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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014