Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone
Primary Purpose
Osteoporosis, Sarcopenia
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
creatine monohydrate
sugar placebo
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Bone, Muscle, Strength, Kidney, Liver, Creatine
Eligibility Criteria
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
Sites / Locations
- Faculty of Kinesiology and Health Sciences
- College of Kinesiology, University of Saskatchewan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
creatine
Sugar
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Lumbar spine bone mineral density
Secondary Outcome Measures
Proximal femur bone mineral density
Whole body bone mineral density
lean tissue mass
Muscular strength
Muscle thickness
Bone speed of sound
bone geometry
Complete blood count
Liver enzymes
kidney function (creatinine clearance)
Full Information
NCT ID
NCT01057680
First Posted
January 26, 2010
Last Updated
December 26, 2012
Sponsor
University of Saskatchewan
1. Study Identification
Unique Protocol Identification Number
NCT01057680
Brief Title
Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone
Official Title
Potential of Resistance-Exercise and Creatine Supplementation on Aging Musculoskeletal Health
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Sarcopenia
Keywords
Bone, Muscle, Strength, Kidney, Liver, Creatine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
creatine
Arm Type
Experimental
Arm Description
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).
Arm Title
Sugar
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
creatine monohydrate
Other Intervention Name(s)
Rivalus
Intervention Description
Powder, 0.1 g per day, 12 months
Intervention Type
Dietary Supplement
Intervention Name(s)
sugar placebo
Intervention Description
powder, 0.1 g/day, 12 months
Primary Outcome Measure Information:
Title
Lumbar spine bone mineral density
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Proximal femur bone mineral density
Time Frame
Baseline and 12 months
Title
Whole body bone mineral density
Time Frame
baseline and 12 months
Title
lean tissue mass
Time Frame
baseline and 12 months
Title
Muscular strength
Time Frame
baseline and 12 months
Title
Muscle thickness
Time Frame
baseline and 12 months
Title
Bone speed of sound
Time Frame
Baseline and 12 months
Title
bone geometry
Time Frame
baseline and 12 months
Title
Complete blood count
Time Frame
baseline, 4 months, 8 months, 12 months
Title
Liver enzymes
Time Frame
baseline, 4 months, 8 months, 12 months
Title
kidney function (creatinine clearance)
Time Frame
baseline, 4 months, 8 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Chilibeck, Ph.D.
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Darren Candow, Ph.D.
Organizational Affiliation
University of Regina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Kinesiology and Health Sciences
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A2
Country
Canada
Facility Name
College of Kinesiology, University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 5B2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
34107512
Citation
Candow DG, Chilibeck PD, Gordon JJ, Kontulainen S. Efficacy of Creatine Supplementation and Resistance Training on Area and Density of Bone and Muscle in Older Adults. Med Sci Sports Exerc. 2021 Nov 1;53(11):2388-2395. doi: 10.1249/MSS.0000000000002722.
Results Reference
derived
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Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone
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