SarcopeniaPhase 1/2NCT00807508
Leucine Supplementation in Elderly Men
A Phase 1/2 study testing leucine 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 leucine supplementation can augment muscle mass and strength and improve body composition 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?
- leucine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2007to Dec 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 history of resistance training in past 5 years
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, 6200 MD
About this study
Official title: The Influence of Leucine Supplementation on Body Composition and Muscle Characteristics in Healthy Elderly
In the present study the investigators aim to determine whether leucine supplementation can augment muscle mass and strength and improve body composition in healthy elderly men
- Conditions
- Sarcopenia, Atrophy, Aging
- Being tested
- placebo, leucine
- Medical subject headings
- Sarcopenia, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDietary supplement
wheat meal capsules with each main meal
leucineDietary supplement
daily leucine capsules with each main meal
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | daily leucine supplementation Receives: Dietary Supplement: leucine |
| 2 | Placebo comparator | daily placebo supplementation Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle mass and body composition
Measured: before and after 12 wk intervention
Secondary outcomes (1)
muscle strength
Measured: before and after 12 wk intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2007
- Study completionDec 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
- Double blind
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Luc JC van Loon, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807508
- Sponsor's protocol ID
- MEC 06-3-062A
- Status last verified
- Dec 2008
- First submitted
- 11 Dec 2008
- Last updated
- 12 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Verhoeven S, Vanschoonbeek K, Verdijk LB, Koopman R, Wodzig WK, Dendale P, van Loon LJ. Long-term leucine supplementation does not increase muscle mass or strength in healthy elderly men. Am J Clin Nutr. 2009 May;89(5):1468-75. doi: 10.3945/ajcn.2008.26668. Epub 2009 Mar 25.
PubMed 19321567
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Leucine Supplementation on Body Composition and Muscle Characteristics in Healthy Elderly
- ClinicalTrials.gov ID
- NCT00807508
- Acronym / sponsor ID
- MEC 06-3-062A
- Conditions
- Sarcopenia, Atrophy, Aging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Dec 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 leucine supplementation can augment muscle mass and strength and improve body composition in healthy elderly men
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: leucinedaily leucine supplementation |
| 2 | Placebo comparator | Dietary Supplement: placebodaily placebo supplementation |
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 (1 listed)
- Diabetes cardiovascular disease orthopedic limitations 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 |
|---|---|---|
| placebowheat meal capsules with each main meal | Dietary supplement | 2 |
| leucinedaily leucine capsules with each main meal | Dietary supplement | 1 |
Primary outcome
muscle mass and body composition
Time frame: before and after 12 wk intervention
1 secondary outcome
muscle strength
Time frame: before and after 12 wk 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 12 Dec 2008.
- Derived from this study: PubMed 19321567Verhoeven S, Vanschoonbeek K, Verdijk LB, Koopman R, Wodzig WK, Dendale P, van Loon LJ. Long-term leucine supplementation does not increase muscle mass or strength in healthy elderly men. Am J Clin Nutr. 2009 May;89(5):1468-75. doi: 10.3945/ajcn.2008.26668. Epub 2009 Mar 25.
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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 Medical Center
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 leucine 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 1 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 12 Dec 2008. 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 and body composition (time frame: before and after 12 wk 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 NCT00807508, 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 12 Dec 2008; AzTrials last refreshed its copy on 26 Oct 2026.