Metabolic Effect of High-protein Meals in Men
OPTI-PROT
Acute Metabolic Effect of the Protein Quality of a High-protein Meal Replacement in Healthy Men
2 other identifiers
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Jul 2008
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 3, 2008
CompletedFirst Posted
Study publicly available on registry
July 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
August 14, 2013
CompletedAugust 14, 2013
July 1, 2013
1 year
July 3, 2008
April 9, 2013
July 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Post-prandial Plasma Responses of Glucose Concentrations
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
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 Outcomes (1)
Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids
180 minutes
Study Arms (7)
Whey protein native
EXPERIMENTALWhey protein native versus the 6 other arms
Whey protein microgels
EXPERIMENTALWhey protein microgels versus the 6 other arms
Hydrolyzed whey protein
EXPERIMENTALHydrolyzed whey protein versus the 6 other arms
Casein native
EXPERIMENTALCasein native versus the 6 other arms
Hydrolyzed casein
EXPERIMENTALHydrolyzed casein versus the 6 other arms
Total milk protein native
EXPERIMENTALTotal milk protein native versus the 6 other arms
Hydrolyzed milk protein
EXPERIMENTALHydrolyzed milk protein versus the 6 other arms
Interventions
Whey protein native against 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nestec Clinical Development Unit / Metabolic Unit
Lausanne, 1000, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Maurice Beaumont
- Organization
- Clinical Development Unit / Metabolic Unit
Study Officials
- STUDY DIRECTOR
Etienne Pouteau, Ph.D.
Société des Produits Nestlé (SPN)
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 3, 2008
First Posted
July 9, 2008
Study Start
July 1, 2008
Primary Completion
July 1, 2009
Study Completion
April 1, 2011
Last Updated
August 14, 2013
Results First Posted
August 14, 2013
Record last verified: 2013-07