Dietary Supplements and Aging Muscle

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057082
• Other study ID #: F100107001
• Secondary ID: F31AT005384-01
• Status: Completed
• Phase: N/A
• First received: January 26, 2010
• Last updated: March 16, 2012
• Start date: February 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 89 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat-free mass as determined by a four-compartment model of body composition		Baseline, 3-months, 6-months	No
Secondary	Appendicular lean mass as determined by dual energy X-ray absorptiometry		Baseline, 3-months, 6-months	No
Secondary	Muscle volume as determined by magnetic resonance imaging		Baseline and 6-months	No
Secondary	Physical function as determined by questionnaire and a battery of physical performance tests		Baseline and 6 months	No