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NCT01150526

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

NCT ID: NCT01150526

Last Updated: 2012-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Healthy

Keywords

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Acute Exercise Muscle Inflammation CaHMB HMB Free Acid Gel Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Placebo Gel Dosage

Intervention Type DIETARY_SUPPLEMENT

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

CaHMB Pre

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.

Group Type EXPERIMENTAL

CaHMB

Intervention Type DIETARY_SUPPLEMENT

CaHMB capsules with each capsule containing 0.8 g of HMB

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Placebo Gel Dosage

Intervention Type DIETARY_SUPPLEMENT

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

CaHMB Pre and Post

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.

Group Type EXPERIMENTAL

CaHMB

Intervention Type DIETARY_SUPPLEMENT

CaHMB capsules with each capsule containing 0.8 g of HMB

Placebo Gel Dosage

Intervention Type DIETARY_SUPPLEMENT

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

HMB Free Acid Gel Pre

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.

Group Type EXPERIMENTAL

HMB Free Acid Gel

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Placebo Gel Dosage

Intervention Type DIETARY_SUPPLEMENT

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

HMB Free Acid Gel Pre and Post

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.

Group Type EXPERIMENTAL

HMB Free Acid Gel

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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CaHMB

CaHMB capsules with each capsule containing 0.8 g of HMB

Intervention Type DIETARY_SUPPLEMENT

HMB Free Acid Gel

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Placebo Gel Dosage

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Iowa State University

OTHER

Sponsor Role collaborator

Metabolic Technologies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John A Rathmacher, PhD

Role: PRINCIPAL_INVESTIGATOR

Metabolic Technologies Inc.

Locations

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Iowa State University

Ames, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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MTI2010-CS02

Identifier Type: -

Identifier Source: org_study_id