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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Other: Whey protein native Other: Whey protein microgels Other: Hydrolyzed whey protein Other: Casein native Other: Hydrolyzed casein Other: Total milk protein native Other: Hydrolyzed milk protein Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : April 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: Whey protein native
Whey protein native versus 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 microgels
Whey protein microgels versus the 6 other arms
 Other: Whey protein native
Whey protein native against the 6 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: Hydrolyzed whey protein
Hydrolyzed whey protein versus the 6 other arms
 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: 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: Casein native
Casein native versus the 6 other arms
 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: 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: Hydrolyzed casein
Hydrolyzed casein versus the 6 other arms
 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: Total milk protein native
versus the six other arms

Other: Hydrolyzed milk protein
versus the six other arms
Experimental: Total milk protein native
Total milk protein native versus the 6 other arms
 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: Hydrolyzed milk protein
versus the six other arms
Experimental: Hydrolyzed milk protein
Hydrolyzed milk protein versus the 6 other arms
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids [ Time Frame: 180 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712010


Locations
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Switzerland
Nestec Clinical Development Unit / Metabolic Unit
Lausanne, Switzerland, 1000
Sponsors and Collaborators
Nestlé
Investigators
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Study Director: Etienne Pouteau, Ph.D. Nestlé
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: CDUadmin, Principal Investigator, Nestlé
ClinicalTrials.gov Identifier: NCT00712010    
Other Study ID Numbers: 07.26.MET
Ethics: 71/08
First Posted: July 9, 2008    Key Record Dates
Results First Posted: August 14, 2013
Last Update Posted: August 14, 2013
Last Verified: July 2013
Keywords provided by CDUadmin, Nestlé:
Glucose
Insulin
Additional relevant MeSH terms:
Layout table for MeSH terms
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action