Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate

Metabolic Technologies Inc.41 enrolled

Overview

The proposed study will test efficacy of HMB in free acid gel to decrease muscle damage, diminish inflammatory response, and improve muscle strength recovery following an acute exercise stress. HMB in a free acid gel or in CaHMB capsule form will be administered as either a single dose before a bout of acute exercise or in multiple doses (one before and three daily doses for the 4 days following the acute exercise). We hypothesize that HMB in free acid gel will result in less muscle damage, diminished inflammatory response, and improved muscle strength recovery than either a placebo or CaHMB treatment following a bout of acute eccentric exercise. Our endpoints will include measurements of: (1) markers for muscle damage (CPK and LDH); (2) indicators of inflammation (CRP, TNF-α, IL-6, IL-1ra and IL-18); and (3) muscle strength recovery and soreness.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Must live within 50 miles of Ames, Iowa * Free of cardiac, liver, pulmonary, and kidney disease * Free of chronic inflammatory disease including rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, and psoriasis * Free diabetes mellitus * Not classified as morbidly obese (BMI must be less than 40) * Free of cardiac, liver, pulmonary, and kidney disease * No other serious medical illness * Normal menstrual cycle and not pregnant or lactating * Able to consume supplements and perform required exercise testing Exclusion Criteria: * Live more than 50 miles from Ames, Iowa * Presence of cardiac, liver, pulmonary, and kidney disease * Presence of chronic inflammatory disease including rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, and psoriasis * Diabetes mellitus * Classified as morbidly obese (BMI is greater than 40) * No other serious medical illness * Abnormal menstrual cycle, pregnant or lactating * Not able to consume supplements and perform required exercise testing

Outcomes

Primary Outcomes

Decrease in muscle damage and inflammation

Serum analysis for markers of muscle damage (CPK) and inflammation (IL-6, IL-18, IL1ra, TNF-a, CRP) will be measured at 24, 48, 72, and 96 h post exercise bout

Time frame: 4 days post eccentric exercise bout

Secondary Outcomes

Improvement in strength recovery and decrease in soreness

Muscle strength recovery and soreness will be measured at 24, 48, 72, and 96 h post exercise bout.