Comparison of Pre-exercise Beta-hydroxy-beta-methylbutyrate Free Acid (HMB-FA) and Cold Water Therapy for the Attenuation of Muscle Damage and Soreness

Muscle Damage Clinical Trial

Official title:

Comparison of Pre-exercise Beta-hydroxy-beta-methylbutyrate Free Acid (HMB-FA) and Cold Water Therapy for the Attenuation of Muscle Damage and Soreness in Experienced Resistance Trained Individuals.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793779
• Other study ID #: MTI2013-CS01
• Status: Completed
• Phase: N/A
• First received: February 13, 2013
• Last updated: July 31, 2013
• Start date: December 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: Metabolic Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Study Objectives

1. Compare beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) to cold water immersion on performance recovery from an acute bout of high intensity resistance exercise.

2. Compare HMB-FA + Cold water immersion to HMB-FA or cold water immersion.

3. Examine the effect of these recovery modalities on markers of muscle damage, inflammation and immune function.

Subjects

Subjects (men and women, 18 - 35 y) with at least one year of resistance training experience will be recruited. Subjects will be randomly divided into one of four groups: a cold water immersion group (CW), HMB-FA, CW+HMB-FA and a control group (CT).

Study Protocol

Subjects will report to the Human Performance Laboratory (HPL) on four separate occasions. On the first visit (T1) subjects will be tested for maximal strength [one repetition-maximum (1-RM)] on the squat, dead lift and barbell lunge exercises.] On their second visit (T2) subjects will perform a lower body resistance exercise session consisting of four sets of the squat, dead lift and barbell lunge exercises. All subjects will then report back to the HPL at 24- (T3) and 48-hours (T4) post-exercise. During T3 and T4, subjects will perform four sets of the squat exercise only using the same loading pattern and rest interval length as T2. Following the T2 and T3 workouts subjects in CT will undergo no treatment; subjects in CW will be required to sit in a whirlpool tub for 10-min up to their umbilicus in water at 50° F - 54° F (10° C - 12° C); subjects in HMB-FA will be provided the supplement 30 min prior each workout and CW+HMB-FA will be administered together at time points describe above.

Statistical Analysis

Statistical evaluation of performance and biochemical changes will be accomplished using a repeated measures analysis of variance (ANOVA).

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• At least one-year of resistance training experience

• Free of any physical limitations (determined by health and activity questionnaire).

• Between the ages of 18 and 35

Exclusion Criteria:

• Inability to perform physical exercise (determined by health and activity questionnaire)

• Taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire).

• Any chronic illness that causes continuous medical care

• Taking any type of prescription or over-the-counter medication, having any chronic illness causing you to seek medical care, pregnancy

Study Design

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

Related Conditions & MeSH terms

• Muscle Damage

Intervention

Procedure:
• cold water immersion

Dietary Supplement:
• beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)

• Placebo

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, 

References & Publications (2)

Ascensão A, Leite M, Rebelo AN, Magalhäes S, Magalhäes J. Effects of cold water immersion on the recovery of physical performance and muscle damage following a one-off soccer match. J Sports Sci. 2011 Feb;29(3):217-25. doi: 10.1080/02640414.2010.526132. — View Citation

Fuller JC Jr, Sharp RL, Angus HF, Baier SM, Rathmacher JA. Free acid gel form of ß-hydroxy-ß-methylbutyrate (HMB) improves HMB clearance from plasma in human subjects compared with the calcium HMB salt. Br J Nutr. 2011 Feb;105(3):367-72. doi: 10.1017/S0007114510003582. Epub 2010 Dec 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Muscle soreness	Subjects will be asked to rate their degree of lower body muscle soreness using a 15-cm visual analog scale (VAS).	Change from baseline over 48-hours post-exercise.	No
Other	Lower body power	Lower body power during the squat exercise protocol will be measured each repetition with a Tendo™ Power Output Unit.	Change from baseline over 48 hours post-exercise.	No
Other	Immune Markers	Immune (IL-6, IL-10, Macrophage inflammatory protein-1ß, tumor necrosis factor-a) markers will be analyzed.	Change from baseline over 48 hours post-exercise.	No
Other	C-reactive protein	The Inflammatory marker, C-reactive protein, will be analyzed.	Change from baseline over 48 hours post-exercise.	No
Primary	Maximal muscle strength	The 1-RM tests will be performed to assess maximal muscle strength.	Change from baseline over 48 hours post-exercise.	No
Secondary	Muscle damage	Serum creatine kinase and myoglobin concentrations will be analyzed as markers of muscle damage.	Change from baseline over 48 hours post-exercise.	No