SupplementationPhase 2/3NCT05444959
The Impact of Exercise / Stress Stimuli on HMB Supplementation Efficacy
A Phase 2/3 study testing HMB supplementation in people with Supplementation and Sport, run by Poznan University of Physical Education at 2 sites in 2 countries.
Trial summary
The study aims at assessing the influence of β-hydroxy-β-methylbutyrate (HMB) free acid supplementation (90 mg/kg of fat free body mass/day) supplemented for 21 days on protein kinases activity and selected hormones levels, and subsequent improvements in muscle protein synthesis, lean body mass content and aerobic… Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Supplementation, Sport, Sports Nutrition
- What is being tested?
- HMB supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Sep 2021to 1 Jul 2025
- Phase
- Phase 2/3
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- written informed consent from all participants before the study
- a current medical clearance to practice sports,
- Group S: regular physical activity (> 250 minutes per week), training practice (> 10 years),
- Group W: a subjects characterized by lack of regular physical activity that never were trained in competitive sports and certain features of malnutrition/low physical fitness,
Who cannot join
- current injury,
- any health-related contraindication,
- declared general feeling of being unwell,
- unwilling to follow the study protocol,
- serious disease or metabolic problems,
- intake of ergogenic supplements 3 months before the beginning of the study,
Show all 9Show fewer
- history of anabolic androgenic steroids or drugs use that may interfere with muscle mass control (eg, corticosteroids), or affect physical performance,
- smoking and tobacco use,
- presence of infectious disease in the previous 4 weeks of the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Czechia1 site
Department of Physiology and Biochemisty at the Faculty of Physical Education and Sport (Charles University, Prague, Czech Republic)
Prague, Prague 6, 162 52
Poland1 site
Department of Sports Dietetics, Poznan University of Physical Education
Poznan, Wielkopolska, 61-871
About this study
Official title: Evaluation of the Impact of Exercise / Stress Stimuli on the Mechanisms and Efficacy of Beta-hydroxy-beta-methylbutyric Acid (HMB) in Trained and Malnourished Subjects
The study aims at assessing the influence of β-hydroxy-β-methylbutyrate (HMB) free acid supplementation (90 mg/kg of fat free body mass/day) supplemented for 21 days on protein kinases activity and selected hormones levels, and subsequent improvements in muscle protein synthesis, lean body mass content and aerobic capacity.
Read the detailed description
The main aim of the project is to assess the effects of 21 days of HMB (90 mg/kg of fat free body mass per day) or Placebo (PLA) supplementation under two distinct exercise/stress stimulus conditions in the groups of exercise trained participants (S group) and individuals showing features of malnutrition (W group) on the activity of Akt/PBK/mTOR/p70S6K and MAPK/ERK protein kinase pathway in peripheral blood mononuclear cells and muscle; blood concentrations of free and total testosterone, cortisol, IGF-1 and growth hormone; level of resting and exercise energy metabolism rate and alternations in energy sources utilization during exercise, as well as aerobic capacity and body composition.
The study is a double-blind, randomized, placebo-controlled, parallel-group trial. The study protocol consists of two 21-days supplementation periods. Within the first period of the trial the participants will follow their customary physical exercise (S group) / lifestyle (W group). In turn, in the second period of the trial the routine training (S group) or customary lifestyle (W group) will be supplemented twice a week with a functional training program, as a source of an additional exercise/stress stimulus.
Investigators aim to recruit 60 exercise trained individuals (S group) and 60 will be inactive individuals showing features of malnutrition (W group). Random allocation of participants to the HMB and PLA treatments will be done using a random sequence generator, with groups being equalised by fat-free mass level (within S group and W group separately).
At the first preliminary visit anthropometric measurements, and familiarization with exercise test procedures [i.e., incremental cycling test with ergorespirometry, maximal voluntary isometric contraction test (MVIC; performed in a Biodex isokinetic dynamometer)] will be performed. After the completion of the preliminary tests, the participants within S group and W group will be divided randomly into two treatments: 90mg/kgFFM per day of HMB or the same amount of PLA. There will be two 21-days supplementation periods differing in the type of exercise/stress stimulus of the organism.
