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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00712010
Recruitment Status : Completed
First Posted : July 9, 2008
Results First Posted : August 14, 2013
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):
CDUadmin, Nestlé

Tracking Information
First Submitted Date  ICMJE July 3, 2008
First Posted Date  ICMJE July 9, 2008
Results First Submitted Date  ICMJE April 9, 2013
Results First Posted Date  ICMJE August 14, 2013
Last Update Posted Date August 14, 2013
Study Start Date  ICMJE July 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2013)
  • Post-prandial Plasma Responses of Glucose Concentrations [ Time Frame: 180 minutes ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2008)
Post-prandial plasma responses of glucose and insulin concentrations [ Time Frame: 180 minutes ]
Change History Complete list of historical versions of study NCT00712010 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2008)
Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids [ Time Frame: 180 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metabolic Effect of High-protein Meals in Men
Official Title  ICMJE Acute Metabolic Effect of the Protein Quality of a High-protein Meal Replacement in Healthy Men
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 randomized order preferably a week apart. The 7 test meals were isocaloric, isonitrogenous and differed in their protein quality.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2013)
25
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2008)
28
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00712010
Other Study ID Numbers  ICMJE 07.26.MET
Ethics: 71/08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CDUadmin, Nestlé
Study Sponsor  ICMJE Nestlé
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Etienne Pouteau, Ph.D. Nestlé
PRS Account Nestlé
Verification Date July 2013

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