NCT03708185

Brief Summary

The present study will seek to quantify whether a period of HIIT alongside β-alanine supplementation will improve the adaptation to training, and therefore performance, more than a period of HIIT alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2021

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

1.5 years

First QC Date

June 12, 2018

Last Update Submit

September 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline work done on a cycle ergometer in a cycling capacity test at 110%VO2max following a period of 4 weeks of beta-alanine supplementation and then 8 weeks of beta-alanine supplementation and high intensity interval training

    Subjects will have previously performed an incremental test to exhaustion (VO2max test). A work-load that corresponds to 110 % of the peak power output (Wmax) will be calculated, and participants will be asked to cycle at this power output until volitional exhaustion. This test will be preceded but a bout of 90-minute cycling at 65%VO2max. Tests will be performed on a Lode Excalibur Sport, and software linked to the bike will record data.

    At weeks 0, 4 and 12 of study.

Secondary Outcomes (9)

  • VO2max

    At weeks 0, 4, 8 and 12 of study.

  • Substrate utilisation

    At weeks 0, 4 and 12 of study.

  • Muscle carnosine concentration

    At weeks 0, 4 and 12 of study.

  • Muscle enzyme (citrate synthase, hexokinase, β-HAD, PFK) activity

    At weeks 0, 4 and 12 of study.

  • Muscle buffering capacity

    At weeks 0, 4 and 12 of study.

  • +4 more secondary outcomes

Study Arms (2)

HIIT + beta-alanine

EXPERIMENTAL

Participants will ingest an active supplement containing beta-alanine for a period of 12 weeks. During the last 8 weeks of that period, participants will take part in a structured program of high-intensity interval training.

Dietary Supplement: Beta-alanine

HIIT + placebo

EXPERIMENTAL

Participants will ingest a placebo supplement containing no beta-alanine for a period of 12 weeks. During the last 8 weeks of that period, participants will take part in a structured program of high-intensity interval training.

Dietary Supplement: Placebo

Interventions

Beta-alanineDIETARY_SUPPLEMENT

N/A: see arm description

HIIT + beta-alanine
PlaceboDIETARY_SUPPLEMENT

N/A: see arm description

HIIT + placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Moderately trained (vo2max: 50 - 60 ml/kg/min).
  • Females must be taking an oral contraceptive, or using a contraceptive implant.

You may not qualify if:

  • A recent history of musculoskeletal injury
  • Diagnosed cardiovascular or metabolic disease
  • Regular use of beta-alanine supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sport and Health Sciences

Exeter, Devon, EX4 4JA, United Kingdom

Location

MeSH Terms

Interventions

beta-Alanine

Intervention Hierarchy (Ancestors)

AlanineAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Andrew D Davenport, MSc

    The University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Doubly-blinded \& randomised using an online randomisation website.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2018

First Posted

October 17, 2018

Study Start

June 4, 2018

Primary Completion

December 20, 2019

Study Completion

June 28, 2021

Last Updated

September 30, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations