The Effects of β-Hydroxy-β-methylbutyrate Free Acid and High-Intensity Interval Training

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941368
• Other study ID #: MTI2013-CS03
• Secondary ID: 13-257
• Status: Completed
• Phase: N/A
• First received: September 4, 2013
• Last updated: March 14, 2014
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Metabolic Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Exercise

Intervention

Dietary Supplement:
• Placebo

• HMB-FA

Procedure:
• High Intensity Interval Training

Locations

Country	Name	City	State
United States	University of Central Florida, Sport and Exercise Science	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Metabolic Technologies Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ultrasonography	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	Change from baseline after four weeks of high intensity interval training	No
Other	Three-minute Critical Power test	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.	Change from baseline four weeks of high intensity interval training	No
Other	Maximal Isometric Strength	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.	Change from baseline after four weeks of high intensity interval training	No
Primary	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	No
Secondary	EMG Activity Assessment	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	Change from baseline after four weeks of high intensity interval training	No