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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03028649
Other study ID # NN312262340
Secondary ID
Status Completed
Phase Phase 3
First received January 11, 2017
Last updated January 18, 2017
Start date January 2010
Est. completion date February 2014

Study information

Verified date January 2017
Source Poznan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 17 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
Poland Poznan University of Life Sciences, ul.Wojska Polskiego 31 Poznan Wielkopolska

Sponsors (3)

Lead Sponsor Collaborator
Poznan University of Medical Sciences National Science Centre, Poland, Poznan University of Life Sciences, Poznan, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of body composition indices after HMB supplementation Analysis of the fat mass and fat free mass Baseline and after 12 weeks
Primary Changes of body composition indices after placebo treatment Analysis of the fat mass and fat free mass Baseline and after 12 weeks
Primary Changes of aerobic capacity after HMB supplementation Baseline and after 12 weeks
Primary Changes of aerobic capacity after placebo treatment Baseline and after 12 weeks
Primary Changes of anaerobic capacity after HMB supplementation Baseline and after 12 weeks
Primary Changes of anaerobic capacity after placebo treatment Baseline and after 12 weeks
Primary Changes of creatine kinase and lactate dehydrogenase activity in blood after HMB supplementation Baseline and after 12 weeks
Primary Changes of creatine kinase and lactate dehydrogenase activity in blood after placebo treatment Baseline and after 12 weeks
Primary Changes of testosterone, cortisol and lactate levels in blood after HMB supplementation Baseline and after 12 weeks
Primary Changes of testosterone, cortisol and lactate levels in blood after placebo treatment Baseline and after 12 weeks
Secondary Statistical evaluation of the significance of differences between the changes in body composition (fat mass and fat free mass) 1 year
Secondary Statistical evaluation of the significance of differences between the changes in aerobic capacity indices 1 year
Secondary Statistical evaluation of the significance of differences between the changes in anaerobic capacity indices 1 year
Secondary 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
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