Before the start of supplementation period (T1) and after their completion (T2 and T3) the series of testing procedures will be performed, each of the series will consist of one day. Each testing series (T1, T2, and T3) will include anthropometric measurements followed by pre-exercise (pre-Ex) blood collection (for the determination of the activity of signaling protein kinases in peripheral blood mononuclear cells; hormone concentrations: free and total testosterone, cortisol, IGF-1 and growth hormone; concentrations of alternative energy sources: ketone bodies <acetoacetate and beta-hydroxybutyrate> and free fatty acids; activity of selected enzymes: lactate dehydrogenase <LDH>, and creatine kinase <CK>; gasometric indices: pH, pCO2, pO2 and electrolytes: Ca2+, Na+, K+, Cl-; concentrations of other biochemical indices: myoglobin, urea, creatinine, glucose, lactate, bilirubins ), the m. vastus lateralis ultrasound and collection of the m. vastus lateralis samples using the percutaneous muscle microbiopsy technique (for the determination of the activity of signaling protein kinases). After the resting pre-Ex procedures, the ICT will be performed. Then the post-exercise (post-Ex) blood sampling and second muscle microbiopsy will be carried out. Finally, at the end of the procedures the MVIC will be assessed.
After collection all the data, comparisons between supplementation treatment conditions (HMB vs PLA) within groups and supplementation periods, as well as comparisons between studied groups (S group vs W group) within supplementation treatment and supplementation period will be performed using T-test for independent variables. Comparisons between supplementation periods within studied groups and supplementation treatment will be performed via T-test for dependent variables. Statistical analysis will be performed using Statistica v. 13.3, StatSoft Polska Sp. z o.o., 2022.
- Conditions
- Supplementation, Sport, Sports Nutrition, Sports Dietetics, Protein Kinases, Aerobic Capacity
- Being tested
- HMB supplementation, Placebo treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMB supplementationDietary supplement
Group taking oral HMB free acid supplementation in a blinded liquid form.
Placebo treatmentDietary supplement
Group taking oral supplementation with placebo (in a blinded liquid form).
| Study group | Role | What they receive |
|---|---|---|
| HMB supplementation | Experimental | The experimental procedure for each participant in this group includes a two 21-days periods HMB supplementation.
HMB will be administered in the form of blinded liquid containing 1 mL HMB free acid per 30 drops. The liquid HMB will be ingested with at least 100 mL of water. Each participant will ingest individualized dose of 90 mg HMB/kgFFM/day of liquid HMB free acid in a split dose per day. On training days in the S group during the first and the second period of supplementation and on training days in W group during the second period of supplementation the supplement will be taken before (half of the individual daily dose) and immediately after training session (second half of the individual daily dose), On rest days the supplements will be taken in the morning (half of the individual daily dose) and before bedtime (second half of the individual daily dose). Receives: Dietary Supplement: HMB supplementation |
| Placebo treatment | Placebo comparator | The experimental procedure for each participant in this group includes a two 21-days periods Placebo supplementation.
PLA (liquid placebo similar in appearance, taste and smell to HMB, but containing no HMB) will be placed in the blinded liquid form. PLA will be ingested with at least 100 mL of water. Each participant will ingest individualized dose of 90 mg PLA/kgFFM/day of liquid PLA in a split dose per day. On training days in the S group during the first and the second period of supplementation and on training days in W group during the second period of supplementation, the PLA will be taken before (half of the individual daily dose) and immediately after training session (second half of the individual daily dose), On rest days the PLA will be taken in the morning (half of the individual daily dose) and before bedtime (second half of the individual daily dose). Receives: Dietary Supplement: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the molecular potential after supplementation and exercises-induced stress stimuli on the organism
AKTser473, mTORSer2448, p70S7K1Thr389, 4E-BP1Ser65/Thr70, and 4EBP1Thr37/46 kinase activity (optical density)
Measured: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Secondary outcomes (12)
Changes in the muscle cholesterol and mevalonate content (in the vastus lateralis muscle samples) after supplementation and exercises-induced stress stimuli on the organism
Muscle cholesterol and mevalonate content (units)
Measured: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in blood concentrations of hormones: free and total testosterone, cortisol, IGF-1, growth hormone after supplementation and exercises-induced stress stimuli on the organism.
