Dietary Supplements and Aging Muscle

March 16, 2012 updated by: Amy Ellis, University of Alabama at Birmingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 89 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fat-free mass as determined by a four-compartment model of body composition
Time Frame: Baseline, 3-months, 6-months
Baseline, 3-months, 6-months

Secondary Outcome Measures

Outcome Measure
Time Frame
Appendicular lean mass as determined by dual energy X-ray absorptiometry
Time Frame: Baseline, 3-months, 6-months
Baseline, 3-months, 6-months
Muscle volume as determined by magnetic resonance imaging
Time Frame: Baseline and 6-months
Baseline and 6-months
Physical function as determined by questionnaire and a battery of physical performance tests
Time Frame: Baseline and 6 months
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Amy C Ellis, MPH, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 26, 2010

First Submitted That Met QC Criteria

January 26, 2010

First Posted (Estimate)

January 27, 2010

Study Record Updates

Last Update Posted (Estimate)

March 19, 2012

Last Update Submitted That Met QC Criteria

March 16, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F100107001
  • F31AT005384-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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