- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02821481
Beta-alanine and Elder Endurance
August 31, 2017 updated by: Joseph Signorile, University of Miami
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
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
-
-
Florida
-
Coral Gables, Florida, United States, 33146
- Max Orovitz Laboratories
-
-
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
60 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- Exclusion Criteria
- 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
- Use of medication containing corticosteroids
- Mini-mental score of 21 or below
- Severe musculoskeletal impairment
- Uncontrolled chronic disease
- Major depression
- Severe vestibular problems
Exclusion Criteria:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Beta-alanine and muscular endurance exercise
Receive 3.2 g/day beta-alanine and 3 days per week of endurance resistance training for 12 weeks
|
|
Experimental: Beta-alanine without muscular endurance training
Receive 3.2 g/day beta-alanine with no endurance resistance training for 12 weeks
|
|
Placebo Comparator: Placebo and muscular endurance exercise
Receive similar dextrose placebo and 3 days per week of endurance resistance training for 12 weeks
|
|
Placebo Comparator: Placebo without muscular endurance training
Receive similar dextrose placebo with no endurance resistance training for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Performance of Daily Activities
Time Frame: baseline, 12 weeks
|
Short Physical Functional Performance test
|
baseline, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Fat
Time Frame: baseline, 12 weeks
|
Body fat assessment via bioimpedance
|
baseline, 12 weeks
|
Change in Muscular Endurance
Time Frame: baseline, 12 weeks
|
20 repetitions to measure decline in muscular power across repetitions
|
baseline, 12 weeks
|
Change in Muscular Strength
Time Frame: baseline, 12 weeks
|
Maximal weight that could be lifted one time (1RM)
|
baseline, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph F. Signorile, PhD, University of Miami
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
June 1, 2016
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
June 28, 2016
First Submitted That Met QC Criteria
June 28, 2016
First Posted (Estimate)
July 1, 2016
Study Record Updates
Last Update Posted (Actual)
September 5, 2017
Last Update Submitted That Met QC Criteria
August 31, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20140412
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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