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

Dietary Supplement Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04639726
• Other study ID #: 19.14.CLI
• Status: Completed
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: October 26, 2020

Study information

• Verified date: October 2020
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 26, 2020
• Est. primary completion date: October 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Supplement

Intervention

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.

Locations

Country	Name	City	State
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma glucose	Plasma glucose at individual timepoints	0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes
Other	Serum insulin	Serum insulin at individual timepoints	0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes
Other	Plasma glucagon	Plasma glucagon at individual timepoints	0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes)
Other	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.
Other	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.
Other	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.
Other	Plasma GLP-1	Plasma GLP-1 (iAUC 0-1hour, tAUC 0-1hour)	-15, 0, 30, 60, 90, 120 minutes.
Other	Plasma GIP	Plasma GIP (iAUC 0-1hour, tAUC 0-1hour)	-15, 0, 30, 60, 90, 120 minutes.
Other	Serum triglycerides	Serum triglycerides (iAUC 0-1hour, tAUC 0-1hour)	-15, 0, 30, 60, 90, 120 minutes
Other	Plasma ghrelin	Plasma ghrelin (iAUC 0-1hour, tAUC 0-1hour)	-15, 0, 30, 60, 90, 120 minutes
Other	Plasma cholecystokinin	Plasma cholecystokinin (CCK) (iAUC 0-1hour, tAUC 0-1hour)	-15, 0, 30, 60, 90, 120 minutes
Other	Plasma peptide	Plasma peptide-YY (PYY) (iAUC 0-1hour, tAUC 0-1hour)	-15, 0, 30, 60, 90, 120 minutes.
Primary	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	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.
Secondary	Total glucose	Total glucose AUC (tAUC 0-3hours)	-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Secondary	Plasma glucose	Plasma glucose iCmax	-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Secondary	Plasma glucose	Plasma glucose Tmax	-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Secondary	Plasma glucose	Plasma glucose AUC (iAUC 0-4hours, tAUC 0-4hours)	-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Plasma Gastric Inhibitory Polypeptide	Plasma GIP (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)	-15, 0, 30, 60, 90, and 120 minutes.
Secondary	Plasma ghrelin	Plasma ghrelin (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)	-15, 0, 30, 60, 90, and 120 minutes.
Secondary	Plasma cholecystokinin	Plasma cholecystokinin (CCK) (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)	-15, 0, 30, 60, 90, and 120 minutes.
Secondary	Plasma peptide	Plasma peptide-YY (PYY) (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)	-15, 0, 30, 60, 90, and 120 minutes.
Secondary	Serum triglycerides	Serum triglycerides (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)	-15, 0, 30, 60, 90, and 120 minutes.
Secondary	Gastric emptying	Gastric emptying (AUC 0-4hours, Cmax and Tmax for acetaminophen)	-15, 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes.
Secondary	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.
Secondary	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.