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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00473902
Other study ID # Older Adult Training Study
Secondary ID
Status Completed
Phase N/A
First received May 15, 2007
Last updated May 15, 2007
Start date August 2003
Est. completion date September 2004

Study information

Verified date May 2007
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical 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). 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


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).


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date September 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years to 85 Years
Eligibility Inclusion Criteria:

- Healthy,

- Ambulatory,

- Recreationally active,

- Community dwelling

Exclusion Criteria:

- Evidence of coronary heart disease;

- Congestive heart disease;

- Uncontrolled hypertension;

- Chronic obstructive pulmonary disease;

- Diabetes mellitus;

- Renal failure;

- Major orthopedic disability; and

- Smoking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Training

Drug:
Creatine Monohydrate, Conjugated Linoleic Acid


Locations

Country Name City State
Canada McMaster University Medical Center Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary a. Muscle and bone mass b. Knee extension strength e. Creatine content f. Muscle oxidative capacity g. Aerobic power (oxygen consumption) six months
Secondary a. Functional capacity b. Strength with weight machines six months
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