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Dietary Supplements and Aging Muscle

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Amy Ellis, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01057082
First received: January 26, 2010
Last updated: March 16, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Sarcopenia
 Dietary Supplement: Juven

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dietary Supplements and Aging Muscle: Specific Amino Acids to Combat Sarcopenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Fat-free mass as determined by a four-compartment model of body composition [ Time Frame: Baseline, 3-months, 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Appendicular lean mass as determined by dual energy X-ray absorptiometry [ Time Frame: Baseline, 3-months, 6-months ] [ Designated as safety issue: No ]
  • Muscle volume as determined by magnetic resonance imaging [ Time Frame: Baseline and 6-months ] [ Designated as safety issue: No ]
  • Physical function as determined by questionnaire and a battery of physical performance tests [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: February 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Juven
Participants in the treatment arm will receive the dietary supplement Juven.
 Dietary Supplement: Juven
Participants in the treatment arm will be asked to consume 2 packets of Juven drink mix each day for a period of six months.
Placebo Comparator: Placebo Dietary Supplement: Juven
Participants in the placebo arm will be asked to consume two packets of an orange-flavored drink mix each day for a period of six months.

  Eligibility

Ages Eligible for Study:   65 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057082

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Amy C Ellis, MPH University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Amy Ellis, Registered Dietitian; Graduate Fellow, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01057082     History of Changes
Other Study ID Numbers: F100107001, F31AT005384-01
Study First Received: January 26, 2010
Last Updated: March 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Sarcopenia
Aging
Muscle
Dietary Supplement
 HMB
Arginine
Glutamine

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
 Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013