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Dietary Supplements and Aging Muscle

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Juven
Juven
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Sarcopenia, Aging, Muscle, Dietary Supplement, HMB, Arginine, Glutamine

Eligibility Criteria

65 Years - 89 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Juven

Placebo

Arm Description

Participants in the treatment arm will receive the dietary supplement Juven.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Appendicular lean mass as determined by dual energy X-ray absorptiometry
Muscle volume as determined by magnetic resonance imaging
Physical function as determined by questionnaire and a battery of physical performance tests

Full Information

First Posted
January 26, 2010
Last Updated
March 16, 2012
Sponsor
University of Alabama at Birmingham
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01057082
Brief Title
Dietary Supplements and Aging Muscle
Official Title
Dietary Supplements and Aging Muscle: Specific Amino Acids to Combat Sarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Sarcopenia, Aging, Muscle, Dietary Supplement, HMB, Arginine, Glutamine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Juven
Arm Type
Experimental
Arm Description
Participants in the treatment arm will receive the dietary supplement Juven.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Juven
Intervention Description
Participants in the treatment arm will be asked to consume 2 packets of Juven drink mix each day for a period of six months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Juven
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fat-free mass as determined by a four-compartment model of body composition
Time Frame
Baseline, 3-months, 6-months
Secondary Outcome Measure Information:
Title
Appendicular lean mass as determined by dual energy X-ray absorptiometry
Time Frame
Baseline, 3-months, 6-months
Title
Muscle volume as determined by magnetic resonance imaging
Time Frame
Baseline and 6-months
Title
Physical function as determined by questionnaire and a battery of physical performance tests
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy C Ellis, MPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29672184
Citation
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.
Results Reference
derived

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Dietary Supplements and Aging Muscle

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