- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01057680
Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone
Potential of Resistance-Exercise and Creatine Supplementation on Aging Musculoskeletal Health
As we age, we experience a reduction in muscle and bone which inevitably decreases strength and the ability to perform tasks of daily living such as gardening, carrying groceries, and climbing stairs. Health costs associated with aging muscle and bone loss are in the billions of dollars. With the projected increase in life expectancy, the incidence of muscle and bone loss will rise and further drain the healthcare system, with greater need for hospitalization, treatment, and rehabilitation. Without effective strategies to counteract aging muscle and bone loss, we may face a healthcare crisis in the future. Creatine, a compound found in red meat and seafood, increases creatine phosphate stores in muscle, providing increased energy during high-intensity exercise. Short-term (i.e. 3-4 months) resistance-exercise and supplementation with creatine, have been shown to have a favorable effect on properties of aging muscle and bone. However, the longer-term (i.e. 1 year) effects of these interventions are unknown. Therefore, the purpose of this innovative research is to determine the longer-term effects of resistance-exercise and creatine supplementation (0.1g•kg-1) in older adults. The primary dependent variables to be assessed will include muscle hypertrophy, bone mineral and bone geometry, strength, and urinary and blood indicators of liver and kidney function. This innovative, multidisciplinary research will help contribute to the successful pursuit of prolonged independent living by improving aging musculoskeletal health for older Saskatchewan adults. Saskatchewan provides a relevant setting for this research, given the higher percentage of older adults (15%), compared to the national average (12%).
We hypothesize that creatine supplementation will increase muscle mass, strength, and bone mineral density more than placebo.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4S 0A2
- Faculty of Kinesiology and Health Sciences
-
Saskatoon, Saskatchewan, Canada, S7N 5B2
- College of Kinesiology, University of Saskatchewan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- greater than or equal to 50 years of age
- males or postmenopausal females
- not currently participating in resistance training
Exclusion Criteria:
- pre-existing kidney abnormalities
- previous fragility fractures
- history of taking medications that affect bone mineral density in the past year including bisphosphonates, parathyroid hormone, calcitonin, hormone replacement therapy, or corticosteroids (i.e. within the past year)
- suffer from severe osteoarthritis
- have taken creatine supplementation within the past 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: creatine
This arm will involve creatine supplementation 0.1 g per kg body mass per day while participating in a resistance training program (1 hour per day, 3 days per week).
|
Powder, 0.1 g per day, 12 months
Other Names:
|
|
Placebo Comparator: Sugar
This arm will involve placebo (maltodextrin) given every day while the participant does a resistance training program (1 hour per day, 3 days per week).
|
powder, 0.1 g/day, 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Lumbar spine bone mineral density
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proximal femur bone mineral density
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
|
Whole body bone mineral density
Time Frame: baseline and 12 months
|
baseline and 12 months
|
|
lean tissue mass
Time Frame: baseline and 12 months
|
baseline and 12 months
|
|
Muscular strength
Time Frame: baseline and 12 months
|
baseline and 12 months
|
|
Muscle thickness
Time Frame: baseline and 12 months
|
baseline and 12 months
|
|
Bone speed of sound
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
|
bone geometry
Time Frame: baseline and 12 months
|
baseline and 12 months
|
|
Complete blood count
Time Frame: baseline, 4 months, 8 months, 12 months
|
baseline, 4 months, 8 months, 12 months
|
|
Liver enzymes
Time Frame: baseline, 4 months, 8 months, 12 months
|
baseline, 4 months, 8 months, 12 months
|
|
kidney function (creatinine clearance)
Time Frame: baseline, 4 months, 8 months, 12 months
|
baseline, 4 months, 8 months, 12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-169
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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