We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00748696
Recruitment Status : Terminated
First Posted : September 8, 2008
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.

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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Effects of Resistance Training and Nutritional Supplements in the Treatment of Sarcopenia
Study Start Date : December 2006
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. muscle mass (DXA) [ Time Frame: D0 and after 12 weeks ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years to 80 Years   (Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00748696     History of Changes
Other Study ID Numbers: 06-API-04
First Posted: September 8, 2008    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: June 2009

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