Dietary Supplements and Aging Muscle
2 other identifiers
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 19, 2012
March 1, 2012
1.8 years
January 26, 2010
March 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fat-free mass as determined by a four-compartment model of body composition
Baseline, 3-months, 6-months
Secondary Outcomes (3)
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
Study Arms (2)
Juven
EXPERIMENTALParticipants in the treatment arm will receive the dietary supplement Juven.
Placebo
PLACEBO COMPARATORInterventions
Participants in the treatment arm will be asked to consume 2 packets of Juven drink mix each day for a period of six months.
Eligibility Criteria
You may qualify if:
- Ages 65-89
- Ambulatory
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Related Publications (1)
Ellis AC, Hunter GR, Goss AM, Gower BA. Oral Supplementation with Beta-Hydroxy-Beta-Methylbutyrate, Arginine, and Glutamine Improves Lean Body Mass in Healthy Older Adults. J Diet Suppl. 2019;16(3):281-293. doi: 10.1080/19390211.2018.1454568. Epub 2018 Apr 19.
PMID: 29672184DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy C Ellis, MPH
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Registered Dietitian; Graduate Fellow
Study Record Dates
First Submitted
January 26, 2010
First Posted
January 27, 2010
Study Start
February 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 19, 2012
Record last verified: 2012-03