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Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01057680
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : December 27, 2012
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Sarcopenia Dietary Supplement: creatine monohydrate Dietary Supplement: sugar placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Potential of Resistance-Exercise and Creatine Supplementation on Aging Musculoskeletal Health
Study Start Date : January 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

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).
Dietary Supplement: creatine monohydrate
Powder, 0.1 g per day, 12 months
Other Name: Rivalus

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).
Dietary Supplement: sugar placebo
powder, 0.1 g/day, 12 months

Primary Outcome Measures :
  1. Lumbar spine bone mineral density [ Time Frame: Baseline and 12 months ]

Secondary Outcome Measures :
  1. Proximal femur bone mineral density [ Time Frame: Baseline and 12 months ]
  2. Whole body bone mineral density [ Time Frame: baseline and 12 months ]
  3. lean tissue mass [ Time Frame: baseline and 12 months ]
  4. Muscular strength [ Time Frame: baseline and 12 months ]
  5. Muscle thickness [ Time Frame: baseline and 12 months ]
  6. Bone speed of sound [ Time Frame: Baseline and 12 months ]
  7. bone geometry [ Time Frame: baseline and 12 months ]
  8. Complete blood count [ Time Frame: baseline, 4 months, 8 months, 12 months ]
  9. Liver enzymes [ Time Frame: baseline, 4 months, 8 months, 12 months ]
  10. kidney function (creatinine clearance) [ Time Frame: baseline, 4 months, 8 months, 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01057680

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Canada, Saskatchewan
Faculty of Kinesiology and Health Sciences
Regina, Saskatchewan, Canada, S4S 0A2
College of Kinesiology, University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 5B2
Sponsors and Collaborators
University of Saskatchewan
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Principal Investigator: Philip Chilibeck, Ph.D. University of Saskatchewan
Principal Investigator: Darren Candow, Ph.D. University of Regina
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Responsible Party: Phil Chilibeck, Professor, University of Saskatchewan Identifier: NCT01057680    
Other Study ID Numbers: 09-169
First Posted: January 27, 2010    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: December 2012
Keywords provided by Phil Chilibeck, University of Saskatchewan:
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical