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

NCT ID: NCT00748696

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-12-31

Brief 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.

Detailed Description

Age-related sarcopenia is a common situation defined by muscle mass and function loss in an otherwise healthy elderly person. Epidemiological data from the USA show 49% of men and 72% of women to suffer from sarcopenia. Few data is available on the French population. Sarcopenia is associated with increased morbidity, mortality, disability and reduced resistance to metabolic stress. Resistance training and nutrition are two non-pharmaceutical methods that may be able to prevent several age-related condition.

The aim of this study is to assess the effects of resistance training, associated or not with oral nutritional supplements, on skeletal muscle mass (expressed as skeletal muscle mass index) 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.

We expect to show that sarcopenia can be improved by 12 weeks of resistance training and that this improvement can be potentialized by oral nutritional supplements (with a stimulation of the mTOR pathway), and that oral nutritional supplements alone will affect neither muscle mass nor function.

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

patient receiving oral nutrition supplement

Group Type: EXPERIMENTAL

Fortimel Extra®

Intervention Type: DIETARY_SUPPLEMENT

260kcal and 20g protein per day

3

resistance training

Group Type: EXPERIMENTAL

resistance training

Intervention Type: OTHER

3 sessions of resistance training per week

4

patients receiving resistance training and oral nutritional supplement

Group Type: EXPERIMENTAL

combined treatment

Intervention Type: OTHER

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

Interventions

Fortimel Extra®

260kcal and 20g protein per day

Intervention Type: DIETARY_SUPPLEMENT

resistance training

3 sessions of resistance training per week

Intervention Type: OTHER

combined treatment

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 70 and 80 years
• Stable weight (± 1 kg) during the last three months
• Informed consent signed
• Chronic cachectic condition: cancer, chronic respiratory failure, advanced organ failure, hyperthyroidism, rheumatoid arthritis, AIDS, type 1 diabetes
• Drugs affecting muscle mass (e.g. steroids)
• Condition (clinical or EKG) significantly affecting physical capacities and/or contra-indicating resistance training
• Habitual practice of resistance training
• Habitual intake of nutritional supplements
• Known coagulation disorders (for muscle biopsy)
• Known allergy to lidocaine (for muscle biopsy)

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephane Schneider, PU PH

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology

Locations

Department of gastroenterology, Department of Gerontology

Nice, , France

Countries

France

Other Identifiers

06-API-04

Identifier Type: -

Identifier Source: org_study_id