Dietary Supplements and Aging Muscle

This study has been completed.
Sponsor:
Collaborator:
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
  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:


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
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 April 16, 2014