Status:
COMPLETED
Metabolic Effect of High-protein Meals in Men
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Healthy
Eligibility:
MALE
20-50 years
Phase:
NA
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 ra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00712010
Start Date
July 1 2008
End Date
April 1 2011
Last Update
August 14 2013
Active Locations (1)
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1
Nestec Clinical Development Unit / Metabolic Unit
Lausanne, Switzerland, 1000