<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03028649</url>
  </required_header>
  <id_info>
    <org_study_id>NN312262340</org_study_id>
    <nct_id>NCT03028649</nct_id>
  </id_info>
  <brief_title>The Effect of β-hydroxy-β-methylbutyrate Supplementation on Physical Capacity and Body Composition in Trained Athletes</brief_title>
  <official_title>The Effect of β-hydroxy-β-methylbutyrate (HMB) Supplementation on Physical Capacity and Body Composition in Trained Athletes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poznan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Poznan University of Life Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Science Centre, Poland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Poznan University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to verify the effect of 12-week with β-hydroxy-β-methylbutyrate&#xD;
      (HMB) and a placebo (PLA) supplementation on body composition, anaerobic and aerobic&#xD;
      capacity, as well as concentrations of the selected biochemical blood markers in trained&#xD;
      athletes, in a randomised, double-blind, placebo-controlled crossover trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The effect of HMB supplementation is of great interest in sport. In view of the inconclusive&#xD;
      character of the results of the studies conducted to date and of a relatively low number of&#xD;
      studies investigating the effectiveness of HMB supplementation over a longer period on a&#xD;
      large population of trained athletes, the aim of this study was to verify the effect of&#xD;
      12-week with HMB and a placebo supplementation on body composition, anaerobic and aerobic&#xD;
      capacity, as well as concentrations of the selected biochemical blood markers in trained&#xD;
      athletes, in a randomised, double-blind, placebo-controlled crossover trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of body composition indices after HMB supplementation</measure>
    <time_frame>Baseline and after 12 weeks</time_frame>
    <description>Analysis of the fat mass and fat free mass</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of body composition indices after placebo treatment</measure>
    <time_frame>Baseline and after 12 weeks</time_frame>
    <description>Analysis of the fat mass and fat free mass</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of aerobic capacity after HMB supplementation</measure>
    <time_frame>Baseline and after 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of aerobic capacity after placebo treatment</measure>
    <time_frame>Baseline and after 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of anaerobic capacity after HMB supplementation</measure>
    <time_frame>Baseline and after 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of anaerobic capacity after placebo treatment</measure>
    <time_frame>Baseline and after 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of creatine kinase and lactate dehydrogenase activity in blood after HMB supplementation</measure>
    <time_frame>Baseline and after 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of creatine kinase and lactate dehydrogenase activity in blood after placebo treatment</measure>
    <time_frame>Baseline and after 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of testosterone, cortisol and lactate levels in blood after HMB supplementation</measure>
    <time_frame>Baseline and after 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of testosterone, cortisol and lactate levels in blood after placebo treatment</measure>
    <time_frame>Baseline and after 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Statistical evaluation of the significance of differences between the changes in body composition (fat mass and fat free mass)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Statistical evaluation of the significance of differences between the changes in aerobic capacity indices</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Statistical evaluation of the significance of differences between the changes in anaerobic capacity indices</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Sport</condition>
  <condition>Supplements</condition>
  <condition>Supplementation</condition>
  <arm_group>
    <arm_group_label>β-hydroxy-β-methylbutyrate (HMB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
Interventions:&#xD;
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.&#xD;
Between the 12-week HMB and PLA or a PLA and HMB treatment, a 10-day washout period was introduced.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (maltodextrin)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group taking oral supplementation with placebo (maltodextrin). A single capsule contained 1000 mg of maltodextrin.&#xD;
Interventions:&#xD;
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.&#xD;
Between the 12-week HMB and PLA or a PLA and HMB treatment, a 10-day washout period was introduced.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>β-hydroxy-β-methylbutyrate and a placebo supplementation</intervention_name>
    <arm_group_label>Placebo (maltodextrin)</arm_group_label>
    <arm_group_label>β-hydroxy-β-methylbutyrate (HMB)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written consent to participate,&#xD;
&#xD;
          -  male&#xD;
&#xD;
          -  a current medical clearance to practice sports,&#xD;
&#xD;
          -  training experience: at least 5 years,&#xD;
&#xD;
          -  minimum of 6 workout sessions a week (minimum 3 in the practiced sports discipline).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current injury,&#xD;
&#xD;
          -  any health-related contraindication,&#xD;
&#xD;
          -  declared general feeling of being unwell,&#xD;
&#xD;
          -  unwilling to follow the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Jeszka, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Poznan University of Life Sciences, ul.Wojska Polskiego 31</name>
      <address>
        <city>Poznan</city>
        <state>Wielkopolska</state>
        <zip>60-624</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Poznan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Krzysztof Durkalec-Michalski</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>β-hydroxy-β-methylbutyric acid</keyword>
  <keyword>Sport supplements</keyword>
  <keyword>Training support</keyword>
  <keyword>Adaptation</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_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</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03028649
org study id: NN312262340
nct id: NCT03028649
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Changes of body composition indices after HMB supplementation
time frame: Baseline and after 12 weeks
description: Analysis of the fat mass and fat free mass
measure: Changes of body composition indices after placebo treatment
time frame: Baseline and after 12 weeks
description: Analysis of the fat mass and fat free mass
measure: Changes of aerobic capacity after HMB supplementation
time frame: Baseline and after 12 weeks
measure: Changes of aerobic capacity after placebo treatment
time frame: Baseline and after 12 weeks
measure: Changes of anaerobic capacity after HMB supplementation
time frame: Baseline and after 12 weeks
measure: Changes of anaerobic capacity after placebo treatment
time frame: Baseline and after 12 weeks
measure: Changes of creatine kinase and lactate dehydrogenase activity in blood after HMB supplementation
time frame: Baseline and after 12 weeks
measure: Changes of creatine kinase and lactate dehydrogenase activity in blood after placebo treatment
time frame: Baseline and after 12 weeks
measure: Changes of testosterone, cortisol and lactate levels in blood after HMB supplementation
time frame: Baseline and after 12 weeks
measure: Changes of testosterone, cortisol and lactate levels in blood after placebo treatment
time frame: Baseline and after 12 weeks
measure: Statistical evaluation of the significance of differences between the changes in body composition (fat mass and fat free mass)
time frame: 1 year
measure: Statistical evaluation of the significance of differences between the changes in aerobic capacity indices
time frame: 1 year
measure: Statistical evaluation of the significance of differences between the changes in anaerobic capacity indices
time frame: 1 year
measure: 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
arm group label: β-hydroxy-β-methylbutyrate (HMB)
arm group type: Experimental
description: 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.
arm group label: Placebo (maltodextrin)
arm group type: Placebo Comparator
description: 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.
intervention type: Dietary Supplement
intervention name: β-hydroxy-β-methylbutyrate and a placebo supplementation
arm group label: Placebo (maltodextrin)
arm group label: β-hydroxy-β-methylbutyrate (HMB)
criteria: 
gender: Male
minimum age: 17 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Jeszka, Professor
role: Study Chair
affiliation: Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Poznan University of Medical Sciences
investigator full name: Krzysztof Durkalec-Michalski
investigator title: Assistant Professor
sharing ipd: Undecided
ipd 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