Physical EnduranceNCT02821481
Beta-alanine and Elder Endurance
A study testing Beta-alanine and Muscular endurance exercise in people with Physical Endurance, run by University of Miami at 1 site in United States.
Trial summary
The purpose for this study is to determine if beta-alanine supplementation combined with endurance-based resistance training can increase gains in muscular endurance to a greater extent than endurance-based resistance-training alone in older adults. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Endurance
- What is being tested?
- Beta-alanine and Muscular endurance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2016
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60-90 years of age
- Living independently (not residing in an assisted living facility)
- Through testing are found not to have sarcopenia
- Gait speed > 1 m/s
- Skeletal Muscle Index > 37% in men and > 27.6 % in women
Who cannot join
- Responding with a "yes" to any question on the PAR-Q.
- Are currently pregnant, or plan to try and become pregnant during the study
- Functional impairments that could impede the person's ability to participate in a resistance training program
- Current or recent use of supplements (within the past 3 months for non-alanine containing supplements or one year for supplements containing beta-alanine). Individuals taking only basic multivitamins (without any herbal co-ingredients) may still be allowed to participate. These situations will be reviewed on a case-by-case basis.
- Are currently enrolled in a regular exercise program (more than once per week)
- Current or recent smoker
Show all 16Show fewer
- Use of medication containing corticosteroids
- Mini-mental score of 21 or below
- Severe musculoskeletal impairment
- Uncontrolled chronic disease
- Major depression
- Severe vestibular problems
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Max Orovitz Laboratories
Coral Gables, Florida, 33146
About this study
Official title: The Interactive Effects Of Beta-Alanine Supplementation and Resistance Training on Muscular Endurance in Older Adults
The purpose for this study is to determine if beta-alanine supplementation combined with endurance-based resistance training can increase gains in muscular endurance to a greater extent than endurance-based resistance-training alone in older adults.
- Conditions
- Physical Endurance
- Being tested
- Beta-alanine, Placebo, Muscular endurance exercise
- Keywords
- Neuromuscular, Supplementation, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-alanineDietary supplement
PlaceboDietary supplement
Muscular endurance exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Beta-alanine and muscular endurance exercise | Experimental | Receive 3.2 g/day beta-alanine and 3 days per week of endurance resistance training for 12 weeks Receives: Dietary Supplement: Beta-alanine; Behavioral: Muscular endurance exercise |
| Beta-alanine without muscular endurance training | Experimental | Receive 3.2 g/day beta-alanine with no endurance resistance training for 12 weeks Receives: Dietary Supplement: Beta-alanine |
| Placebo and muscular endurance exercise | Placebo comparator | Receive similar dextrose placebo and 3 days per week of endurance resistance training for 12 weeks Receives: Dietary Supplement: Placebo; Behavioral: Muscular endurance exercise |
| Placebo without muscular endurance training | Placebo comparator | Receive similar dextrose placebo with no endurance resistance training for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Performance of Daily Activities
Short Physical Functional Performance test
Measured: baseline, 12 weeks
Secondary outcomes (3)
Change in Body Fat
Body fat assessment via bioimpedance
Measured: baseline, 12 weeks
Change in Muscular Endurance
20 repetitions to measure decline in muscular power across repetitions
Measured: baseline, 12 weeks
Change in Muscular Strength
Maximal weight that could be lifted one time (1RM)
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical EnduranceStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Signorile, University of Miami
- Investigators
- Joseph F. Signorile, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821481
- Sponsor's protocol ID
- 20140412
- Status last verified
- Aug 2017
- First submitted
- 28 Jun 2016
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interactive Effects Of Beta-Alanine Supplementation and Resistance Training on Muscular Endurance in Older Adults
- ClinicalTrials.gov ID
- NCT02821481
- Acronym / sponsor ID
- 20140412
- Conditions
- Physical Endurance
- Keywords
- Neuromuscular, Supplementation, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Jul 2016 (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 for this study is to determine if beta-alanine supplementation combined with endurance-based resistance training can increase gains in muscular endurance to a greater extent than endurance-based resistance-training alone in older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Beta-alanine and muscular endurance exercise | Experimental | Dietary Supplement: Beta-alanine, Behavioral: Muscular endurance exerciseReceive 3.2 g/day beta-alanine and 3 days per week of endurance resistance training for 12 weeks |
| Beta-alanine without muscular endurance training | Experimental | Dietary Supplement: Beta-alanineReceive 3.2 g/day beta-alanine with no endurance resistance training for 12 weeks |
| Placebo and muscular endurance exercise | Placebo comparator | Dietary Supplement: Placebo, Behavioral: Muscular endurance exerciseReceive similar dextrose placebo and 3 days per week of endurance resistance training for 12 weeks |
| Placebo without muscular endurance training | Placebo comparator | Dietary Supplement: PlaceboReceive similar dextrose placebo with no endurance resistance training for 12 weeks |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 60-90 years of age
- Living independently (not residing in an assisted living facility)
- Through testing are found not to have sarcopenia
- Gait speed > 1 m/s
- Skeletal Muscle Index > 37% in men and > 27.6 % in women
Key exclusion criteria (16 listed)
- Responding with a "yes" to any question on the PAR-Q.
- Are currently pregnant, or plan to try and become pregnant during the study
- Functional impairments that could impede the person's ability to participate in a resistance training program
- Current or recent use of supplements (within the past 3 months for non-alanine containing supplements or one year for supplements containing beta-alanine). Individuals taking only basic multivitamins (without any herbal co-ingredients) may still be allowed to participate. These situations will be reviewed on a case-by-case basis.
- Are currently enrolled in a regular exercise program (more than once per week)
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 |
|---|---|---|
| Beta-alanine | Dietary supplement | Beta-alanine and muscular endurance exercise, Beta-alanine without muscular endurance training |
| Placebo | Dietary supplement | Placebo and muscular endurance exercise, Placebo without muscular endurance training |
| Muscular endurance exercise | Behavioural | Beta-alanine and muscular endurance exercise, Placebo and muscular endurance exercise |
Primary outcome
Change in Performance of Daily Activities
Time frame: baseline, 12 weeks
Short Physical Functional Performance test
3 secondary outcomes
Change in Body Fat
Time frame: baseline, 12 weeks
Change in Muscular Endurance
Time frame: baseline, 12 weeks
Change in Muscular Strength
Time frame: baseline, 12 weeks
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 5 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Joseph F. Signorile, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-alanine and Muscular endurance exercise in people with Physical Endurance, run by University of Miami 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 5 inclusion and 16 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 5 Sep 2017. 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?
Change in Performance of Daily Activities (time frame: baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2017; AzTrials last refreshed its copy on 2 Nov 2026.