Metabolic Effect of High-Protein Meals in Men - Full Text View

Sponsored by:	Nestle Research Center
Information provided by:	Nestle Research Center
ClinicalTrials.gov Identifier:	NCT00712010

Purpose

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.

Condition	Intervention
Healthy	Dietary Supplement: High-protein meal replacement

Drug Information available for: Insulin Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study
Official Title:	Acute Metabolic Effect of the Protein Quality of a High-Protein Meal Replacement in Healthy Men

Further study details as provided by Nestle Research Center:

Primary Outcome Measures:

Post-prandial plasma responses of glucose and insulin concentrations [ Time Frame: 180 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Post-prandial plasma responses of glucagon, c-peptide, amino acids and lipids [ Time Frame: 180 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	28
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Dietary Supplement: High-protein meal replacement Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
2: Experimental	Dietary Supplement: High-protein meal replacement Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
3: Experimental	Dietary Supplement: High-protein meal replacement Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
4: Experimental	Dietary Supplement: High-protein meal replacement Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
5: Experimental	Dietary Supplement: High-protein meal replacement Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
6: Experimental	Dietary Supplement: High-protein meal replacement Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
7: Experimental	Dietary Supplement: High-protein meal replacement Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.

Eligibility

Ages Eligible for Study:	20 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

20 - 40 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 (ALAT, ASAT, 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712010

Contacts

Contact: Maurice Beaumont, M.D.

00 41 21 785 80 54

Locations

Switzerland
Nestle Research Center	Recruiting
Lausanne, Switzerland, 1000

Sponsors and Collaborators

Nestle Research Center

Investigators

Principal Investigator:

Etienne Pouteau, Ph.D.

Nestle Research Center

More Information

Responsible Party:	Nestle Research Center ( Dr Etienne Pouteau )
Study ID Numbers:	07.26.MET, Ethics-71/08
Study First Received:	July 3, 2008
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00712010
Health Authority:	Switzerland: Ethikkommission

Keywords provided by Nestle Research Center:

Glucose
Insulin
Healthy men

Study placed in the following topic categories:

Healthy
Insulin

ClinicalTrials.gov processed this record on January 14, 2009