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

Sponsor
Poznan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03028649
Collaborator
Poznan University of Life Sciences (Other), National Science Centre, Poland (Other)
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: β-hydroxy-β-methylbutyrate and a placebo supplementation
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of β-hydroxy-β-methylbutyrate (HMB) Supplementation on Physical Capacity and Body Composition in Trained Athletes
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

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.

Dietary Supplement: β-hydroxy-β-methylbutyrate and a placebo supplementation

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.

Dietary Supplement: β-hydroxy-β-methylbutyrate and a placebo supplementation

Outcome Measures

Primary Outcome Measures

  1. Changes of body composition indices after HMB supplementation [Baseline and after 12 weeks]

    Analysis of the fat mass and fat free mass

  2. Changes of body composition indices after placebo treatment [Baseline and after 12 weeks]

    Analysis of the fat mass and fat free mass

  3. Changes of aerobic capacity after HMB supplementation [Baseline and after 12 weeks]

  4. Changes of aerobic capacity after placebo treatment [Baseline and after 12 weeks]

  5. Changes of anaerobic capacity after HMB supplementation [Baseline and after 12 weeks]

  6. Changes of anaerobic capacity after placebo treatment [Baseline and after 12 weeks]

  7. Changes of creatine kinase and lactate dehydrogenase activity in blood after HMB supplementation [Baseline and after 12 weeks]

  8. Changes of creatine kinase and lactate dehydrogenase activity in blood after placebo treatment [Baseline and after 12 weeks]

  9. Changes of testosterone, cortisol and lactate levels in blood after HMB supplementation [Baseline and after 12 weeks]

  10. Changes of testosterone, cortisol and lactate levels in blood after placebo treatment [Baseline and after 12 weeks]

Secondary Outcome Measures

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

  2. Statistical evaluation of the significance of differences between the changes in aerobic capacity indices [1 year]

  3. Statistical evaluation of the significance of differences between the changes in anaerobic capacity indices [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 [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 40 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Poznan University of Life Sciences, ul.Wojska Polskiego 31 Poznan Wielkopolska Poland 60-624

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Krzysztof Durkalec-Michalski, Assistant Professor, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT03028649
Other Study ID Numbers:
  • NN312262340
First Posted:
Jan 23, 2017
Last Update Posted:
Jan 23, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Krzysztof Durkalec-Michalski, Assistant Professor, Poznan University of Medical Sciences

Study Results

No Results Posted as of Jan 23, 2017