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OpenTrials
Completed

NCT Number: NCT01057082

Dietary Supplements and Aging Muscle

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Juven

Dietary Supplement

Participants in the treatment arm will be asked to consume 2 packets of Juven drink mix each day for a period of six months.

Primary outcomes

  1. Fat-free mass as determined by a four-compartment model of body composition

    Time frame: Baseline, 3-months, 6-months

Secondary outcomes

  1. Appendicular lean mass as determined by dual energy X-ray absorptiometry

    Time frame: Baseline, 3-months, 6-months

  2. Muscle volume as determined by magnetic resonance imaging

    Time frame: Baseline and 6-months

  3. Physical function as determined by questionnaire and a battery of physical performance tests

    Time frame: Baseline and 6 months

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Dietary Supplements and Aging Muscle: Specific Amino Acids to Combat Sarcopenia

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 27, 2010
Registry last updated
Mar 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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