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
  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
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

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:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • 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.


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: 25
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: 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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712010

Locations
Switzerland
Nestec Clinical Development Unit / Metabolic Unit
Lausanne, Switzerland, 1000
Sponsors and Collaborators
Nestlé
Investigators
Study Director: Etienne Pouteau, Ph.D. Nestlé
  More Information

No publications provided

Responsible Party: CDUadmin, Principal Investigator, Nestlé
ClinicalTrials.gov Identifier: NCT00712010     History of Changes
Other Study ID Numbers: 07.26.MET, Ethics: 71/08
Study First Received: July 3, 2008
Results First Received: April 9, 2013
Last Updated: July 12, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by Nestlé:
Glucose
Insulin

Additional relevant MeSH terms:
Caseins
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014