- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02157805
Technological Processes on Quality of Meat
Effect of Technological Processes on Nutritional Quality of Meat Proteins
Study Overview
Detailed Description
Beef meat, whose proteins were intrinsically labelled with 15 N, was previously obtained by infusing 15N ammonium sulphate during 50 days in the rumen of an heifer. Two different cooking conditions have been applied to this meat (5 min at 55°C vs 30 min at 90°C). Ten healthy elderly volunteers will test each processed meat according to a cross-over design, during 2 different metabolic studies separated by at least 2 weeks. Volunteers will be submitted to a diet controlled for its protein content, for 4 days (1.2 g protein/kg/day) before each metabolic investigation.
On the 2 days of metabolic investigations, after an overnight fast, blood samples will be collected for basal measurements. Then the subjects will be perfused with L-[1-13C] leucine for 9h30 hours, during which expired gas and blood samples will be regularly taken, and CO2 production measured. The volunteers will be asked to eat a 130 g beef meat 2.5h after the onset of the perfusion. Isotopic enrichments in expired gas, in plasma alpha-cetoiscaproate and in free leucine will be measured to determine whole body amino acids fluxes (oxidation, protein synthesis and proteolysis). 15N enrichments of leucine will allow splanchnic extraction measurement.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Auvergne
-
Clermont-Ferrand, Auvergne, France, 63000
- Centre de Recherche en Nutrition Humaine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria :
- Male
- Age > 70
- Body mass index 21 < BMI < 28 kg/m2
- Affiliated to National Health Insurance
- Subject giving his written informed consent
- Subject considered as normal after clinical and medical examinations
Exclusion Criteria :
- Positive serologies to HIV or HCV, or abnormal laboratory tests
- Previous medical and/or surgery judged by the investigator as incompatible with this study
- Person who doesn't eat beef or only if prepared according to religious rite
- Person wearing a removable denture or suffering of dry mouth syndrome
- Regular medication with glucocorticoids
- Intense sports activity > 7h/week
- Heavy alcohol consumption
- Being under someone's supervision
- Refusal to be registered on the National Volunteers Data file
- Being in exclusion on the National Volunteers Data file
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: rare beef meat
beef meat cooked during 5 minutes at 55°C
|
Meat cooking conditions
|
Active Comparator: well cook beef meat
beef meat cooked during 30 minutes à 90°C
|
Meat cooking conditions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma amino acids concentrations before and during 7 hours after eating labelled meat.
Time Frame: up to 7 hours
|
Plasma amino acids concentrations before and during 7 hours after eating labelled meat. Splanchnic extraction of leucine. Isotopic enrichments in expired gas, in plasma alpha-cetoisocaproate and in free leucine to determine whole body protein metabolism |
up to 7 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in plasma peptidome after ingestion of a meat meal
Time Frame: up to 7 hours
|
up to 7 hours
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yves Boirie, Md-PhD, Institut National de la Recherche Agronomique
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AU1024
- 2013-A00020-45 (Registry Identifier: IDRCB number)
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.
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