SportPhase 3NCT03028649
The Effect of β-hydroxy-β-methylbutyrate Supplementation on Physical Capacity and Body Composition in Trained Athletes
A Phase 3 study of Sport and Supplements, run by Poznan University of Medical Sciences at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 17 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sport, Supplements, Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2010to Feb 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 40 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- current injury,
- any health-related contraindication,
- declared general feeling of being unwell,
- unwilling to follow the study protocol.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Life Sciences, ul.Wojska Polskiego 31
Poznan, Wielkopolska, 60-624
About this study
Official title: The Effect of β-hydroxy-β-methylbutyrate (HMB) Supplementation on Physical Capacity and Body Composition in Trained Athletes
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.
Read the 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.
- Conditions
- Sport, Supplements, Supplementation
- Being tested
- β-hydroxy-β-methylbutyrate and a placebo supplementation
- Keywords
- β-hydroxy-β-methylbutyric acid, Sport supplements, Training support, Adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
β-hydroxy-β-methylbutyrate and a placebo supplementationDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| β-hydroxy-β-methylbutyrate (HMB) | Experimental | 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. Receives: Dietary Supplement: β-hydroxy-β-methylbutyrate and a placebo supplementation |
| Placebo (maltodextrin) | Placebo comparator | 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. Receives: Dietary Supplement: β-hydroxy-β-methylbutyrate and a placebo supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of body composition indices after HMB supplementation
Analysis of the fat mass and fat free mass
Measured: Baseline and after 12 weeks
Changes of body composition indices after placebo treatment
Analysis of the fat mass and fat free mass
Measured: Baseline and after 12 weeks
Changes of aerobic capacity after HMB supplementation
Measured: Baseline and after 12 weeks
Changes of aerobic capacity after placebo treatment
Measured: Baseline and after 12 weeks
Changes of anaerobic capacity after HMB supplementation
Measured: Baseline and after 12 weeks
Changes of anaerobic capacity after placebo treatment
Measured: Baseline and after 12 weeks
Changes of creatine kinase and lactate dehydrogenase activity in blood after HMB supplementation
Measured: Baseline and after 12 weeks
Changes of creatine kinase and lactate dehydrogenase activity in blood after placebo treatment
Measured: Baseline and after 12 weeks
Changes of testosterone, cortisol and lactate levels in blood after HMB supplementation
Measured: Baseline and after 12 weeks
Changes of testosterone, cortisol and lactate levels in blood after placebo treatment
Measured: Baseline and after 12 weeks
Secondary outcomes (4)
Statistical evaluation of the significance of differences between the changes in body composition (fat mass and fat free mass)
Measured: 1 year
Statistical evaluation of the significance of differences between the changes in aerobic capacity indices
Measured: 1 year
Statistical evaluation of the significance of differences between the changes in anaerobic capacity indices
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJan 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of Life Sciences, National Science Centre, Poland
- Responsible party
- Principal investigator, Krzysztof Durkalec-Michalski, Poznan University of Medical Sciences
- Investigators
- Jan Jeszka, Professor, Study chair, Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028649
- Sponsor's protocol ID
- NN312262340
- Status last verified
- Jan 2017
- First submitted
- 11 Jan 2017
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of β-hydroxy-β-methylbutyrate (HMB) Supplementation on Physical Capacity and Body Composition in Trained Athletes
- ClinicalTrials.gov ID
- NCT03028649
- Acronym / sponsor ID
- NN312262340
- Conditions
- Sport, Supplements, Supplementation
- Keywords
- β-hydroxy-β-methylbutyric acid, Sport supplements, Training support, Adaptation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Collaborators
- Poznan University of Life Sciences, National Science Centre, Poland
- Study start
- Jan 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| β-hydroxy-β-methylbutyrate (HMB) | Experimental | Dietary Supplement: β-hydroxy-β-methylbutyrate and a placebo supplementationGroup 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 (maltodextrin) | Placebo comparator | Dietary Supplement: β-hydroxy-β-methylbutyrate and a placebo supplementationGroup 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. |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- current injury,
- any health-related contraindication,
- declared general feeling of being unwell,
- unwilling to follow the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| β-hydroxy-β-methylbutyrate and a placebo supplementation | Dietary supplement | Placebo (maltodextrin), β-hydroxy-β-methylbutyrate (HMB) |
Primary outcome
Changes of body composition indices after HMB supplementation
Time frame: Baseline and after 12 weeks
Analysis of the fat mass and fat free mass
Changes of body composition indices after placebo treatment
Time frame: Baseline and after 12 weeks
Analysis of the fat mass and fat free mass
Changes of aerobic capacity after HMB supplementation
Time frame: Baseline and after 12 weeks
Changes of aerobic capacity after placebo treatment
Time frame: Baseline and after 12 weeks
Changes of anaerobic capacity after HMB supplementation
Time frame: Baseline and after 12 weeks
Changes of anaerobic capacity after placebo treatment
Time frame: 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
Changes of creatine kinase and lactate dehydrogenase activity in blood after placebo treatment
Time frame: Baseline and after 12 weeks
Changes of testosterone, cortisol and lactate levels in blood after HMB supplementation
Time frame: Baseline and after 12 weeks
Changes of testosterone, cortisol and lactate levels in blood after placebo treatment
Time frame: Baseline and after 12 weeks
4 secondary outcomes
Statistical evaluation of the significance of differences between the changes in body composition (fat mass and fat free mass)
Time frame: 1 year
Statistical evaluation of the significance of differences between the changes in aerobic capacity indices
Time frame: 1 year
Statistical evaluation of the significance of differences between the changes in anaerobic capacity indices
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Jeszka, Professor study chair
Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Sport and Supplements, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of body composition indices after HMB supplementation (time frame: Baseline and after 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.