Acute Metabolic Effect of the Protein Quality of a High-protein Meal Replacement in Healthy Men
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Post-prandial Plasma Responses of Glucose Concentrations
Study Overview
Brief Summary
The purpose of the clinical study is to investigate the effect of the protein quality of high-protein meal replacements on the management of post-prandial blood glucose in healthy men.
Detailed Description
It was a double-blind, single center, randomized, crossover adaptive study design with 7 arms.
The subjects were submitted to 7 tests of ingestion of a high-protein meal replacement (test meal) in randomized order preferably a week apart. The 7 test meals were isocaloric, isonitrogenous and differed in their protein quality.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •20 - 50 years, male
- •Healthy as determined by a medical questionnaire
- •Normal weight: BMI 20 - 24.9 kg.m-2
- •Normal fasting glycemia and insulinemia
- •Normal fasting lipidemia (cholesterol and triglycerides)
- •Normal liver function (transaminases, γ-GT) and kidney function (urea, creatinine)
- •Capable of fast ingestion of the meal replacement (5-10 min)
- •Having signed informed consent
Exclusion Criteria
- •Intestinal or metabolic diseases/disorders such as diabetic, renal, dyslipidemia, hepatic, hypertension, pancreatic or ulcer, including lacto-intolerance.
- •Hypertension >150/95 mmHg
- •Have had a gastrointestinal surgery
- •Have a regular consumption of medication
- •Vegetarian, vegan, under dietary supplements
- •Have an alcohol intake: > 2 units a day or smoker
- •Currently participating or having participated in a clinical trial during the last month
- •Having given blood in the last month
- •More than 5 x 45 min of intense exercise per week
- •Volunteer who cannot be expected to comply with treatment
Outcomes
Primary Outcomes
Post-prandial Plasma Responses of Glucose Concentrations
Time Frame: 180 minutes
The concentrations of glucose were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.
Calculation of the Area Under Curve Over Baseline for Plasma Insulin
Time Frame: 180 minutes from baseline
The concentrations of insulin were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.
Secondary Outcomes
- Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids(180 minutes)
Investigators
CDUadmin
Principal Investigator
Société des Produits Nestlé (SPN)