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Combined Effects of Resistance Training and Nutritional Supplements in the Treatment of Sarcopenia

NCT00748696 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2012-02-22

No results posted yet for this study

Summary

Age-related sarcopenia is associated with increased morbidity, mortality, disability and reduced resistance to metabolic stress. The aim of this study is to assess the effects of resistance training, associated or not with oral nutritional supplements, on skeletal muscle mass in sarcopenic subjects. This is a prospective randomised controlled single-centre study that will last two years, three months for a participant.

200 healthy elderly (70-80 years old) subjects will be screened for sarcopenia by dual energy X-ray absorptiometry. 128 sarcopenic subjects will be randomized into 4 groups:

* group 1: controls
* group 2: oral nutritional supplement (260 kcal and 20 g protein per day)
* group 3: resistance training (3 times per week)
* group 4: oral nutritional supplement + resistance training

Every subject will be assessed at the beginning and at the end of 12 weeks of intervention on:

* muscle mass (DXA)
* muscle function (dynamometers)
* hormonal (testosterone, GH, IGF-1, cortisol) and inflammatory (IL-6, TNF-alpha) profiles
* food intake. Ten subjects in group 4 will undergo a muscle biopsy (quadriceps) before and after the intervention in order to explore protein and mRNA levels of the mTOR pathway, which may be involved in sarcopenia.

Conditions

Interventions

DIETARY_SUPPLEMENT

Fortimel Extra®

260kcal and 20g protein per day

OTHER

resistance training

3 sessions of resistance training per week

OTHER

combined treatment

260kcal and 20g protein per day 3 sessions of resistance training per week

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Stephane Schneider, PU PH · Department of Gastroenterology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
70 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00748696 on ClinicalTrials.gov