Metabolic Effect of High-protein Meals in Men

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acute Metabolic Effect of the Protein Quality of a High-protein Meal Replacement in Healthy Men

Conditions
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Healthy

Intervention / Treatment
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* Other: Whey protein native
* Other: Whey protein microgels
* Other: Hydrolyzed whey protein
* Other: Casein native
* Other: Hydrolyzed casein
* Other: Total milk protein native
* Other: Hydrolyzed milk protein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whey protein native<br>Whey protein native versus the 6 other arms | Other: Whey protein microgels<br>* Whey protein microgels versus the six other arms<br>Other: Hydrolyzed whey protein<br>* versus the six other arms<br>Other: Casein native<br>* versus the six other arms<br>Other: Hydrolyzed casein<br>* versus the six other arms<br>Other: Total milk protein native<br>* versus the six other arms<br>Other: Hydrolyzed milk protein<br>* versus the six other arms<br>|
| Experimental: Whey protein microgels<br>Whey protein microgels versus the 6 other arms | Other: Whey protein native<br>* Whey protein native against the 6 other arms<br>Other: Hydrolyzed whey protein<br>* versus the six other arms<br>Other: Casein native<br>* versus the six other arms<br>Other: Hydrolyzed casein<br>* versus the six other arms<br>Other: Total milk protein native<br>* versus the six other arms<br>Other: Hydrolyzed milk protein<br>* versus the six other arms<br>|
| Experimental: Hydrolyzed whey protein<br>Hydrolyzed whey protein versus the 6 other arms | Other: Whey protein native<br>* Whey protein native against the 6 other arms<br>Other: Whey protein microgels<br>* Whey protein microgels versus the six other arms<br>Other: Casein native<br>* versus the six other arms<br>Other: Hydrolyzed casein<br>* versus the six other arms<br>Other: Total milk protein native<br>* versus the six other arms<br>Other: Hydrolyzed milk protein<br>* versus the six other arms<br>|
| Experimental: Casein native<br>Casein native versus the 6 other arms | Other: Whey protein native<br>* Whey protein native against the 6 other arms<br>Other: Whey protein microgels<br>* Whey protein microgels versus the six other arms<br>Other: Hydrolyzed whey protein<br>* versus the six other arms<br>Other: Hydrolyzed casein<br>* versus the six other arms<br>Other: Total milk protein native<br>* versus the six other arms<br>Other: Hydrolyzed milk protein<br>* versus the six other arms<br>|
| Experimental: Hydrolyzed casein<br>Hydrolyzed casein versus the 6 other arms | Other: Whey protein native<br>* Whey protein native against the 6 other arms<br>Other: Whey protein microgels<br>* Whey protein microgels versus the six other arms<br>Other: Hydrolyzed whey protein<br>* versus the six other arms<br>Other: Casein native<br>* versus the six other arms<br>Other: Total milk protein native<br>* versus the six other arms<br>Other: Hydrolyzed milk protein<br>* versus the six other arms<br>|
| Experimental: Total milk protein native<br>Total milk protein native versus the 6 other arms | Other: Whey protein native<br>* Whey protein native against the 6 other arms<br>Other: Whey protein microgels<br>* Whey protein microgels versus the six other arms<br>Other: Hydrolyzed whey protein<br>* versus the six other arms<br>Other: Casein native<br>* versus the six other arms<br>Other: Hydrolyzed casein<br>* versus the six other arms<br>Other: Hydrolyzed milk protein<br>* versus the six other arms<br>|
| Experimental: Hydrolyzed milk protein<br>Hydrolyzed milk protein versus the 6 other arms | Other: Whey protein native<br>* Whey protein native against the 6 other arms<br>Other: Whey protein microgels<br>* Whey protein microgels versus the six other arms<br>Other: Hydrolyzed whey protein<br>* versus the six other arms<br>Other: Casein native<br>* versus the six other arms<br>Other: Hydrolyzed casein<br>* versus the six other arms<br>Other: Total milk protein native<br>* versus the six other arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial Plasma Responses of Glucose Concentrations | 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. | 180 minutes | 
| Calculation of the Area Under Curve Over Baseline for Plasma Insulin | 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. | 180 minutes from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids |  | 180 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose, Insulin