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

NCT ID: NCT04639726

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2020-10-26

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.

Conditions

Dietary Supplement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Whey Protein

Group Type: ACTIVE_COMPARATOR

Whey Protein Micro Gel

Intervention Type: DIETARY_SUPPLEMENT

The test product is whey protein microgels 10g, reconstituted in 125ml water.

Placebo

Group Type: PLACEBO_COMPARATOR

Water without Whey Protein.

Intervention Type: OTHER

A matching placebo (125ml of water without whey protein) will be used as control.

Interventions

Whey Protein Micro Gel

The test product is whey protein microgels 10g, reconstituted in 125ml water.

Intervention Type: DIETARY_SUPPLEMENT

Water without Whey Protein.

A matching placebo (125ml of water without whey protein) will be used as control.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joel M Neutel, MD

Role: PRINCIPAL_INVESTIGATOR

Orange County Research Center

Locations

Orange County Research Center

Tustin, California, United States

Countries

United States

Other Identifiers

19.14.CLI

Identifier Type: -

Identifier Source: org_study_id