Clinical trial NCT01057680: Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone
Official title: Potential of Resistance-Exercise and Creatine Supplementation on Aging Musculoskeletal Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Sarcopenia
Keywords: Bone
Muscle
Strength
Kidney
Liver
Creatine
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2010-01-27
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Lumbar spine bone mineral density
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Proximal femur bone mineral density
timeFrame: Baseline and 12 months
measure: Whole body bone mineral density
timeFrame: baseline and 12 months
measure: lean tissue mass
timeFrame: baseline and 12 months
measure: Muscular strength
timeFrame: baseline and 12 months
measure: Muscle thickness
timeFrame: baseline and 12 months
measure: Bone speed of sound
timeFrame: Baseline and 12 months
measure: bone geometry
timeFrame: baseline and 12 months
measure: Complete blood count
timeFrame: baseline, 4 months, 8 months, 12 months
measure: Liver enzymes
timeFrame: baseline, 4 months, 8 months, 12 months
measure: kidney function (creatinine clearance)
timeFrame: baseline, 4 months, 8 months, 12 months
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Faculty of Kinesiology and Health Sciences
state: Saskatchewan
city: Saskatoon
country: Canada
facility: College of Kinesiology, University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Philip Chilibeck, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Regina
name: Darren Candow, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Candow DG, Chilibeck PD, Gordon JJ, Kontulainen S. Efficacy of Creatine Supplementation and Resistance Training on Area and Density of Bone and Muscle in Older Adults. Med Sci Sports Exerc. 2021 Nov 1;53(11):2388-2395. doi: 10.1249/MSS.0000000000002722.