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Metabolic Effect of High-protein Meals in Men (OPTI-PROT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maurice Beaumont, Nestle Research Center
ClinicalTrials.gov Identifier:
NCT00712010
First received: July 3, 2008
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

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 ]

Enrollment: 28
Study Start Date: July 2008
Study Completion Date: April 2011
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: High-protein meal replacement
Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Other Name: Meal replacement
Experimental: 2 Dietary Supplement: High-protein meal replacement
Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Other Name: Meal replacement
Experimental: 3 Dietary Supplement: High-protein meal replacement
Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Other Name: Meal replacement
Experimental: 4 Dietary Supplement: High-protein meal replacement
Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Other Name: Meal replacement
Experimental: 5 Dietary Supplement: High-protein meal replacement
Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Other Name: Meal replacement
Experimental: 6 Dietary Supplement: High-protein meal replacement
Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Other Name: Meal replacement
Experimental: 7 Dietary Supplement: High-protein meal replacement
Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Other Name: Meal replacement

  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

Locations
Switzerland
Nestle Research Center
Lausanne, Switzerland, 1000
Sponsors and Collaborators
Maurice Beaumont
Investigators
Principal Investigator: Etienne Pouteau, Ph.D. Nestlé
  More Information

No publications provided

Responsible Party: Maurice Beaumont, Senior Medical Officer, Nestle Research Center
ClinicalTrials.gov Identifier: NCT00712010     History of Changes
Other Study ID Numbers: 07.26.MET, Ethics-71/08
Study First Received: July 3, 2008
Last Updated: May 3, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Nestlé:
Glucose
Insulin
Healthy men

ClinicalTrials.gov processed this record on May 21, 2013