NCT01057082CompletedNot Applicable
Dietary Supplements and Aging Muscle: Specific Amino Acids to Combat Sarcopenia
University of Alabama at Birmingham1 site in 1 country36 target enrollmentStarted: February 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Fat-free mass as determined by a four-compartment model of body composition
Study Overview
Brief Summary
The purpose of this study is to determine whether older adults (ages 65-89) who consume the dietary supplement Juven (Abbott Laboratories) versus placebo for 6 months will demonstrate increases in fat-free mass, muscle volume,and physical function.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to 89 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Ages 65-89
- •Ambulatory
Exclusion Criteria
- •Cognitive impairment
- •History of renal or hepatic disease
- •History of hypotension
- •History of peripheral artery disease
- •Uncontrolled hypertension
- •Uncontrolled diabetes
- •Self-reported claustrophobia
- •Current smoker
- •Steroid or androgen use with the previous 3 months
- •Individuals with pacemakers and defibrillators
Arms & Interventions
Juven
Experimental
Participants in the treatment arm will receive the dietary supplement Juven.
Intervention: Juven (Dietary Supplement)
Placebo
Placebo Comparator
Intervention: Juven (Dietary Supplement)
Outcomes
Primary Outcomes
Fat-free mass as determined by a four-compartment model of body composition
Time Frame: Baseline, 3-months, 6-months
Secondary Outcomes
- Appendicular lean mass as determined by dual energy X-ray absorptiometry(Baseline, 3-months, 6-months)
- Muscle volume as determined by magnetic resonance imaging(Baseline and 6-months)
- Physical function as determined by questionnaire and a battery of physical performance tests(Baseline and 6 months)
Investigators
Amy Ellis
Registered Dietitian; Graduate Fellow
University of Alabama at Birmingham
Study Sites (1)
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