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

Centre Hospitalier Universitaire de Nice

Status and phase: Terminated; Phase 3

Conditions: Sarcopenia

Treatments: Other: combined treatment; Dietary Supplement: Fortimel Extra®; Other: resistance training

Study type: Interventional

Funder types: Other

Identifiers

NCT00748696

06-API-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 70 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age between 70 and 80 years
• Stable weight (± 1 kg) during the last three months
• Informed consent signed
• Affiliated with the French Sécurité Sociale Non-inclusion criteria
• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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2 participants in 4 patient groups

1

No Intervention group

Description:

No intervention

2

Experimental group

Description:

patient receiving oral nutrition supplement

Treatment:

Dietary Supplement: Fortimel Extra®

3

Experimental group

Description:

resistance training

Treatment:

Other: resistance training

4

Experimental group

Description:

patients receiving resistance training and oral nutritional supplement

Treatment:

Other: combined treatment