Metabolic Effect of High-protein Meals in Men

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Post-prandial Plasma Responses of Glucose Concentrations	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	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 Outcome Measures

Name	Time	Method
Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids	180 minutes

Locations (1): Nestec Clinical Development Unit / Metabolic Unit
🇨🇭
Lausanne, Switzerland
Nestec Clinical Development Unit / Metabolic Unit
🇨🇭Lausanne, Switzerland