Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone

Osteoporosis Clinical Trial

Official title:

Potential of Resistance-Exercise and Creatine Supplementation on Aging Musculoskeletal Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057680
• Other study ID #: 09-169
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2010
• Last updated: December 26, 2012
• Start date: January 2010
• Est. completion date: February 2012

Study information

• Verified date: December 2012
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis
• Sarcopenia

Intervention

Dietary Supplement:
• creatine monohydrate
Powder, 0.1 g per day, 12 months
• sugar placebo
powder, 0.1 g/day, 12 months

Locations

Country	Name	City	State
Canada	Faculty of Kinesiology and Health Sciences	Regina	Saskatchewan
Canada	College of Kinesiology, University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar spine bone mineral density		Baseline and 12 months	No
Secondary	Proximal femur bone mineral density		Baseline and 12 months	No
Secondary	Whole body bone mineral density		baseline and 12 months	No
Secondary	lean tissue mass		baseline and 12 months	No
Secondary	Muscular strength		baseline and 12 months	No
Secondary	Muscle thickness		baseline and 12 months	No
Secondary	Bone speed of sound		Baseline and 12 months	No
Secondary	bone geometry		baseline and 12 months	No
Secondary	Complete blood count		baseline, 4 months, 8 months, 12 months	Yes
Secondary	Liver enzymes		baseline, 4 months, 8 months, 12 months	Yes
Secondary	kidney function (creatinine clearance)		baseline, 4 months, 8 months, 12 months	Yes