Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Metabolic Technologies Inc.
- Enrollment
- 41
- Locations
- 2
- Primary Endpoint
- Decrease in muscle damage and inflammation
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Time Frame: 4 days post eccentric exercise bout
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
Secondary Outcomes
- Improvement in strength recovery and decrease in soreness(4 days post eccentric exercise bout)