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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04639726
Other study ID # 19.14.CLI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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