- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01941368
The Effects of β-Hydroxy-β-methylbutyrate Free Acid and High-Intensity Interval Training
The Effects of β-Hydroxy-β-methylbutyrate Free Acid Gel and High-Intensity Interval Training on Quadriceps Muscle Architecture and Quality, Neuromuscular Economy, and Metabolic Performance in Recreationally Trained Individuals
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Orlando, Florida, United States, 32816
- University of Central Florida, Sport and Exercise Science
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
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.
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Placebo Comparator: Placebo + High-Intesnity Interval Training (HIIT)
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).
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Active Comparator: HMB-FA + HIIT
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).
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2peak/Ventilatory Threshold/fatigue threshold
Time Frame: Change from baseline after four weeks of high intensity interval training
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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.
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Change from baseline after four weeks of high intensity interval training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EMG Activity Assessment
Time Frame: Change from baseline after four weeks of high intensity interval training
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To assess EMG activity, a bipolar surface electrode arrangement will be placed over the muscles of the quadriceps.
The EMG signals will be expressed as root mean square (RMS) amplitude values.
During the leg extensor trial, electromyography (EMG) root mean square (RMS) amplitude values will be recorded
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Change from baseline after four weeks of high intensity interval training
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultrasonography
Time Frame: Change from baseline after four weeks of high intensity interval training
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Skeletal muscle images will be collected of the thigh muscles.
These images will provide an ability to rate the quality of the leg muscles and determine the physiological cross-sectional area of the muscle
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Change from baseline after four weeks of high intensity interval training
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Three-minute Critical Power test
Time Frame: Change from baseline four weeks of high intensity interval training
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The participant will have 60 seconds of unloaded cycling at 90 rpm, followed by an all-out three-minute effort with resistance being set as a function of pedaling rate.
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Change from baseline four weeks of high intensity interval training
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Maximal Isometric Strength
Time Frame: Change from baseline after four weeks of high intensity interval training
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To obtain the maximum isometric strength (kilograms) participants will be positioned in a BioDex S4 isometric dynamometer in a seated position.
The participants will then be instructed to exert their maximum strength when trying to extend the knee and to produce the strength as fast as possible.
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Change from baseline after four weeks of high intensity interval training
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeffery Stout, PhD, University of Central Florida
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MTI2013-CS03
- 13-257 (Other Identifier: University of Central Florida)
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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