SarcopeniaOTRNCT00473902
Older Adult Training Study With Creatine and CLA
A study testing Training and Creatine Monohydrate, Conjugated Linoleic Acid in people with Sarcopenia, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
We examined whether creatine monohydrate (CrM) and conjugated linoleic acid (CLA) could enhance strength gains and improve body composition (i.e., increase fat-free mass (FFM); decrease body fat) following resistance exercise training in older adults (> 65 y). Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Training and Creatine Monohydrate, Conjugated Linoleic Acid
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2003to Sep 2004
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy,
- Ambulatory,
- Recreationally active,
- Community dwelling
Who cannot join
- Evidence of coronary heart disease;
- Congestive heart disease;
- Uncontrolled hypertension;
- Chronic obstructive pulmonary disease;
- Diabetes mellitus;
- Renal failure;
- Major orthopedic disability; and
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Creatine Monohydrate and Conjugated Linoleic Acid Improve Strength and Body Composition Following Resistance Exercise in Older Adults
We examined whether creatine monohydrate (CrM) and conjugated linoleic acid (CLA) could enhance strength gains and improve body composition (i.e., increase fat-free mass (FFM); decrease body fat) following resistance exercise training in older adults (> 65 y). Our study hypothesized that administering CrM and CLA would yield greater strength and body composition benefits than the placebo group over the six months of resistance exercise
Read the detailed description
Men (N=19) and women (N=20) completed six months of resistance exercise training with Creatine Monohydrate (5g/d) + Conjugated Linoleic Acid (6g/d) or placebo with randomized, double-blind, allocation.Outcomes included; strength and muscular endurance, functional tasks, body composition (DEXA scan), blood tests (lipids, liver function, CK, glucose, systemic inflammation markers (IL-6, C-reactive protein)), urinary markers of compliance (creatine/creatinine), oxidative stress (8-OH-2dG, 8-isoP) and bone resorption (Ν-telopeptides).
- Conditions
- Sarcopenia
- Being tested
- Training, Creatine Monohydrate, Conjugated Linoleic Acid
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Creatine Monohydrate, Conjugated Linoleic AcidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
a. Muscle and bone mass b. Knee extension strength e. Creatine content f. Muscle oxidative capacity g. Aerobic power (oxygen consumption)
Measured: six months
Secondary outcomes (1)
a. Functional capacity b. Strength with weight machines
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startAug 2003
- Study completionSep 2004
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Investigators
- Mark A Tarnopolsky, M.D., Ph.D., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473902
- Sponsor's protocol ID
- Older Adult Training Study
- Acronym
- OTR
- Status last verified
- May 2007
- First submitted
- 15 May 2007
- Last updated
- 16 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Tarnopolsky M, Zimmer A, Paikin J, Safdar A, Aboud A, Pearce E, Roy B, Doherty T. Creatine monohydrate and conjugated linoleic acid improve strength and body composition following resistance exercise in older adults. PLoS One. 2007 Oct 3;2(10):e991. doi: 10.1371/journal.pone.0000991.
PubMed 17912368
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine Monohydrate and Conjugated Linoleic Acid Improve Strength and Body Composition Following Resistance Exercise in Older Adults
- ClinicalTrials.gov ID
- NCT00473902
- Acronym / sponsor ID
- OTR / Older Adult Training Study
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Aug 2003
- Study completion
- Sep 2004 (actual)
- First posted
- 16 May 2007 (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.
We examined whether creatine monohydrate (CrM) and conjugated linoleic acid (CLA) could enhance strength gains and improve body composition (i.e., increase fat-free mass (FFM); decrease body fat) following resistance exercise training in older adults (> 65 y). Our study hypothesized that administering CrM and CLA would yield greater strength and body composition benefits than the placebo group over the six months of resistance exercise
Detailed description
Men (N=19) and women (N=20) completed six months of resistance exercise training with Creatine Monohydrate (5g/d) + Conjugated Linoleic Acid (6g/d) or placebo with randomized, double-blind, allocation.Outcomes included; strength and muscular endurance, functional tasks, body composition (DEXA scan), blood tests (lipids, liver function, CK, glucose, systemic inflammation markers (IL-6, C-reactive protein)), urinary markers of compliance (creatine/creatinine), oxidative stress (8-OH-2dG, 8-isoP) and bone resorption (Ν-telopeptides).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Healthy,
- Ambulatory,
- Recreationally active,
- Community dwelling
Key exclusion criteria (8 listed)
- Evidence of coronary heart disease;
- Congestive heart disease;
- Uncontrolled hypertension;
- Chronic obstructive pulmonary disease;
- Diabetes mellitus;
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 |
|---|---|---|
| Training | Behavioural | – |
| Creatine Monohydrate, Conjugated Linoleic Acid | Drug | – |
Primary outcome
a. Muscle and bone mass b. Knee extension strength e. Creatine content f. Muscle oxidative capacity g. Aerobic power (oxygen consumption)
Time frame: six months
1 secondary outcome
a. Functional capacity b. Strength with weight machines
Time frame: six months
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 16 May 2007.
- Derived from this study: PubMed 17912368Tarnopolsky M, Zimmer A, Paikin J, Safdar A, Aboud A, Pearce E, Roy B, Doherty T. Creatine monohydrate and conjugated linoleic acid improve strength and body composition following resistance exercise in older adults. PLoS One. 2007 Oct 3;2(10):e991. doi: 10.1371/journal.pone.0000991.
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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.
Mark A Tarnopolsky, M.D., Ph.D. principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training and Creatine Monohydrate, Conjugated Linoleic Acid in people with Sarcopenia, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 4 inclusion and 8 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 16 May 2007. 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 Canada. 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.
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?
a. Muscle and bone mass b. Knee extension strength e. Creatine content f. Muscle oxidative capacity g. Aerobic power (oxygen consumption) (time frame: six months). 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 NCT00473902, 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 16 May 2007.