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

NCT04639726 | Completed

• 1 other identifier: 19.14.CLI
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 2h post-prandial glucose

  -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.

• Total glucose

  -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.

• Plasma glucose

  -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.

• Plasma glucose

  -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.

• Plasma glucose

  -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.

Other Outcomes (12)

• Plasma glucose

  0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes

• Serum insulin

  0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes

• Plasma glucagon

  0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes)

Study Arms (2)

Whey Protein

ACTIVE COMPARATOR

Dietary Supplement: Whey Protein Micro Gel

Placebo

PLACEBO COMPARATOR

Other: Water without Whey Protein.

Interventions

Whey Protein Micro Gel DIETARY_SUPPLEMENT

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

Whey Protein

Water without Whey Protein. OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Orange County Research Center

Tustin, California, 92780, United States

Location

MeSH Terms

Interventions

Water; Whey Proteins

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Joel M Neutel, MD

  Orange County Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 20, 2020
• Study Start: September 28, 2020
• Primary Completion: October 26, 2020
• Study Completion: October 26, 2020
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)