SarcopeniaPhase 1/2NCT00744094
Resistance Training in Elderly
A Phase 1/2 study testing protein drink and Resistance training in people with Sarcopenia and Atrophy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In the present study the investigators aim to determine whether protein supplementation can augment the response to a 12 week resistance training program in healthy elderly men. Read more about this study
- Who is it for?
- Ages 65 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Atrophy, Aging
- What is being tested?
- protein drink and Resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2007to Jul 2008
- Phase
- Phase 1/2
- 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 85 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Living independently
Who cannot join
- Diabetes
- Cardiovascular disease
- Orthopedic limitations
- Any disorder known to compromise ability for resistance training
- History of resistance training in past 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Resistance Training on Body Composition and Muscle Characteristics in Healthy Elderly
In the present study the investigators aim to determine whether protein supplementation can augment the response to a 12 week resistance training program in healthy elderly men.
- Conditions
- Sarcopenia, Atrophy, Aging
- Being tested
- protein drink, Resistance training
- Keywords
- resistance training, protein supplementation, hypertrophy
- Medical subject headings
- Sarcopenia, Atrophy, Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein drinkDietary supplement
250 ml protein hydrolysate solution
Resistance trainingBehavioural
12 weeks resistance training, 3 days per week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | placebo drink Receives: Behavioral: Resistance training |
| 2 | Experimental | protein drink Receives: Dietary Supplement: protein drink; Behavioral: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass measured at limb and cellular level
Measured: before and after 12 weeks of intervention
Secondary outcomes (2)
Muscle strength
Measured: before and after 12 weeks of intervention
Body composition
Measured: before and after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startJan 2007
- Primary completionSep 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Anna Foundation, DSM Food Specialties
- Investigators
- Luc JC van Loon, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744094
- Sponsor's protocol ID
- MEC 06-3-062B
- Status last verified
- Aug 2008
- First submitted
- 28 Aug 2008
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Verdijk LB, Jonkers RA, Gleeson BG, Beelen M, Meijer K, Savelberg HH, Wodzig WK, Dendale P, van Loon LJ. Protein supplementation before and after exercise does not further augment skeletal muscle hypertrophy after resistance training in elderly men. Am J Clin Nutr. 2009 Feb;89(2):608-16. doi: 10.3945/ajcn.2008.26626. Epub 2008 Dec 23.
PubMed 19106243
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Resistance Training on Body Composition and Muscle Characteristics in Healthy Elderly
- ClinicalTrials.gov ID
- NCT00744094
- Acronym / sponsor ID
- MEC 06-3-062B
- Conditions
- Sarcopenia, Atrophy, Aging
- Keywords
- resistance training, protein supplementation, hypertrophy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- The Anna Foundation, DSM Food Specialties
- Study start
- Jan 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 29 Aug 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.
In the present study the investigators aim to determine whether protein supplementation can augment the response to a 12 week resistance training program in healthy elderly men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Behavioral: Resistance trainingplacebo drink |
| 2 | Experimental | Dietary Supplement: protein drink, Behavioral: Resistance trainingprotein drink |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Living independently
Key exclusion criteria (5 listed)
- Diabetes
- Cardiovascular disease
- Orthopedic limitations
- Any disorder known to compromise ability for resistance training
- History of resistance training in past 5 years
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 drink250 ml protein hydrolysate solution | Dietary supplement | 2 |
| Resistance training12 weeks resistance training, 3 days per week | Behavioural | 1, 2 |
Primary outcome
Muscle mass measured at limb and cellular level
Time frame: before and after 12 weeks of intervention
2 secondary outcomes
Muscle strength
Time frame: before and after 12 weeks of intervention
Body composition
Time frame: before and after 12 weeks of intervention
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 23 Sep 2015.
- Derived from this study: PubMed 19106243Verdijk LB, Jonkers RA, Gleeson BG, Beelen M, Meijer K, Savelberg HH, Wodzig WK, Dendale P, van Loon LJ. Protein supplementation before and after exercise does not further augment skeletal muscle hypertrophy after resistance training in elderly men. Am J Clin Nutr. 2009 Feb;89(2):608-16. doi: 10.3945/ajcn.2008.26626. Epub 2008 Dec 23.
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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.
Luc JC van Loon, PhD principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing protein drink and Resistance training in people with Sarcopenia and Atrophy, 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 1 inclusion and 5 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 23 Sep 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Muscle mass measured at limb and cellular level (time frame: before and after 12 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00744094, which also lists 1 linked publication.
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 23 Sep 2015.