Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone

Phase 3

Completed

• Conditions: Osteoporosis; Sarcopenia
• Interventions: Dietary Supplement: creatine monohydrate; Dietary Supplement: sugar placebo

• Registration Number: NCT01057680
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-26
• Study First Posted: 2010-01-27
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-26
• Last Update Posted: 2012-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
creatine	creatine monohydrate	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).
Sugar	sugar placebo	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).

Primary Outcome Measures

Name	Time	Method
Lumbar spine bone mineral density	Baseline and 12 months

Secondary Outcome Measures

Name	Time	Method
Proximal femur bone mineral density	Baseline and 12 months
Whole body bone mineral density	baseline and 12 months
lean tissue mass	baseline and 12 months
Muscular strength	baseline and 12 months
Muscle thickness	baseline and 12 months
Bone speed of sound	Baseline and 12 months
bone geometry	baseline and 12 months
Complete blood count	baseline, 4 months, 8 months, 12 months
Liver enzymes	baseline, 4 months, 8 months, 12 months
kidney function (creatinine clearance)	baseline, 4 months, 8 months, 12 months

Trial Locations

Locations (2)

College of Kinesiology, University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada

Faculty of Kinesiology and Health Sciences; 🇨🇦 Regina, Saskatchewan, Canada