Clinical trial 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Damage
Lead sponsor: Metabolic Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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).


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

Primary outcomes:
measure: Maximal muscle strength
timeFrame: Change from baseline over 48 hours post-exercise.
Secondary outcomes:
measure: Muscle damage
timeFrame: Change from baseline over 48 hours post-exercise.
Other outcomes:
measure: Muscle soreness
timeFrame: Change from baseline over 48-hours post-exercise.
measure: Lower body power
timeFrame: Change from baseline over 48 hours post-exercise.
measure: Immune Markers
timeFrame: Change from baseline over 48 hours post-exercise.
measure: C-reactive protein
timeFrame: Change from baseline over 48 hours post-exercise.
Locations:
city: Orlando
country: United States
facility: University of Central Florida, Sport and Exercise Science
state: Florida
Study officials:
References:
citation: 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.
citation: 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.