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Completed

NCT Number: NCT01150526

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.

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Key information

Conditions

Healthy Muscular Diseases Musculoskeletal Diseases Myositis Myositis, Inclusion Body Nervous System Diseases Neuromuscular Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Iowa State University

Ames, Iowa, 50010, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CaHMB

Dietary Supplement

CaHMB capsules with each capsule containing 0.8 g of HMB

HMB Free Acid Gel

Dietary Supplement

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

Placebo

Dietary Supplement

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

Placebo Gel Dosage

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Metabolic Technologies Inc.

Industry

Collaborators

  • Iowa State University

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2012
First posted
Jun 25, 2010
Registry last updated
Jul 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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