Older Adult Training Study With Creatine and CLA (OTR)
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Training
Creatine Monohydrate, Conjugated Linoleic Acid
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia
Eligibility Criteria
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
Sites / Locations
- McMaster University Medical Center
Outcomes
Primary Outcome Measures
a. Muscle and bone mass b. Knee extension strength e. Creatine content f. Muscle oxidative capacity g. Aerobic power (oxygen consumption)
Secondary Outcome Measures
a. Functional capacity b. Strength with weight machines
Full Information
NCT ID
NCT00473902
First Posted
May 15, 2007
Last Updated
May 15, 2007
Sponsor
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00473902
Brief Title
Older Adult Training Study With Creatine and CLA
Acronym
OTR
Official Title
Creatine Monohydrate and Conjugated Linoleic Acid Improve Strength and Body Composition Following Resistance Exercise in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hamilton Health Sciences Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Training
Intervention Type
Drug
Intervention Name(s)
Creatine Monohydrate, Conjugated Linoleic Acid
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
a. Functional capacity b. Strength with weight machines
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Tarnopolsky, M.D., Ph.D.
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University Medical Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
17912368
Citation
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.
Results Reference
derived
Learn more about this trial
Older Adult Training Study With Creatine and CLA
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