- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03028649
The Effect of β-hydroxy-β-methylbutyrate Supplementation on Physical Capacity and Body Composition in Trained Athletes
The Effect of β-hydroxy-β-methylbutyrate (HMB) Supplementation on Physical Capacity and Body Composition in Trained Athletes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Wielkopolska
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Poznan, Wielkopolska, Poland, 60-624
- Poznan University of Life Sciences, ul.Wojska Polskiego 31
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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. |
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of body composition indices after HMB supplementation
Time Frame: Baseline and after 12 weeks
|
Analysis of the fat mass and fat free mass
|
Baseline and after 12 weeks
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Changes of body composition indices after placebo treatment
Time Frame: Baseline and after 12 weeks
|
Analysis of the fat mass and fat free mass
|
Baseline and after 12 weeks
|
Changes of aerobic capacity after HMB supplementation
Time Frame: Baseline and after 12 weeks
|
Baseline and after 12 weeks
|
|
Changes of aerobic capacity after placebo treatment
Time Frame: Baseline and after 12 weeks
|
Baseline and after 12 weeks
|
|
Changes of anaerobic capacity after HMB supplementation
Time Frame: Baseline and after 12 weeks
|
Baseline and after 12 weeks
|
|
Changes of anaerobic capacity after placebo treatment
Time Frame: Baseline and after 12 weeks
|
Baseline and after 12 weeks
|
|
Changes of creatine kinase and lactate dehydrogenase activity in blood after HMB supplementation
Time Frame: Baseline and after 12 weeks
|
Baseline and after 12 weeks
|
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Changes of creatine kinase and lactate dehydrogenase activity in blood after placebo treatment
Time Frame: Baseline and after 12 weeks
|
Baseline and after 12 weeks
|
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Changes of testosterone, cortisol and lactate levels in blood after HMB supplementation
Time Frame: Baseline and after 12 weeks
|
Baseline and after 12 weeks
|
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Changes of testosterone, cortisol and lactate levels in blood after placebo treatment
Time Frame: Baseline and after 12 weeks
|
Baseline and after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Statistical evaluation of the significance of differences between the changes in aerobic capacity indices
Time Frame: 1 year
|
1 year
|
Statistical evaluation of the significance of differences between the changes in body composition (fat mass and fat free mass)
Time Frame: 1 year
|
1 year
|
Statistical evaluation of the significance of differences between the changes in anaerobic capacity indices
Time Frame: 1 year
|
1 year
|
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
|
1 year
|
Collaborators and Investigators
Investigators
- Study Chair: Jan Jeszka, Professor, Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NN312262340
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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