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NCT01150526 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Metabolic Technologies.

Completed
Registry status
Phase 1
Development phase
41
Enrollment target

NCT01150526: Completed Phase 1 study, sponsored by Metabolic Technologies.

NCT01150526 is a Phase 1 study that has completed, run by Metabolic Technologies. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01150526, a Phase 1 study, has completed, sponsored by Metabolic Technologies.

COMPLETED
Registry status
Phase 1
Development phase
41 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • DIETARY_SUPPLEMENT Placebo
  • DIETARY_SUPPLEMENT CaHMB
  • DIETARY_SUPPLEMENT HMB Free Acid Gel
  • DIETARY_SUPPLEMENT Placebo Gel Dosage

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2010-10
Est. Completion 2012-07
Phase Phase 1
Metabolic Technologies

16 total trials

What the finished NCT01150526 record still lists

NCT01150526 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01150526 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01150526 about?

NCT01150526 is a clinical study titled "Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate". 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...

What is the current status of trial NCT01150526?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2010-10. Estimated completion is 2012-07.

What interventions are being tested in trial NCT01150526?

The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), CaHMB (DIETARY_SUPPLEMENT), HMB Free Acid Gel (DIETARY_SUPPLEMENT), Placebo Gel Dosage (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01150526?

This trial is sponsored by Metabolic Technologies, which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01150526's enrollment target sits among peer trials

41 1125th of 2000 higher than 871 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01150526, the US trial registry maintained by the National Library of Medicine. NCT01150526 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.