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

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.

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 Overview

• Status: Completed
• Conditions: Dietary Supplement
• Intervention / Treatment: Dietary supplement: Whey Protein Micro Gel; Other: Water without Whey Protein.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Tustin, California, United States, 92780
      • Orange County Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma glucose	Plasma glucose at individual timepoints	0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes
Serum insulin	Serum insulin at individual timepoints	0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes
Plasma glucagon	Plasma glucagon at individual timepoints	0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes)
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.
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.
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.
Plasma GLP-1	Plasma GLP-1 (iAUC 0-1hour, tAUC 0-1hour)	-15, 0, 30, 60, 90, 120 minutes.
Plasma GIP	Plasma GIP (iAUC 0-1hour, tAUC 0-1hour)	-15, 0, 30, 60, 90, 120 minutes.
Serum triglycerides	Serum triglycerides (iAUC 0-1hour, tAUC 0-1hour)	-15, 0, 30, 60, 90, 120 minutes
Plasma ghrelin	Plasma ghrelin (iAUC 0-1hour, tAUC 0-1hour)	-15, 0, 30, 60, 90, 120 minutes
Plasma cholecystokinin	Plasma cholecystokinin (CCK) (iAUC 0-1hour, tAUC 0-1hour)	-15, 0, 30, 60, 90, 120 minutes
Plasma peptide	Plasma peptide-YY (PYY) (iAUC 0-1hour, tAUC 0-1hour)	-15, 0, 30, 60, 90, 120 minutes.

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Actual): October 26, 2020
• Study Completion (Actual): October 26, 2020

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 19.14.CLI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No