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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.
 
ClinicalTrials.gov Identifier: NCT01057680
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : December 27, 2012
Sponsor:
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan

Tracking Information
First Submitted Date  ICMJE January 26, 2010
First Posted Date  ICMJE January 27, 2010
Last Update Posted Date December 27, 2012
Study Start Date  ICMJE January 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2010)
Lumbar spine bone mineral density [ Time Frame: Baseline and 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01057680 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2010)
  • Proximal femur bone mineral density [ Time Frame: Baseline and 12 months ]
  • Whole body bone mineral density [ Time Frame: baseline and 12 months ]
  • lean tissue mass [ Time Frame: baseline and 12 months ]
  • Muscular strength [ Time Frame: baseline and 12 months ]
  • Muscle thickness [ Time Frame: baseline and 12 months ]
  • Bone speed of sound [ Time Frame: Baseline and 12 months ]
  • bone geometry [ Time Frame: baseline and 12 months ]
  • Complete blood count [ Time Frame: baseline, 4 months, 8 months, 12 months ]
  • Liver enzymes [ Time Frame: baseline, 4 months, 8 months, 12 months ]
  • kidney function (creatinine clearance) [ Time Frame: baseline, 4 months, 8 months, 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone
Official Title  ICMJE Potential of Resistance-Exercise and Creatine Supplementation on Aging Musculoskeletal Health
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Osteoporosis
  • Sarcopenia
Intervention  ICMJE
  • Dietary Supplement: creatine monohydrate
    Powder, 0.1 g per day, 12 months
    Other Name: Rivalus
  • Dietary Supplement: sugar placebo
    powder, 0.1 g/day, 12 months
Study Arms  ICMJE
  • 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).
    Intervention: Dietary Supplement: creatine monohydrate
  • 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).
    Intervention: Dietary Supplement: sugar placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 26, 2012)
90
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2010)
100
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01057680
Other Study ID Numbers  ICMJE 09-169
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Phil Chilibeck, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Chilibeck, Ph.D. University of Saskatchewan
Principal Investigator: Darren Candow, Ph.D. University of Regina
PRS Account University of Saskatchewan
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP