The Effect of β-hydroxy-β-methylbutyrate Supplementation on Physical Capacity and Body Composition in Trained Athletes

January 18, 2017 updated by: Krzysztof Durkalec-Michalski, Poznan University of Medical Sciences

The Effect of β-hydroxy-β-methylbutyrate (HMB) Supplementation on Physical Capacity and Body Composition in Trained Athletes

The purpose of this study was to verify the effect of 12-week with β-hydroxy-β-methylbutyrate (HMB) and a placebo (PLA) supplementation on body composition, anaerobic and aerobic capacity, as well as concentrations of the selected biochemical blood markers in trained athletes, in a randomised, double-blind, placebo-controlled crossover trial.

Study Overview

Detailed Description

The effect of HMB supplementation is of great interest in sport. In view of the inconclusive character of the results of the studies conducted to date and of a relatively low number of studies investigating the effectiveness of HMB supplementation over a longer period on a large population of trained athletes, the aim of this study was to verify the effect of 12-week with HMB and a placebo supplementation on body composition, anaerobic and aerobic capacity, as well as concentrations of the selected biochemical blood markers in trained athletes, in a randomised, double-blind, placebo-controlled crossover trial.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wielkopolska
      • Poznan, Wielkopolska, Poland, 60-624
        • Poznan University of Life Sciences, ul.Wojska Polskiego 31

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • written consent to participate,
  • male
  • a current medical clearance to practice sports,
  • training experience: at least 5 years,
  • minimum of 6 workout sessions a week (minimum 3 in the practiced sports discipline).

Exclusion Criteria:

  • current injury,
  • any health-related contraindication,
  • declared general feeling of being unwell,
  • unwilling to follow the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: β-hydroxy-β-methylbutyrate (HMB)

Group taking oral supplementation with calcium salt of β-hydroxy-β-methylbutyric acid produced by Olimp Laboratories. A single capsule contained 1250 mg Ca-HMB, which corresponds to 1000 mg of β-hydroxy-β-methylbutyrate.

Interventions:

The experimental procedure for each athlete included a 12-week HMB supplementation - 3 capsules of the assigned preparation a day in 3 doses: upon waking, immediately after training, and before sleep. On non-training days, the participants were instructed to consume one serving with each of three separate meals throughout the day.

Between the 12-week HMB and PLA or a PLA and HMB treatment, a 10-day washout period was introduced.

Placebo Comparator: Placebo (maltodextrin)

Group taking oral supplementation with placebo (maltodextrin). A single capsule contained 1000 mg of maltodextrin.

Interventions:

The experimental procedure for each athlete included a 12-week placebo administration - 3 capsules of the assigned preparation a day in 3 doses: upon waking, immediately after training, and before sleep. On non-training days, the participants were instructed to consume one serving with each of three separate meals throughout the day.

Between the 12-week HMB and PLA or a PLA and HMB treatment, a 10-day washout period was introduced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of body composition indices after HMB supplementation
Time Frame: Baseline and after 12 weeks
Analysis of the fat mass and fat free mass
Baseline and after 12 weeks
Changes of body composition indices after placebo treatment
Time Frame: Baseline and after 12 weeks
Analysis of the fat mass and fat free mass
Baseline and after 12 weeks
Changes of aerobic capacity after HMB supplementation
Time Frame: Baseline and after 12 weeks
Baseline and after 12 weeks
Changes of aerobic capacity after placebo treatment
Time Frame: Baseline and after 12 weeks
Baseline and after 12 weeks
Changes of anaerobic capacity after HMB supplementation
Time Frame: Baseline and after 12 weeks
Baseline and after 12 weeks
Changes of anaerobic capacity after placebo treatment
Time Frame: Baseline and after 12 weeks
Baseline and after 12 weeks
Changes of creatine kinase and lactate dehydrogenase activity in blood after HMB supplementation
Time Frame: Baseline and after 12 weeks
Baseline and after 12 weeks
Changes of creatine kinase and lactate dehydrogenase activity in blood after placebo treatment
Time Frame: Baseline and after 12 weeks
Baseline and after 12 weeks
Changes of testosterone, cortisol and lactate levels in blood after HMB supplementation
Time Frame: Baseline and after 12 weeks
Baseline and after 12 weeks
Changes of testosterone, cortisol and lactate levels in blood after placebo treatment
Time Frame: Baseline and after 12 weeks
Baseline and after 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Statistical evaluation of the significance of differences between the changes in aerobic capacity indices
Time Frame: 1 year
1 year
Statistical evaluation of the significance of differences between the changes in body composition (fat mass and fat free mass)
Time Frame: 1 year
1 year
Statistical evaluation of the significance of differences between the changes in anaerobic capacity indices
Time Frame: 1 year
1 year
Statistical evaluation of the significance of differences between the changes in creatine kinase and lactate dehydrogenase activity and testosterone, cortisol and lactate levels in blood
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jan Jeszka, Professor, Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Shared data will be exclusively related to the level recorded indicators (body composition, aerobic and anaerobic capacity indicators, levels of biochemical markers), without personal data. The data obtained will be attached to scientific publications, depending on the requirements of the journal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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