Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate
- Conditions
- Healthy
- Interventions
- Dietary Supplement: HMB Free Acid GelDietary Supplement: CaHMBDietary Supplement: Placebo Gel DosageDietary Supplement: Placebo
- Registration Number
- NCT01150526
- Lead Sponsor
- Metabolic Technologies Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CaHMB Pre and Post Placebo Gel Dosage Oral CaHMB capsule and one placebo gel dosage given 30 min prior to the acute exercise session. A CaHMB capsule and placebo gel dosage are are then administered 3 times daily during the remainder of the study. HMB Free Acid Gel Pre HMB Free Acid Gel Oral placebo capsule and one HMB free acid gel dosage given 30 min prior to the acute exercise session. A placebo capsule and placebo gel dosage are then administered 3 times daily during the remainder of the study. HMB Free Acid Gel Pre Placebo Oral placebo capsule and one HMB free acid gel dosage given 30 min prior to the acute exercise session. A placebo capsule and placebo gel dosage are then administered 3 times daily during the remainder of the study. HMB Free Acid Gel Pre Placebo Gel Dosage Oral placebo capsule and one HMB free acid gel dosage given 30 min prior to the acute exercise session. A placebo capsule and placebo gel dosage are then administered 3 times daily during the remainder of the study. HMB Free Acid Gel Pre and Post HMB Free Acid Gel Oral placebo capsule and one HMB free acid gel dosage given 30 min prior to the acute exercise session. A placebo capsule and HMB free acid gel dosage are then administered 3 times daily during the remainder of the study. HMB Free Acid Gel Pre and Post Placebo Oral placebo capsule and one HMB free acid gel dosage given 30 min prior to the acute exercise session. A placebo capsule and HMB free acid gel dosage are then administered 3 times daily during the remainder of the study. Placebo Placebo Oral Placebo capsule and one placebo gel dosage given 30 min prior to the acute exercise session. A placebo capsule and placebo gel dosage are then administered 3 times daily during the remainder of the study. Placebo Placebo Gel Dosage Oral Placebo capsule and one placebo gel dosage given 30 min prior to the acute exercise session. A placebo capsule and placebo gel dosage are then administered 3 times daily during the remainder of the study. CaHMB Pre CaHMB Oral CaHMB capsule and one placebo gel dosage given 30 min prior to the acute exercise session. A placebo capsule and placebo gel dosage are then administered 3 times daily during the remainder of the study. CaHMB Pre Placebo Oral CaHMB capsule and one placebo gel dosage given 30 min prior to the acute exercise session. A placebo capsule and placebo gel dosage are then administered 3 times daily during the remainder of the study. CaHMB Pre Placebo Gel Dosage Oral CaHMB capsule and one placebo gel dosage given 30 min prior to the acute exercise session. A placebo capsule and placebo gel dosage are then administered 3 times daily during the remainder of the study. CaHMB Pre and Post CaHMB Oral CaHMB capsule and one placebo gel dosage given 30 min prior to the acute exercise session. A CaHMB capsule and placebo gel dosage are are then administered 3 times daily during the remainder of the study.
- Primary Outcome Measures
Name Time Method Decrease in muscle damage and inflammation 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 Outcome Measures
Name Time Method Improvement in strength recovery and decrease in soreness 4 days post eccentric exercise bout Muscle strength recovery and soreness will be measured at 24, 48, 72, and 96 h post exercise bout.
Trial Locations
- Locations (1)
Iowa State University
🇺🇸Ames, Iowa, United States