Frame: -15 min, 0, 30, 60, 90, and 120 mins.
    • Plasma peptide-YY (PYY) (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
  • Serum triglycerides
    • Time Frame: -15 min, 0, 30, 60, 90, and 120 mins.
    • Serum triglycerides (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
  • Gastric emptying
    • Time Frame: -15 min, 0, 15, 30, 45, 60, 90, 120, 180, and 240 mins.
    • Gastric emptying (AUC 0-4h, Cmax and Tmax for acetaminophen)
  • Beta-cell function I
    • Time Frame: -15 min, 0, 30, 60, 90, and 120 mins.
    • Beta-cell function I: AUC insulin 0-3 h: AUC glucose 0-3 h ratio
  • Beta-cell function II
    • Time Frame: -15 min, 0, 30, 60, 90, and 120 mins.
    • Beta-cell function II: Insulinogenic index (IGI): [insulin (30-0 min) (μU/mL)/glucose (30-0 min) (mg/dL)]

Participating in This Clinical Trial

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.
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Nestlé
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Joel M Neutel, MD, Principal Investigator, Orange County Research Center
    • Overall Contact(s)
      • Kemuel Reyes, 9083339379, Kemuel.Reyes@us.nestle.com

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