Clinical trial NCT04639726: A Study to Evaluate the Effects of Pre-Meal Whey Protein Microgels Administration on Post-Prandial Glycemic Response.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Supplement
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2020-11-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Post-prandial glycemic excursion.
timeFrame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Secondary outcomes:
measure: 2h post-prandial glucose
timeFrame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
measure: Total glucose
timeFrame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
measure: Plasma glucose
timeFrame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
measure: Plasma glucose
timeFrame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
measure: Plasma glucose
timeFrame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
measure: Serum insulin
timeFrame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
measure: Plasma glucagon
timeFrame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
measure: Plasma Glucagon-like Peptide-1
timeFrame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
measure: Plasma Gastric Inhibitory Polypeptide
timeFrame: -15, 0, 30, 60, 90, and 120 minutes.
measure: Plasma ghrelin
timeFrame: -15, 0, 30, 60, 90, and 120 minutes.
measure: Plasma cholecystokinin
timeFrame: -15, 0, 30, 60, 90, and 120 minutes.
measure: Plasma peptide
timeFrame: -15, 0, 30, 60, 90, and 120 minutes.
measure: Serum triglycerides
timeFrame: -15, 0, 30, 60, 90, and 120 minutes.
measure: Gastric emptying
timeFrame: -15, 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes.
measure: Beta-cell function I
timeFrame: -15, 0, 30, 60, 90, and 120 minutes.
measure: Beta-cell function II
timeFrame: -15, 0, 30, 60, 90, and 120 minutes.
Other outcomes:
measure: Plasma glucose
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes
measure: Serum insulin
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes
measure: Plasma glucagon
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes)
measure: Plasma glucose
timeFrame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
measure: Serum insulin
timeFrame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
measure: Plasma glucagon
timeFrame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
measure: Plasma GLP-1
timeFrame: -15, 0, 30, 60, 90, 120 minutes.
measure: Plasma GIP
timeFrame: -15, 0, 30, 60, 90, 120 minutes.
measure: Serum triglycerides
timeFrame: -15, 0, 30, 60, 90, 120 minutes
measure: Plasma ghrelin
timeFrame: -15, 0, 30, 60, 90, 120 minutes
measure: Plasma cholecystokinin
timeFrame: -15, 0, 30, 60, 90, 120 minutes
measure: Plasma peptide
timeFrame: -15, 0, 30, 60, 90, 120 minutes.
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
Study officials:
affiliation: Orange County Research Center
name: Joel M Neutel, MD
role: PRINCIPAL_INVESTIGATOR
References: