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Completed

NCT Number: NCT03028649

The Effect of β-hydroxy-β-methylbutyrate 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.

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Key information

Age range

17 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Poznan University of Life Sciences, ul.Wojska Polskiego 31

Poznan, Wielkopolska, 60-624, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

β-hydroxy-β-methylbutyrate and a placebo supplementation

Dietary Supplement

Primary outcomes

  1. Changes of body composition indices after HMB supplementation

    Time frame: Baseline and after 12 weeks

    Analysis of the fat mass and fat free mass

  2. Changes of body composition indices after placebo treatment

    Time frame: Baseline and after 12 weeks

    Analysis of the fat mass and fat free mass

  3. Changes of aerobic capacity after HMB supplementation

    Time frame: Baseline and after 12 weeks

  4. Changes of aerobic capacity after placebo treatment

    Time frame: Baseline and after 12 weeks

  5. Changes of anaerobic capacity after HMB supplementation

    Time frame: Baseline and after 12 weeks

  6. Changes of anaerobic capacity after placebo treatment

    Time frame: Baseline and after 12 weeks

  7. Changes of creatine kinase and lactate dehydrogenase activity in blood after HMB supplementation

    Time frame: Baseline and after 12 weeks

  8. Changes of creatine kinase and lactate dehydrogenase activity in blood after placebo treatment

    Time frame: Baseline and after 12 weeks

  9. Changes of testosterone, cortisol and lactate levels in blood after HMB supplementation

    Time frame: Baseline and after 12 weeks

  10. Changes of testosterone, cortisol and lactate levels in blood after placebo treatment

    Time frame: Baseline and after 12 weeks

Secondary outcomes

  1. Statistical evaluation of the significance of differences between the changes in body composition (fat mass and fat free mass)

    Time frame: 1 year

  2. Statistical evaluation of the significance of differences between the changes in aerobic capacity indices

    Time frame: 1 year

  3. Statistical evaluation of the significance of differences between the changes in anaerobic capacity indices

    Time frame: 1 year

  4. 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

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Collaborators

  • National Science Centre, Poland
  • Poznan University of Life Sciences

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2017
Registry last updated
Jan 23, 2017

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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