Clinical Trials Directory

Trials / Completed

CompletedNCT01150526

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
41 (actual)
Sponsor
Metabolic Technologies Inc. · Industry
Sex
All
Age
18 Years – 40 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTCaHMBCaHMB capsules with each capsule containing 0.8 g of HMB
DIETARY_SUPPLEMENTHMB Free Acid GelHMB Free acid in a gel form with each dose supplying 0.8 g of HMB free acid
DIETARY_SUPPLEMENTPlaceboPlacebo capsules similar in size and color to the CaHMB capsules used in the study
DIETARY_SUPPLEMENTPlacebo Gel DosageA corn syrup based placebo with flavoring and taste similar to the HMB Free Acid Gel

Timeline

Start date
2010-10-01
Primary completion
2010-11-01
Completion
2012-07-01
First posted
2010-06-25
Last updated
2012-07-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01150526. Inclusion in this directory is not an endorsement.