NCT02821481

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
Last Updated

September 5, 2017

Status Verified

August 1, 2017

Enrollment Period

Same day

First QC Date

June 28, 2016

Last Update Submit

August 31, 2017

Conditions

Physical Endurance

Keywords

NeuromuscularSupplementationElderly

Outcome Measures

Primary Outcomes (1)

  • Change in Performance of Daily Activities

    Short Physical Functional Performance test

    baseline, 12 weeks

Secondary Outcomes (3)

  • Change in Body Fat

    baseline, 12 weeks

  • Change in Muscular Endurance

    baseline, 12 weeks

  • Change in Muscular Strength

    baseline, 12 weeks

Study Arms (4)

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

Dietary Supplement: Beta-alanineBehavioral: 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

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

Dietary Supplement: PlaceboBehavioral: Muscular endurance exercise

Placebo without muscular endurance training

PLACEBO COMPARATOR

Receive similar dextrose placebo with no endurance resistance training for 12 weeks

Dietary Supplement: Placebo

Interventions

Beta-alanineDIETARY_SUPPLEMENT
Beta-alanine and muscular endurance exerciseBeta-alanine without muscular endurance training
PlaceboDIETARY_SUPPLEMENT
Placebo and muscular endurance exercisePlacebo without muscular endurance training
Muscular endurance exerciseBEHAVIORAL
Beta-alanine and muscular endurance exercisePlacebo and muscular endurance exercise

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Max Orovitz Laboratories

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Interventions

beta-Alanine

Intervention Hierarchy (Ancestors)

AlanineAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Joseph F. Signorile, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 1, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 5, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)