Relationships Between Quality of Ageing and Age-related Degenerated Disease (Compalimage) (Compalimage)
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|ClinicalTrials.gov Identifier: NCT00862615|
Recruitment Status : Unknown
Verified September 2010 by University Hospital, Clermont-Ferrand.
Recruitment status was: Recruiting
First Posted : March 17, 2009
Last Update Posted : September 29, 2010
|Condition or disease||Intervention/treatment||Phase|
|Age-related Degenerated Disease||Other: Measurement of muscle protein synthesis using stable isotopes and muscle biopsies.||Not Applicable|
In order to explore the effect of a moderate chronic inflammation on skeletal muscle function and protein metabolism and on bone status, two groups of 16 subjects each will be selected according to their inflammatory status ie non-inflamed versus micro-inflamed. The volunteers will be sampled twice at week 0 and week 6 in order to quantify plasma concentration of C reactive protein (CRP) using the ultra sensitive assay. The subjects exhibiting CRP lower than 1 mg/l twice will be included in the non-inflamed group and the subjects exhibiting CRP higher than 3 and lower than 15 mg/l will be included in the micro-inflamed group.
During the two weeks before the metabolic studies dietary intakes, DEXA, muscle function, VO2 max and biomarkers of bone remodelling will be assessed. Volunteers will then be submitted to a diet controlled for its protein content, for 4 days (1 g protein/kg/day and 30 kcal/kg/day) before metabolic investigations. One day before, urine will be collected for metabolomics. On the day of metabolic investigations, after an overnight fast, blood samples will be collected for albumin, fibrinogen, inflammatory cytokine and adipokine determination. Then, the subjects will be perfused with L-[1-13C] leucine for 8 hours (post absorptive sate then post prandial satte) during which expired gas and blood samples will be taken, as well as 2 muscle biopsies. Isotopic enrichments in expired gas, in plasma cetoiscaproate and in free or protein-bound leucine in muscle will be measured to determine proteolysis and proteosynthesis rate of muscle proteins.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Chronic Micro-inflammation and Bone and Muscular Status in Elderly|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||July 2010|
|Estimated Study Completion Date :||January 2011|
- Other: Measurement of muscle protein synthesis using stable isotopes and muscle biopsies.
Measurement of muscle protein synthesis using stable isotopes and muscle biopsies.
Isotopes are :
(13C)bicarbonate (0.09 mg/kg fat-free mass) and L(1-13C)leucine (1.3 mg/kg fat-free mass) (intravenous way) L-(5,5,5 2H3) leucine(0.09 µmoles/(kg de fat-free mass.min) (oral way)
- Isotopic enrichments in expired gas, in plasma cetoisocaproate and in free or protein-bound leucine in muscle will be measured to determine proteolysis and proteosynthesis rate of muscle proteins. [ Time Frame: at week 0 and week 6 ]
- Splanchnic extraction of amino acids, bone metabolism, muscular strength, global metabolism and quality of life. [ Time Frame: at week 0 and week 6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862615
|Contact: Patrick Lacarinfirstname.lastname@example.org|
|Clermont-Ferrand, France, 63003|
|Contact: Patrick Lacarin 04.73.75.11.95 email@example.com|
|Principal Investigator:||Noël CANO||University Hospital, Clermont-Ferrand|
|Study Director:||Dominique Dardevet||Institut National de la Recherche Agronomique|