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

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: CaHMB
* Dietary Supplement: HMB Free Acid Gel
* Dietary Supplement: Placebo
* Dietary Supplement: Placebo Gel Dosage


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Exercise, Muscle Inflammation, CaHMB, HMB Free Acid Gel, Healthy Subjects