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

Metabolic Technologies

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Dietary Supplement: CaHMB; Dietary Supplement: Placebo Gel Dosage; Dietary Supplement: Placebo; Dietary Supplement: HMB Free Acid Gel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01150526

MTI2010-CS02

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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41 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo Gel Dosage

Dietary Supplement: Placebo

CaHMB Pre

Experimental group

Description:

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.

Treatment:

Dietary Supplement: CaHMB

Dietary Supplement: Placebo Gel Dosage

Dietary Supplement: Placebo

CaHMB Pre and Post

Experimental group

Description:

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.

Treatment:

Dietary Supplement: CaHMB

Dietary Supplement: Placebo Gel Dosage

HMB Free Acid Gel Pre

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Placebo Gel Dosage

Dietary Supplement: Placebo

Dietary Supplement: HMB Free Acid Gel

HMB Free Acid Gel Pre and Post

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: HMB Free Acid Gel