Clinical trial NCT03028649: The Effect of β-hydroxy-β-methylbutyrate Supplementation on Physical Capacity and Body Composition in Trained Athletes
Official title: The Effect of β-hydroxy-β-methylbutyrate (HMB) Supplementation on Physical Capacity and Body Composition in Trained Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sport
Supplements
Supplementation
Keywords: β-hydroxy-β-methylbutyric acid
Sport supplements
Training support
Adaptation
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Poznan University of Life Sciences
name: National Science Centre, Poland
First posted: 2017-01-23
Enrollment: 58
Sex: MALE
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes of body composition indices after HMB supplementation
timeFrame: Baseline and after 12 weeks
measure: Changes of body composition indices after placebo treatment
timeFrame: Baseline and after 12 weeks
measure: Changes of aerobic capacity after HMB supplementation
timeFrame: Baseline and after 12 weeks
measure: Changes of aerobic capacity after placebo treatment
timeFrame: Baseline and after 12 weeks
measure: Changes of anaerobic capacity after HMB supplementation
timeFrame: Baseline and after 12 weeks
measure: Changes of anaerobic capacity after placebo treatment
timeFrame: Baseline and after 12 weeks
measure: Changes of creatine kinase and lactate dehydrogenase activity in blood after HMB supplementation
timeFrame: Baseline and after 12 weeks
measure: Changes of creatine kinase and lactate dehydrogenase activity in blood after placebo treatment
timeFrame: Baseline and after 12 weeks
measure: Changes of testosterone, cortisol and lactate levels in blood after HMB supplementation
timeFrame: Baseline and after 12 weeks
measure: Changes of testosterone, cortisol and lactate levels in blood after placebo treatment
timeFrame: Baseline and after 12 weeks
Secondary outcomes:
measure: Statistical evaluation of the significance of differences between the changes in body composition (fat mass and fat free mass)
timeFrame: 1 year
measure: Statistical evaluation of the significance of differences between the changes in aerobic capacity indices
timeFrame: 1 year
measure: Statistical evaluation of the significance of differences between the changes in anaerobic capacity indices
timeFrame: 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
timeFrame: 1 year
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Life Sciences, ul.Wojska Polskiego 31
state: Wielkopolska
Study officials:
affiliation: Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland
name: Jan Jeszka, Professor
role: STUDY_CHAIR
References: