SarcopeniaPhase 3NCT00748696
Combined Effects of Resistance Training and Nutritional Supplements in the Treatment of Sarcopenia
A Phase 3 study testing Fortimel Extra®, resistance training and combined treatment in people with Sarcopenia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Fortimel Extra®, resistance training and combined treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2006to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Department of gastroenterology, Department of Gerontology
Nice, 06000
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Fortimel Extra®, resistance training, combined treatment
- Keywords
- sarcopenia, elderly, resistance training, oral nutritional supplement
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortimel Extra®Dietary supplement
260kcal and 20g protein per day
resistance trainingOther
3 sessions of resistance training per week
combined treatmentOther
260kcal and 20g protein per day 3 sessions of resistance training per week
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | No intervention |
| 2 | Experimental | patient receiving oral nutrition supplement Receives: Dietary Supplement: Fortimel Extra® |
| 3 | Experimental | resistance training Receives: Other: resistance training |
| 4 | Experimental | patients receiving resistance training and oral nutritional supplement Receives: Other: combined treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle mass (DXA)
Measured: D0 and after 12 weeks
Secondary outcomes (1)
muscle function (dynamometers), hormonal (testosterone, GH, IGF-1, cortisol) and inflammatory (IL-6, TNF-alpha) profiles, food intake, ± muscle biopsy.
Measured: D0 and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephane Schneider, PU PH, Principal investigator, Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748696
- Sponsor's protocol ID
- 06-API-04
- Status last verified
- Jun 2009
- First submitted
- 4 Sep 2008
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Resistance Training and Nutritional Supplements in the Treatment of Sarcopenia
- ClinicalTrials.gov ID
- NCT00748696
- Acronym / sponsor ID
- 06-API-04
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, elderly, resistance training, oral nutritional supplement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –No intervention |
| 2 | Experimental | Dietary Supplement: Fortimel Extra®patient receiving oral nutrition supplement |
| 3 | Experimental | Other: resistance trainingresistance training |
| 4 | Experimental | Other: combined treatmentpatients receiving resistance training and oral nutritional supplement |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fortimel Extra®260kcal and 20g protein per day | Dietary supplement | 2 |
| resistance training3 sessions of resistance training per week | Other | 3 |
| combined treatment260kcal and 20g protein per day 3 sessions of resistance training per week | Other | 4 |
Primary outcome
muscle mass (DXA)
Time frame: D0 and after 12 weeks
1 secondary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephane Schneider, PU PH principal investigator
Department of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fortimel Extra®, resistance training and combined treatment in people with Sarcopenia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle mass (DXA) (time frame: D0 and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.