Metabolic Effect of High-protein Meals in Men (OPTI-PROT)
July 12, 2013 updated by: CDUadmin, Nestlé
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.
Study Overview
Status
Completed
Conditions
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
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Lausanne, Switzerland, 1000
- Nestec Clinical Development Unit / Metabolic Unit
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Whey protein native
Whey protein native versus the 6 other arms
|
Whey protein microgels versus the six other arms
versus the six other arms
versus the six other arms
versus the six other arms
versus the six other arms
versus the six other arms
|
|
EXPERIMENTAL: Whey protein microgels
Whey protein microgels versus the 6 other arms
|
versus the six other arms
versus the six other arms
versus the six other arms
versus the six other arms
versus the six other arms
Whey protein native against the 6 other arms
|
|
EXPERIMENTAL: Hydrolyzed whey protein
Hydrolyzed whey protein versus the 6 other arms
|
Whey protein microgels versus the six other arms
versus the six other arms
versus the six other arms
versus the six other arms
versus the six other arms
Whey protein native against the 6 other arms
|
|
EXPERIMENTAL: Casein native
Casein native versus the 6 other arms
|
Whey protein microgels versus the six other arms
versus the six other arms
versus the six other arms
versus the six other arms
versus the six other arms
Whey protein native against the 6 other arms
|
|
EXPERIMENTAL: Hydrolyzed casein
Hydrolyzed casein versus the 6 other arms
|
Whey protein microgels versus the six other arms
versus the six other arms
versus the six other arms
versus the six other arms
versus the six other arms
Whey protein native against the 6 other arms
|
|
EXPERIMENTAL: Total milk protein native
Total milk protein native versus the 6 other arms
|
Whey protein microgels versus the six other arms
versus the six other arms
versus the six other arms
versus the six other arms
versus the six other arms
Whey protein native against the 6 other arms
|
|
EXPERIMENTAL: Hydrolyzed milk protein
Hydrolyzed milk protein versus the 6 other arms
|
Whey protein microgels versus the six other arms
versus the six other arms
versus the six other arms
versus the six other arms
versus the six other arms
Whey protein native against the 6 other arms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
180 minutes
|
|
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.
|
180 minutes from baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids
Time Frame: 180 minutes
|
180 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Etienne Pouteau, Ph.D., Nestle
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (ACTUAL)
July 1, 2009
Study Completion (ACTUAL)
April 1, 2011
Study Registration Dates
First Submitted
July 3, 2008
First Submitted That Met QC Criteria
July 8, 2008
First Posted (ESTIMATE)
July 9, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
August 14, 2013
Last Update Submitted That Met QC Criteria
July 12, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07.26.MET
- Ethics: 71/08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.