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

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ClinicalTrials.gov Identifier: NCT01150526
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : July 18, 2012
Sponsor:
Collaborator:
Iowa State University
Information provided by (Responsible Party):
Metabolic Technologies Inc.

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 Type : Interventional  (Clinical Trial)
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 : October 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : July 2012

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




Primary Outcome Measures :
  1. Decrease in muscle damage and inflammation [ Time Frame: 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 :
  1. Improvement in strength recovery and decrease in soreness [ Time Frame: 4 days post eccentric exercise bout ]
    Muscle strength recovery and soreness will be measured at 24, 48, 72, and 96 h post exercise bout.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150526


Locations
United States, Iowa
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.

Responsible Party: Metabolic Technologies Inc.
ClinicalTrials.gov Identifier: NCT01150526     History of Changes
Other Study ID Numbers: MTI2010-CS02
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012

Keywords provided by Metabolic Technologies Inc.:
Acute Exercise
Muscle Inflammation
CaHMB
HMB Free Acid Gel
Healthy Subjects