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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CDUadmin, Nestlé
ClinicalTrials.gov Identifier:
NCT00712010
First received: July 3, 2008
Last updated: July 12, 2013
Last verified: July 2013

July 3, 2008
July 12, 2013
July 2008
July 2009   (final data collection date for primary outcome measure)
  • Post-prandial Plasma Responses of Glucose Concentrations [ Time Frame: 180 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 180 minutes from baseline ] [ Designated as safety issue: No ]
    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.
Post-prandial plasma responses of glucose and insulin concentrations [ Time Frame: 180 minutes ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00712010 on ClinicalTrials.gov Archive Site
Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids [ Time Frame: 180 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Metabolic Effect of High-protein Meals in Men
Acute Metabolic Effect of the Protein Quality of a High-protein Meal Replacement in Healthy Men

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
  • Other: Whey protein native
    Whey protein native against the 6 other arms
  • Other: Whey protein microgels
    Whey protein microgels versus the six other arms
  • Other: Hydrolyzed whey protein
    versus the six other arms
  • Other: Casein native
    versus the six other arms
  • Other: Hydrolyzed casein
    versus the six other arms
  • Other: Total milk protein native
    versus the six other arms
  • Other: Hydrolyzed milk protein
    versus the six other arms
  • Experimental: Whey protein native
    Whey protein native versus the 6 other arms
    Interventions:
    • Other: Whey protein microgels
    • Other: Hydrolyzed whey protein
    • Other: Casein native
    • Other: Hydrolyzed casein
    • Other: Total milk protein native
    • Other: Hydrolyzed milk protein
  • Experimental: Whey protein microgels
    Whey protein microgels versus the 6 other arms
    Interventions:
    • Other: Whey protein native
    • Other: Hydrolyzed whey protein
    • Other: Casein native
    • Other: Hydrolyzed casein
    • Other: Total milk protein native
    • Other: Hydrolyzed milk protein
  • Experimental: Hydrolyzed whey protein
    Hydrolyzed whey protein versus the 6 other arms
    Interventions:
    • Other: Whey protein native
    • Other: Whey protein microgels
    • Other: Casein native
    • Other: Hydrolyzed casein
    • Other: Total milk protein native
    • Other: Hydrolyzed milk protein
  • Experimental: Casein native
    Casein native versus the 6 other arms
    Interventions:
    • Other: Whey protein native
    • Other: Whey protein microgels
    • Other: Hydrolyzed whey protein
    • Other: Hydrolyzed casein
    • Other: Total milk protein native
    • Other: Hydrolyzed milk protein
  • Experimental: Hydrolyzed casein
    Hydrolyzed casein versus the 6 other arms
    Interventions:
    • Other: Whey protein native
    • Other: Whey protein microgels
    • Other: Hydrolyzed whey protein
    • Other: Casein native
    • Other: Total milk protein native
    • Other: Hydrolyzed milk protein
  • Experimental: Total milk protein native
    Total milk protein native versus the 6 other arms
    Interventions:
    • Other: Whey protein native
    • Other: Whey protein microgels
    • Other: Hydrolyzed whey protein
    • Other: Casein native
    • Other: Hydrolyzed casein
    • Other: Hydrolyzed milk protein
  • Experimental: Hydrolyzed milk protein
    Hydrolyzed milk protein versus the 6 other arms
    Interventions:
    • Other: Whey protein native
    • Other: Whey protein microgels
    • Other: Hydrolyzed whey protein
    • Other: Casein native
    • Other: Hydrolyzed casein
    • Other: Total milk protein native
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
April 2011
July 2009   (final data collection date for primary outcome measure)

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
Male
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00712010
07.26.MET, Ethics: 71/08
No
CDUadmin, Nestlé
Nestlé
Not Provided
Study Director: Etienne Pouteau, Ph.D. Nestlé
Nestlé
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP