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 Overview
=================
Brief Summary
-----------------
Study Objectives 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. Compare HMB-FA + Cold water immersion to HMB-FA or cold water immersion. 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).

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.

Conditions
-----------------
Muscle Damage

Intervention / Treatment
-----------------
* Procedure: cold water immersion
* Dietary Supplement: beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Placebo supplement given prior to exercise and two times per day following exercise | Dietary Supplement: Placebo<br> <br> |
| Experimental: cold water immersion<br>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<br> <br> Dietary Supplement: Placebo<br> <br> |
| Experimental: HMB-FA<br>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)<br> <br> |
| Experimental: cold water immersion group + HMB-FA<br>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<br> <br> Dietary Supplement: beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)<br> <br> |

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. |