NCT01941368

Brief Summary

Objectives: 1) Determine the effect of 4-weeks of high intensity interval training (HIIT) and free acid form β-Hydroxy-β-methylbutyrate (HMB-FA) on VO2peak, lactate threshold, critical power, anaerobic working capacity and neuromuscular economy in a population of endurance trained individuals. 2) Determine the effect of 4-weeks of HIIT and HMB-FA on changes in skeletal muscle physiological cross-sectional area (PCSA=Volume/Fascicle length) and muscle quality (MQ=echo intensity) in the rectus femoris and vastus lateralis. Subjects: Fifty males and females between the ages of 18 - 35 will be recruited to participate in this study. Subject will be randomized to one of three groups: a control group (CTL), an HIIT only group (HIIT) or a group which will take the amino acid metabolite HMB and perform HIIT (HMB-HIIT). Individuals assigned to CTL will undergo baseline testing. They will then be asked to continue their normal exercise routine for 4 weeks and will undergo post-testing after this time period. Study Protocol: Two testing sessions, on nonconsecutive days, will occur at least 72 hours prior to the start of the training period. The same testing protocols will be repeated at the end of the 4-week training period. Testing protocols include performance testing (VO2peak, lactate threshold, critical power, anaerobic working capacity and neuromuscular economy) and anthropometric measures (physiological cross-sectional area and muscle quality). The training protocol for individuals in the experimental groups will consist of 4-weeks of high intensity interval training with three sessions per week on an electronically braked cycle ergometer. Individual work -loads will be calculated based on the outcomes from each participant's preliminary testing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

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

September 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

3 months

First QC Date

September 4, 2013

Last Update Submit

March 14, 2014

Conditions

Keywords

PerformanceAerobic Exercise

Outcome Measures

Primary Outcomes (1)

  • VO2peak/Ventilatory Threshold/fatigue threshold

    A continuous graded exercise test will be performed on an electronically-braked cycle ergometer to determine maximal oxygen consumption (VO2peak) and the peak power output (PPO) in watts (W) at VO2peak.

    Change from baseline after four weeks of high intensity interval training

Secondary Outcomes (1)

  • EMG Activity Assessment

    Change from baseline after four weeks of high intensity interval training

Other Outcomes (3)

  • Ultrasonography

    Change from baseline after four weeks of high intensity interval training

  • Three-minute Critical Power test

    Change from baseline four weeks of high intensity interval training

  • Maximal Isometric Strength

    Change from baseline after four weeks of high intensity interval training

Study Arms (3)

Control

NO INTERVENTION

Individuals assigned to Control Group will undergo baseline testing and then be asked to continue their normal exercise routine for 4 weeks and will undergo post-testing (visits 16 and 17) after this time period.

Placebo + High-Intesnity Interval Training (HIIT)

PLACEBO COMPARATOR

On training days, individuals will consume 1 gram of placebo 30 min prior to training, 1gram placebo 1 hour post training, and 1gram placebo 3 hours post training. On non-training days, individuals will consume placebo 3 times per day (8am, 12pm and 4pm).

Dietary Supplement: PlaceboProcedure: High Intensity Interval Training

HMB-FA + HIIT

ACTIVE COMPARATOR

On training days, individuals will consume 1 gram HMB-FA 30 min prior to training, 1gram HMB-FA 1 hour post training, and 1gram HMB-FA 3 hours post training. On non-training days, individuals will consume HMB-FA 3 times per day (8am, 12pm and 4pm).

Dietary Supplement: HMB-FAProcedure: High Intensity Interval Training

Interventions

PlaceboDIETARY_SUPPLEMENT
Placebo + High-Intesnity Interval Training (HIIT)
HMB-FADIETARY_SUPPLEMENT
Also known as: beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)
HMB-FA + HIIT
HMB-FA + HIITPlacebo + High-Intesnity Interval Training (HIIT)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Recreationally-trained individuals with a VO2peak\>40 ml∙kg-1∙min-1.
  • Free of any physical limitations as determined by the Confidential Medical and Activity questionnaire and/or PAR-Q
  • Between the ages of 18 and 35

You may not qualify if:

  • Inability to perform physical exercise, as determined by the Confidential Medical and Activity questionnaire and/or PAR-Q
  • Any chronic illness that causes continuous medical care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida, Sport and Exercise Science

Orlando, Florida, 32816, United States

Location

Related Publications (1)

  • Robinson EH 4th, Stout JR, Miramonti AA, Fukuda DH, Wang R, Townsend JR, Mangine GT, Fragala MS, Hoffman JR. High-intensity interval training and beta-hydroxy-beta-methylbutyric free acid improves aerobic power and metabolic thresholds. J Int Soc Sports Nutr. 2014 Apr 26;11:16. doi: 10.1186/1550-2783-11-16. eCollection 2014.

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jeffery Stout, PhD

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2013

First Posted

September 13, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 17, 2014

Record last verified: 2014-03

Locations