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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01150526
Enrollment
41
Registered
2010-06-25
Start date
2010-10-31
Completion date
2012-07-31
Last updated
2012-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Acute Exercise, Muscle Inflammation, CaHMB, HMB Free Acid Gel, Healthy Subjects

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.

Interventions

DIETARY_SUPPLEMENTCaHMB

CaHMB capsules with each capsule containing 0.8 g of HMB

DIETARY_SUPPLEMENTHMB Free Acid Gel

HMB Free acid in a gel form with each dose supplying 0.8 g of HMB free acid

DIETARY_SUPPLEMENTPlacebo

Placebo capsules similar in size and color to the CaHMB capsules used in the study

DIETARY_SUPPLEMENTPlacebo Gel Dosage

A corn syrup based placebo with flavoring and taste similar to the HMB Free Acid Gel

Sponsors

Iowa State University
CollaboratorOTHER
Metabolic Technologies Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Decrease in muscle damage and inflammation4 days post eccentric exercise boutSerum 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

MeasureTime frameDescription
Improvement in strength recovery and decrease in soreness4 days post eccentric exercise boutMuscle strength recovery and soreness will be measured at 24, 48, 72, and 96 h post exercise bout.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026