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 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Placebo Gel Dosage; Dietary supplement: CaHMB; Dietary supplement: HMB Free Acid Gel

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Ames, Iowa, United States, 50010
      • Iowa State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / 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: 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; Dietary supplement: CaHMB; CaHMB capsules with each capsule containing 0.8 g of HMB
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: Placebo Gel Dosage; A corn syrup based placebo with flavoring and taste similar to the HMB Free Acid Gel; Dietary supplement: CaHMB; CaHMB capsules with each capsule containing 0.8 g of HMB
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: 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; Dietary supplement: HMB Free Acid Gel; HMB Free acid in a gel form with each dose supplying 0.8 g of HMB free acid
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: Placebo; Placebo capsules similar in size and color to the CaHMB capsules used in 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in muscle damage and inflammation	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	4 days post eccentric exercise bout

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in strength recovery and decrease in soreness	Muscle strength recovery and soreness will be measured at 24, 48, 72, and 96 h post exercise bout.	4 days post eccentric exercise bout

Collaborators and Investigators

• Sponsor: Metabolic Technologies Inc.
• Collaborators: Iowa State University
• Investigators: Principal Investigator: John A Rathmacher, PhD, Metabolic Technologies Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: June 23, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (Estimate): June 25, 2010

Study Record Updates

• Last Update Posted (Estimate): July 18, 2012
• Last Update Submitted That Met QC Criteria: July 16, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Healthy Subjects; Acute Exercise; Muscle Inflammation; CaHMB; HMB Free Acid Gel
• Other Study ID Numbers: MTI2010-CS02