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

Sponsor

Metabolic Technologies Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01150526

Collaborator

Iowa State University (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: CaHMB Dietary Supplement: HMB Free Acid Gel Dietary Supplement: Placebo Dietary Supplement: Placebo Gel Dosage	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	Dietary Supplement: Placebo Placebo capsules similar in size and color to the CaHMB capsules used in the study Dietary Supplement: Placebo Gel Dosage A corn syrup based placebo with flavoring and taste similar to the HMB Free Acid Gel
Experimental: 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.	Dietary Supplement: CaHMB CaHMB capsules with each capsule containing 0.8 g of HMB Dietary Supplement: Placebo Placebo capsules similar in size and color to the CaHMB capsules used in the study Dietary Supplement: Placebo Gel Dosage A corn syrup based placebo with flavoring and taste similar to the HMB Free Acid Gel
Experimental: 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.	Dietary Supplement: CaHMB CaHMB capsules with each capsule containing 0.8 g of HMB Dietary Supplement: Placebo Gel Dosage A corn syrup based placebo with flavoring and taste similar to the HMB Free Acid Gel
Experimental: 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.	Dietary Supplement: HMB Free Acid Gel HMB Free acid in a gel form with each dose supplying 0.8 g of HMB free acid Dietary Supplement: Placebo Placebo capsules similar in size and color to the CaHMB capsules used in the study Dietary Supplement: Placebo Gel Dosage A corn syrup based placebo with flavoring and taste similar to the HMB Free Acid Gel
Experimental: 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.	Dietary Supplement: HMB Free Acid Gel HMB Free acid in a gel form with each dose supplying 0.8 g of HMB free acid Dietary Supplement: Placebo Placebo capsules similar in size and color to the CaHMB capsules used in the study

Outcome Measures

Primary Outcome Measures

Decrease in muscle damage and inflammation [4 days post eccentric exercise bout]
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

Secondary Outcome Measures

Improvement in strength recovery and decrease in soreness [4 days post eccentric exercise bout]
Muscle strength recovery and soreness will be measured at 24, 48, 72, and 96 h post exercise bout.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iowa State University	Ames	Iowa	United States	50010

Sponsors and Collaborators

Metabolic Technologies Inc.
Iowa State University

Investigators

Principal Investigator: John A Rathmacher, PhD, Metabolic Technologies Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Metabolic Technologies Inc.

ClinicalTrials.gov Identifier:

NCT01150526

Other Study ID Numbers:

MTI2010-CS02

First Posted:

Jun 25, 2010

Last Update Posted:

Jul 18, 2012

Last Verified:

Jul 1, 2012

Keywords provided by Metabolic Technologies Inc.

Study Results

No Results Posted as of Jul 18, 2012