Metabolic Effect of High-protein Meals in Men

Not Applicable

Completed

Conditions: Healthy

Interventions: Other: Whey protein microgels
Other: Whey protein native
Other: Hydrolyzed whey protein
Other: Casein native
Other: Hydrolyzed casein
Other: Total milk protein native
Other: Hydrolyzed milk protein

Registration Number: NCT00712010

Lead Sponsor: Société des Produits Nestlé (SPN)

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

Status: COMPLETED

Sex: Male

Target Recruitment: 25

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Whey protein microgels	Hydrolyzed whey protein	Whey protein microgels versus the 6 other arms
Whey protein native	Hydrolyzed whey protein	Whey protein native versus the 6 other arms
Whey protein native	Total milk protein native	Whey protein native versus the 6 other arms
Whey protein native	Casein native	Whey protein native versus the 6 other arms
Whey protein native	Hydrolyzed casein	Whey protein native versus the 6 other arms
Whey protein native	Whey protein microgels	Whey protein native versus the 6 other arms
Whey protein native	Hydrolyzed milk protein	Whey protein native versus the 6 other arms
Whey protein microgels	Whey protein native	Whey protein microgels versus the 6 other arms
Whey protein microgels	Casein native	Whey protein microgels versus the 6 other arms
Whey protein microgels	Hydrolyzed casein	Whey protein microgels versus the 6 other arms
Whey protein microgels	Total milk protein native	Whey protein microgels versus the 6 other arms
Whey protein microgels	Hydrolyzed milk protein	Whey protein microgels versus the 6 other arms
Hydrolyzed whey protein	Whey protein native	Hydrolyzed whey protein versus the 6 other arms
Hydrolyzed whey protein	Whey protein microgels	Hydrolyzed whey protein versus the 6 other arms
Hydrolyzed whey protein	Casein native	Hydrolyzed whey protein versus the 6 other arms
Hydrolyzed whey protein	Hydrolyzed casein	Hydrolyzed whey protein versus the 6 other arms
Hydrolyzed whey protein	Total milk protein native	Hydrolyzed whey protein versus the 6 other arms
Hydrolyzed whey protein	Hydrolyzed milk protein	Hydrolyzed whey protein versus the 6 other arms
Casein native	Whey protein native	Casein native versus the 6 other arms
Casein native	Whey protein microgels	Casein native versus the 6 other arms
Casein native	Hydrolyzed whey protein	Casein native versus the 6 other arms
Casein native	Hydrolyzed casein	Casein native versus the 6 other arms
Casein native	Total milk protein native	Casein native versus the 6 other arms
Casein native	Hydrolyzed milk protein	Casein native versus the 6 other arms
Hydrolyzed casein	Whey protein native	Hydrolyzed casein versus the 6 other arms
Hydrolyzed casein	Whey protein microgels	Hydrolyzed casein versus the 6 other arms
Hydrolyzed casein	Hydrolyzed whey protein	Hydrolyzed casein versus the 6 other arms
Hydrolyzed casein	Casein native	Hydrolyzed casein versus the 6 other arms
Hydrolyzed casein	Total milk protein native	Hydrolyzed casein versus the 6 other arms
Hydrolyzed casein	Hydrolyzed milk protein	Hydrolyzed casein versus the 6 other arms
Total milk protein native	Whey protein native	Total milk protein native versus the 6 other arms
Total milk protein native	Whey protein microgels	Total milk protein native versus the 6 other arms
Total milk protein native	Hydrolyzed whey protein	Total milk protein native versus the 6 other arms
Total milk protein native	Casein native	Total milk protein native versus the 6 other arms
Total milk protein native	Hydrolyzed casein	Total milk protein native versus the 6 other arms
Total milk protein native	Hydrolyzed milk protein	Total milk protein native versus the 6 other arms
Hydrolyzed milk protein	Whey protein native	Hydrolyzed milk protein versus the 6 other arms
Hydrolyzed milk protein	Whey protein microgels	Hydrolyzed milk protein versus the 6 other arms
Hydrolyzed milk protein	Hydrolyzed whey protein	Hydrolyzed milk protein versus the 6 other arms
Hydrolyzed milk protein	Casein native	Hydrolyzed milk protein versus the 6 other arms
Hydrolyzed milk protein	Hydrolyzed casein	Hydrolyzed milk protein versus the 6 other arms
Hydrolyzed milk protein	Total milk protein native	Hydrolyzed milk protein versus the 6 other arms

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