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Relationships Between Quality of Ageing and Age-related Degenerated Disease (Compalimage)

NCT ID: NCT00862615

Last Updated: 2010-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-01-31

Brief Summary

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This project aims to assess the impact of chronic micro-inflammation on age-related loss of muscle (sarcopenia) and bone (osteopenia). The hypothesis is that chronic micro-inflammation and oxidative stress, which prevalence increases during ageing, may participate in the pathogenesis of both sarcopenia and osteopenia.

Detailed Description

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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.

Conditions

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Age-related Degenerated Disease

Keywords

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Ageing Inflammation Muscle protein synthesis Osteopenia Sarcopenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male
* Body mass index 21 BMI 30 kg/m2
* Affiliated to National Health Insurance
* Subject giving his written informed consent
* Subject considered as normal after clinical examination and medical questionnaire.

Exclusion Criteria

* Positive serologies to HIV or HCV, determined on blood samples
* Previous medical and/or surgery judged by the investigator as incompatible with this study
* Chronic pathologies : Diabetes, cardiovascular diseases, cancer, chronic inflammation diseases, renal, pulmonary impairments Reported xylocaïne allergy
* Osteoporosis
* Prostate hypertrophy
* Glaucoma
* Heavy consumer of alcohol
* Practising intensive physical exercise
* Being under someone's supervision
* Refusal to be registered on the National Volunteers Data file
* Dietary habits unreliable to controlled food intake
* Being in exclusion on the National Volunteers Data file
Minimum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre de Recherche en Nutrition Humaine d'Auvergne

OTHER_GOV

Sponsor Role collaborator

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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CHU Clermont-Ferrand

Principal Investigators

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Noël CANO

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Dominique Dardevet

Role: STUDY_DIRECTOR

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick Lacarin

Role: CONTACT

Phone: 04.73.75.11.95

Email: [email protected]

Facility Contacts

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Patrick Lacarin

Role: primary

Other Identifiers

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IDRCB 2008-A00593-52

Identifier Type: -

Identifier Source: secondary_id

AU750

Identifier Type: -

Identifier Source: secondary_id

CHU-0048

Identifier Type: -

Identifier Source: org_study_id