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

February 20, 2012 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

2

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • Department of gastroenterology, Department of Gerontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 80 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
muscle mass (DXA)
Time Frame: D0 and after 12 weeks
D0 and after 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
D0 and after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Stephane Schneider, PU PH, Department of Gastroenterology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

September 4, 2008

First Submitted That Met QC Criteria

September 4, 2008

First Posted (ESTIMATE)

September 8, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 20, 2012

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-API-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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