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NCT Number: NCT01793779

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

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).

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Key information

Conditions

Muscle Damage

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Florida, Sport and Exercise Science

Orlando, Florida, 32816, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold water immersion

Procedure

beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Metabolic Technologies Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 18, 2013
Registry last updated
Aug 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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