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

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.

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).

Study Overview

• Status: Completed
• Conditions: Muscle Damage
• Intervention / Treatment: Dietary supplement: Placebo; Procedure: cold water immersion; Dietary supplement: beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32816
      • University of Central Florida, Sport and Exercise Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Placebo supplement given prior to exercise and two times per day following exercise	Dietary supplement: Placebo
Experimental: cold water immersion; Placebo supplement to be give prior to exercise and two times per day following exercise in combination with cold water immersion therapy following exercise	Dietary supplement: Placebo; Procedure: cold water immersion
Experimental: HMB-FA; beta-hydroxy-beta-methylbutyrate free acid supplement to be give prior to exercise and two times per day following exercise	Dietary supplement: beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)
Experimental: cold water immersion group + HMB-FA; beta-hydroxy-beta-methylbutyrate free acid supplement give prior to exercise and two times per day following exercise in combination with cold water immersion therapy following exercise	Procedure: cold water immersion; Dietary supplement: beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal muscle strength	The 1-RM tests will be performed to assess maximal muscle strength.	Change from baseline over 48 hours post-exercise.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle damage	Serum creatine kinase and myoglobin concentrations will be analyzed as markers of muscle damage.	Change from baseline over 48 hours post-exercise.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
Immune Markers	Immune (IL-6, IL-10, Macrophage inflammatory protein-1β, tumor necrosis factor-α) markers will be analyzed.	Change from baseline over 48 hours post-exercise.
C-reactive protein	The Inflammatory marker, C-reactive protein, will be analyzed.	Change from baseline over 48 hours post-exercise.

Collaborators and Investigators

• Sponsor: Metabolic Technologies Inc.

Publications and helpful links

General Publications

• Ascensao A, Leite M, Rebelo AN, Magalhaes S, Magalhaes 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.
• Fuller JC Jr, Sharp RL, Angus HF, Baier SM, Rathmacher JA. Free acid gel form of beta-hydroxy-beta-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.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: February 13, 2013
• First Submitted That Met QC Criteria: February 14, 2013
• First Posted (Estimate): February 18, 2013

Study Record Updates

• Last Update Posted (Estimate): August 1, 2013
• Last Update Submitted That Met QC Criteria: July 31, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: MTI2013-CS01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No