Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Oct 2010
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2010
CompletedFirst Posted
Study publicly available on registry
June 25, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJuly 18, 2012
July 1, 2012
1 month
June 23, 2010
July 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
4 days post eccentric exercise bout
Secondary Outcomes (1)
Improvement in strength recovery and decrease in soreness
4 days post eccentric exercise bout
Study Arms (5)
Placebo
PLACEBO COMPARATOROral 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
EXPERIMENTALOral 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
EXPERIMENTALOral 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
EXPERIMENTALOral 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
EXPERIMENTALOral 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.
Interventions
CaHMB capsules with each capsule containing 0.8 g of HMB
HMB Free acid in a gel form with each dose supplying 0.8 g of HMB free acid
Placebo capsules similar in size and color to the CaHMB capsules used in the study
A corn syrup based placebo with flavoring and taste similar to the HMB Free Acid Gel
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Metabolic Technologies Inc.lead
- Iowa State Universitycollaborator
Study Sites (1)
Iowa State University
Ames, Iowa, 50010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John A Rathmacher, PhD
Metabolic Technologies Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2010
First Posted
June 25, 2010
Study Start
October 1, 2010
Primary Completion
November 1, 2010
Study Completion
July 1, 2012
Last Updated
July 18, 2012
Record last verified: 2012-07