Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone

NCT01057680 | Completed Phase 3 DMC

• 1 other identifier: 09-169
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoporosis; Sarcopenia

Keywords

Bone; Muscle; Strength; Kidney; Liver; Creatine

Outcome Measures

Primary Outcomes (1)

• Lumbar spine bone mineral density

  Baseline and 12 months

Secondary Outcomes (10)

• 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

Study Arms (2)

creatine

EXPERIMENTAL

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

Sugar

PLACEBO COMPARATOR

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

Interventions

creatine monohydrate DIETARY_SUPPLEMENT

Powder, 0.1 g per day, 12 months

Also known as: Rivalus

creatine

sugar placebo DIETARY_SUPPLEMENT

powder, 0.1 g/day, 12 months

Sugar

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• greater than or equal to 50 years of age
• males or postmenopausal females
• not currently participating in resistance training

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (2)

Faculty of Kinesiology and Health Sciences

Regina, Saskatchewan, S4S 0A2, Canada

Location

College of Kinesiology, University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Location

Related Publications (1)

• 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.

  PMID: 34107512 DERIVED

MeSH Terms

Conditions

Osteoporosis; Sarcopenia

Interventions

Creatine

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Philip Chilibeck, Ph.D.

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

• Darren Candow, Ph.D.

  University of Regina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 27, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 27, 2012

Record last verified: 2012-12

Locations

CA (2)