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Dietary Supplements and Aging Muscle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01057082
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : March 19, 2012
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Amy Ellis, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE January 26, 2010
First Posted Date  ICMJE January 27, 2010
Last Update Posted Date March 19, 2012
Study Start Date  ICMJE February 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2010)
Fat-free mass as determined by a four-compartment model of body composition [ Time Frame: Baseline, 3-months, 6-months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01057082 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2010)
  • Appendicular lean mass as determined by dual energy X-ray absorptiometry [ Time Frame: Baseline, 3-months, 6-months ]
  • Muscle volume as determined by magnetic resonance imaging [ Time Frame: Baseline and 6-months ]
  • Physical function as determined by questionnaire and a battery of physical performance tests [ Time Frame: Baseline and 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dietary Supplements and Aging Muscle
Official Title  ICMJE Dietary Supplements and Aging Muscle: Specific Amino Acids to Combat Sarcopenia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Sarcopenia
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Juven
    Participants in the treatment arm will receive the dietary supplement Juven.
    Intervention: Dietary Supplement: Juven
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Juven
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2010)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 89 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01057082
Other Study ID Numbers  ICMJE F100107001
F31AT005384-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amy Ellis, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Amy C Ellis, MPH University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP