Muscle Loss in ElderlyNCT01004588
The Effects of Resistance Training and Protein Supplementation in Healthy Elderly Men and Women.
A study testing Protein drink in people with Muscle Loss in Elderly, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The main objective of this study is to examine the effects of resistance type exercise training combined with nutritional support on body composition and muscle characteristics in healthy elderly men and women. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Loss in Elderly
- What is being tested?
- Protein drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2009to Nov 2012
- Phase
- Interventional
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- over 65 years
- healthy men and women
Who cannot join
- cardiovascular disease
- COPD
- Parkinson
- rheumatoid arthritis
- musculoskeletal/orthopaedic disorders
- cognitive impairment
- subjects with metal implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Resistance Type Exercise Training and Protein Supplementation on Skeletal Muscle Mass, Strength, and Muscle Characteristics in Healthy Elderly Men and Women
The main objective of this study is to examine the effects of resistance type exercise training combined with nutritional support on body composition and muscle characteristics in healthy elderly men and women. For a comprehensive insight into the potential underlying mechanisms of the intervention effects on whole body-, muscle- and myocellular level, a broad range of tests will be performed before, during, and after the intervention period.
- Conditions
- Muscle Loss in Elderly
- Being tested
- Protein drink, placebo drink
- Keywords
- elderly, sarcopenia, protein drink, resistance training
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein drinkDietary supplement
total of 15 g protein/d in a protein drink consumed every morning after breakfast during 24 weeks
placebo drinkDietary supplement
subjects consume a placebo drink every morning after breakfast over a period of 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Protein drink | Experimental | protein drink Receives: Dietary Supplement: Protein drink |
| Placebo drink | Placebo comparator | Placebo drink Receives: Dietary Supplement: placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle mass measured by DXA-scan and CT-scan
Measured: 0, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Loss in ElderlyStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Responsible party
- Sponsor
- Investigators
- Marika Leenders, MSc, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004588
- Sponsor's protocol ID
- MEC 09-3-056
- Status last verified
- Apr 2015
- First submitted
- 26 Oct 2009
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Resistance Type Exercise Training and Protein Supplementation on Skeletal Muscle Mass, Strength, and Muscle Characteristics in Healthy Elderly Men and Women
- ClinicalTrials.gov ID
- NCT01004588
- Acronym / sponsor ID
- MEC 09-3-056
- Conditions
- Muscle Loss in Elderly
- Keywords
- elderly, sarcopenia, protein drink, resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Nov 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Oct 2009 (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.
The main objective of this study is to examine the effects of resistance type exercise training combined with nutritional support on body composition and muscle characteristics in healthy elderly men and women. For a comprehensive insight into the potential underlying mechanisms of the intervention effects on whole body-, muscle- and myocellular level, a broad range of tests will be performed before, during, and after the intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein drink | Experimental | Dietary Supplement: Protein drinkprotein drink |
| Placebo drink | Placebo comparator | Dietary Supplement: placebo drinkPlacebo drink |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- over 65 years
- healthy men and women
Key exclusion criteria (7 listed)
- cardiovascular disease
- COPD
- Parkinson
- rheumatoid arthritis
- musculoskeletal/orthopaedic disorders
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 |
|---|---|---|
| Protein drinktotal of 15 g protein/d in a protein drink consumed every morning after breakfast during 24 weeks | Dietary supplement | Protein drink |
| placebo drinksubjects consume a placebo drink every morning after breakfast over a period of 24 weeks. | Dietary supplement | Placebo drink |
Primary outcome
Change in muscle mass measured by DXA-scan and CT-scan
Time frame: 0, 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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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.
Marika Leenders, MSc principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein drink in people with Muscle Loss in Elderly, run by Maastricht University Medical Center at 1 site in Netherlands.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 10 Apr 2015. 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in muscle mass measured by DXA-scan and CT-scan (time frame: 0, 12 and 24 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 10 Apr 2015.