Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone

December 26, 2012 updated by: Phil Chilibeck, University of Saskatchewan

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

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • 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).
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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

January 26, 2010

First Submitted That Met QC Criteria

January 26, 2010

First Posted (Estimate)

January 27, 2010

Study Record Updates

Last Update Posted (Estimate)

December 27, 2012

Last Update Submitted That Met QC Criteria

December 26, 2012

Last Verified

December 1, 2012

More Information

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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