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

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ClinicalTrials.gov Identifier: NCT03028649
Recruitment Status : Completed
First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Sponsor:
Collaborators:
Poznan University of Life Sciences
National Science Centre, Poland
Information provided by (Responsible Party):
Krzysztof Durkalec-Michalski, Poznan University of Medical Sciences

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
Sport Supplements Supplementation 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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028649


Locations
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Poland
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
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Study Chair: Jan Jeszka, Professor Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland
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Responsible Party: Krzysztof Durkalec-Michalski, Assistant Professor, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03028649    
Other Study ID Numbers: NN312262340
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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
Keywords provided by Krzysztof Durkalec-Michalski, Poznan University of Medical Sciences:
β-hydroxy-β-methylbutyric acid
Sport supplements
Training support
Adaptation