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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00748696
First received: September 4, 2008
Last updated: February 20, 2012
Last verified: June 2009
  Purpose

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.

Condition Intervention Phase
Sarcopenia
Dietary Supplement: Fortimel Extra®
Other: resistance training
Other: combined treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Effects of Resistance Training and Nutritional Supplements in the Treatment of Sarcopenia

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • muscle mass (DXA) [ Time Frame: D0 and after 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • muscle function (dynamometers), hormonal (testosterone, GH, IGF-1, cortisol) and inflammatory (IL-6, TNF-alpha) profiles, food intake, ± muscle biopsy. [ Time Frame: D0 and after 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: December 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
No intervention
Experimental: 2
patient receiving oral nutrition supplement
Dietary Supplement: Fortimel Extra®
260kcal and 20g protein per day
Experimental: 3
resistance training
Other: resistance training
3 sessions of resistance training per week
Experimental: 4
patients receiving resistance training and oral nutritional supplement
Other: combined treatment
260kcal and 20g protein per day 3 sessions of resistance training per week

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

Ages Eligible for Study:   70 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748696

Locations
France
Department of gastroenterology, Department of Gerontology
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Stephane Schneider, PU PH Department of Gastroenterology
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00748696     History of Changes
Other Study ID Numbers: 06-API-04
Study First Received: September 4, 2008
Last Updated: February 20, 2012
Health Authority: France: Direction Générale de la Santé
France: French Data Protection Authority
France: Institutional Ethical Committee
France: Ministry of Health

Keywords provided by Centre Hospitalier Universitaire de Nice:
sarcopenia
elderly
resistance training
oral nutritional supplement

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014