Combined Effects of Resistance Training and Nutritional Supplements in the Treatment of Sarcopenia
Primary Purpose
Sarcopenia
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Fortimel Extra®
resistance training
combined treatment
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia focused on measuring sarcopenia, elderly, resistance training, oral nutritional supplement
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)
Sites / Locations
- Department of gastroenterology, Department of Gerontology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
No intervention
patient receiving oral nutrition supplement
resistance training
patients receiving resistance training and oral nutritional supplement
Outcomes
Primary Outcome Measures
muscle mass (DXA)
Secondary Outcome Measures
muscle function (dynamometers), hormonal (testosterone, GH, IGF-1, cortisol) and inflammatory (IL-6, TNF-alpha) profiles, food intake, ± muscle biopsy.
Full Information
NCT ID
NCT00748696
First Posted
September 4, 2008
Last Updated
February 20, 2012
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT00748696
Brief Title
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
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Terminated
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
sarcopenia, elderly, resistance training, oral nutritional supplement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
2
Arm Type
Experimental
Arm Description
patient receiving oral nutrition supplement
Arm Title
3
Arm Type
Experimental
Arm Description
resistance training
Arm Title
4
Arm Type
Experimental
Arm Description
patients receiving resistance training and oral nutritional supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Fortimel Extra®
Intervention Description
260kcal and 20g protein per day
Intervention Type
Other
Intervention Name(s)
resistance training
Intervention Description
3 sessions of resistance training per week
Intervention Type
Other
Intervention Name(s)
combined treatment
Intervention Description
260kcal and 20g protein per day 3 sessions of resistance training per week
Primary Outcome Measure Information:
Title
muscle mass (DXA)
Time Frame
D0 and after 12 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane Schneider, PU PH
Organizational Affiliation
Department of Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of gastroenterology, Department of Gerontology
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Combined Effects of Resistance Training and Nutritional Supplements in the Treatment of Sarcopenia
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