Clinical trial NCT00748696: Combined Effects of Resistance Training and Nutritional Supplements in the Treatment of Sarcopenia
Official title: Combined Effects of Resistance Training and Nutritional Supplements in the Treatment of Sarcopenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Sarcopenia
Keywords: sarcopenia
elderly
resistance training
oral nutritional supplement
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2008-09-08
Enrollment: 2
Sex: ALL
Minimum age (years): 70
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: muscle mass (DXA)
timeFrame: D0 and after 12 weeks
Secondary outcomes:
measure: muscle function (dynamometers), hormonal (testosterone, GH, IGF-1, cortisol) and inflammatory (IL-6, TNF-alpha) profiles, food intake, ± muscle biopsy.
timeFrame: D0 and after 12 weeks
Other outcomes:
Locations:
city: Nice
country: France
facility: Department of gastroenterology, Department of Gerontology
Study officials:
affiliation: Department of Gastroenterology
name: Stephane Schneider, PU PH
role: PRINCIPAL_INVESTIGATOR
References: