SarcopeniaNCT01057082
Dietary Supplements and Aging Muscle
A study testing Juven in people with Sarcopenia, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Juven
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Ages 65-89
- Ambulatory
Who cannot join
- Cognitive impairment
- History of renal or hepatic disease
- History of hypotension
- History of peripheral artery disease
- Uncontrolled hypertension
- Uncontrolled diabetes
Show all 10Show fewer
- Self-reported claustrophobia
- Current smoker
- Steroid or androgen use with the previous 3 months
- Individuals with pacemakers and defibrillators
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: 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.
- Conditions
- Sarcopenia
- Being tested
- Juven
- Keywords
- Sarcopenia, Aging, Muscle, Dietary Supplement, HMB, Arginine, Glutamine
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JuvenDietary 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.
JuvenDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Juven | Experimental | Participants in the treatment arm will receive the dietary supplement Juven. Receives: Dietary Supplement: Juven |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Juven |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat-free mass as determined by a four-compartment model of body composition
Measured: Baseline, 3-months, 6-months
Secondary outcomes (3)
Appendicular lean mass as determined by dual energy X-ray absorptiometry
Measured: Baseline, 3-months, 6-months
Muscle volume as determined by magnetic resonance imaging
Measured: Baseline and 6-months
Physical function as determined by questionnaire and a battery of physical performance tests
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Amy Ellis, University of Alabama at Birmingham
- Investigators
- Amy C Ellis, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057082
- Sponsor's protocol ID
- F100107001
- Other IDs
- F31AT005384-01
- Status last verified
- Mar 2012
- First submitted
- 26 Jan 2010
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 29672184
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Supplements and Aging Muscle: Specific Amino Acids to Combat Sarcopenia
- ClinicalTrials.gov ID
- NCT01057082
- Acronym / sponsor ID
- F100107001
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Aging, Muscle, Dietary Supplement, HMB, Arginine, Glutamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Feb 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Juven | Experimental | Dietary Supplement: JuvenParticipants in the treatment arm will receive the dietary supplement Juven. |
| Placebo | Placebo comparator | Dietary Supplement: Juven |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Ages 65-89
- Ambulatory
Key exclusion criteria (10 listed)
- Cognitive impairment
- History of renal or hepatic disease
- History of hypotension
- History of peripheral artery disease
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JuvenParticipants 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 |
| JuvenParticipants 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. | Dietary supplement | Placebo |
Primary outcome
Fat-free mass as determined by a four-compartment model of body composition
Time frame: Baseline, 3-months, 6-months
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
- Derived from this study: PubMed 29672184Ellis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy C Ellis, MPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juven in people with Sarcopenia, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat-free mass as determined by a four-compartment model of body composition (time frame: Baseline, 3-months, 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01057082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2012.