Dietary Supplements and Aging Muscle

NCT ID: NCT01057082

Last Updated: 2012-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Juven

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

Group Type EXPERIMENTAL

Juven

Intervention Type 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.

Placebo

Group Type PLACEBO_COMPARATOR

Juven

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Amy Ellis

Registered Dietitian; Graduate Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy C Ellis, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29672184 (View on PubMed)

Other Identifiers

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F31AT005384-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F100107001

Identifier Type: -

Identifier Source: org_study_id

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