Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01057680
First received: January 26, 2010
Last updated: December 26, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Osteoporosis
Sarcopenia
Dietary Supplement: creatine monohydrate
Dietary Supplement: sugar placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Potential of Resistance-Exercise and Creatine Supplementation on Aging Musculoskeletal Health

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Lumbar spine bone mineral density [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proximal femur bone mineral density [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Whole body bone mineral density [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • lean tissue mass [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • Muscular strength [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • Muscle thickness [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • Bone speed of sound [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • bone geometry [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • Complete blood count [ Time Frame: baseline, 4 months, 8 months, 12 months ] [ Designated as safety issue: Yes ]
  • Liver enzymes [ Time Frame: baseline, 4 months, 8 months, 12 months ] [ Designated as safety issue: Yes ]
  • kidney function (creatinine clearance) [ Time Frame: baseline, 4 months, 8 months, 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: January 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057680

Locations
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
Investigators
Principal Investigator: Philip Chilibeck, Ph.D. University of Saskatchewan
Principal Investigator: Darren Candow, Ph.D. University of Regina
  More Information

No publications provided

Responsible Party: Phil Chilibeck, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01057680     History of Changes
Other Study ID Numbers: 09-169
Study First Received: January 26, 2010
Last Updated: December 26, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Saskatchewan:
Bone
Muscle
Strength
Kidney
Liver
Creatine

Additional relevant MeSH terms:
Osteoporosis
Sarcopenia
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014