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

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ClinicalTrials.gov Identifier: NCT01793779
Recruitment Status : Completed
First Posted : February 18, 2013
Last Update Posted : August 1, 2013
Sponsor:
Information provided by (Responsible Party):
Metabolic Technologies Inc.

Brief 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).


Condition or disease Intervention/treatment Phase
Muscle Damage Procedure: cold water immersion Dietary Supplement: beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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.
Study Start Date : December 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

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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
Procedure: cold water immersion
Dietary Supplement: Placebo
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)



Primary Outcome Measures :
  1. Maximal muscle strength [ Time Frame: Change from baseline over 48 hours post-exercise. ]
    The 1-RM tests will be performed to assess maximal muscle strength.


Secondary Outcome Measures :
  1. Muscle damage [ Time Frame: Change from baseline over 48 hours post-exercise. ]
    Serum creatine kinase and myoglobin concentrations will be analyzed as markers of muscle damage.


Other Outcome Measures:
  1. Muscle soreness [ Time Frame: Change from baseline over 48-hours post-exercise. ]
    Subjects will be asked to rate their degree of lower body muscle soreness using a 15-cm visual analog scale (VAS).

  2. Lower body power [ Time Frame: Change from baseline over 48 hours post-exercise. ]
    Lower body power during the squat exercise protocol will be measured each repetition with a Tendo™ Power Output Unit.

  3. Immune Markers [ Time Frame: Change from baseline over 48 hours post-exercise. ]
    Immune (IL-6, IL-10, Macrophage inflammatory protein-1β, tumor necrosis factor-α) markers will be analyzed.

  4. C-reactive protein [ Time Frame: Change from baseline over 48 hours post-exercise. ]
    The Inflammatory marker, C-reactive protein, will be analyzed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793779


Locations
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United States, Florida
University of Central Florida, Sport and Exercise Science
Orlando, Florida, United States, 32816
Sponsors and Collaborators
Metabolic Technologies Inc.

Publications:
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Responsible Party: Metabolic Technologies Inc.
ClinicalTrials.gov Identifier: NCT01793779    
Other Study ID Numbers: MTI2013-CS01
First Posted: February 18, 2013    Key Record Dates
Last Update Posted: August 1, 2013
Last Verified: July 2013