Blood free and total testosterone, cortisol, IGF-1, growth hormone content
Measured: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in creatine kinase (CK) and lactate dehydrogenase (LDH) activity (IU) in blood after supplementation and exercises-induced stress stimuli on the organism
CK and LDH activity (IU)
Measured: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in body mass and body mass composition after supplementation and exercises-induced stress stimuli on the organism
Body mass, fat free mass, fat mass (kg)
Measured: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in maximal oxygen uptake during the incremental cycling test after supplementation and exercises-induced stress stimuli on the organism
VO2max level (mL/min)
Measured: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in total body water content after supplementation and exercises-induced stress stimuli on the organism
Body water content (L)
Measured: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in other biochemical indices: myoglobin, urea, creatinine, glucose, lactate, bilirubins and electrolytes (Ca2+, Na+, K+, Cl-) after supplementation and exercises-induced stress stimuli on the organism
Blood concentrations of : myoglobin (mmol/L), urea (mmol/L), creatinine (mmol/L), glucose (mmol/L), lactate (mmol/L), bilirubins (mmol/L), and electrolytes [Ca2+, Na+, K+, Cl-] (mmol/L)
Measured: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in utilization of energy substrates during rest and physical exercise after supplementation and exercises-induced stress stimuli on the organism
Utilization of energy substrates - fats, carbohydrate and protein during rest and exercise (g/min)
Measured: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in resting and exercise energy expenditures after supplementation and exercises-induced stress stimuli on the organism
Energy expenditure during rest and exercise (kcal/min)
Measured: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in total daily energy expenditures after supplementation and exercises-induced stress stimuli on the organism
Daily energy expenditure (kcal/day)
Measured: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in specific exercise performance test Fight Gone Bad after supplementation and exercises-induced stress stimuli on the organism
Number of repetitions of five different exercise - sumo deadlift high-pulls, wall ball shots, box jumps, push press and rowing on an ergometer in each of three exercise rounds and total number of repetitions of all exercises of all exercise rounds (reps
Measured: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in the maximum voluntary isometric contraction (MVIC) after supplementation and exercises-induced muscle damage
Maximum voluntary isometric contraction (MVIC) torque (Nm)
Measured: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start10 Sep 2021
- Primary completion20 Dec 2024
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SupplementationStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Centre, Poland, Faculty of Physical Education and Sport at Charles University, Czech Republic, Poznan University of Life Sciences, Poznan University of Medical Sciences
- Responsible party
- Principal investigator, Krzysztof Durkalec-Michalski, Poznan University of Physical Education
- Investigators
- Krzysztof Durkalec-Michalski, Prof., PhD, Principal investigator, Department of Sports Dietetics, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444959
- Sponsor's protocol ID
- ZDS2022_0001
- Status last verified
- Sep 2025
- First submitted
- 12 Apr 2022
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Exercise / Stress Stimuli on the Mechanisms and Efficacy of Beta-hydroxy-beta-methylbutyric Acid (HMB) in Trained and Malnourished Subjects
- ClinicalTrials.gov ID
- NCT05444959
- Acronym / sponsor ID
- ZDS2022_0001
- Conditions
- Supplementation, Sport, Sports Nutrition, Sports Dietetics, Protein Kinases, Aerobic Capacity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Collaborators
- National Science Centre, Poland, Faculty of Physical Education and Sport at Charles University, Czech Republic, Poznan University of Life Sciences, Poznan University of Medical Sciences
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 6 Jul 2022 (actual)
- 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 study aims at assessing the influence of β-hydroxy-β-methylbutyrate (HMB) free acid supplementation (90 mg/kg of fat free body mass/day) supplemented for 21 days on protein kinases activity and selected hormones levels, and subsequent improvements in muscle protein synthesis, lean body mass content and aerobic capacity.
Detailed description
The main aim of the project is to assess the effects of 21 days of HMB (90 mg/kg of fat free body mass per day) or Placebo (PLA) supplementation under two distinct exercise/stress stimulus conditions in the groups of exercise trained participants (S group) and individuals showing features of malnutrition (W group) on the activity of Akt/PBK/mTOR/p70S6K and MAPK/ERK protein kinase pathway in peripheral blood mononuclear cells and muscle; blood concentrations of free and total testosterone, cortisol, IGF-1 and growth hormone; level of resting and exercise energy metabolism rate and alternations in energy sources utilization during exercise, as well as aerobic capacity and body composition.
The study is a double-blind, randomized, placebo-controlled, parallel-group trial. The study protocol consists of two 21-days supplementation periods. Within the first period of the trial the participants will follow their customary physical exercise (S group) / lifestyle (W group). In turn, in the second period of the trial the routine training (S group) or customary lifestyle (W group) will be supplemented twice a week with a functional training program, as a source of an additional exercise/stress stimulus.
Investigators aim to recruit 60 exercise trained individuals (S group) and 60 will be inactive individuals showing features of malnutrition (W group). Random allocation of participants to the HMB and PLA treatments will be done using a random sequence generator, with groups being equalised by fat-free mass level (within S group and W group separately).
At the first preliminary visit anthropometric measurements, and familiarization with exercise test procedures [i.e., incremental cycling test with ergorespirometry, maximal voluntary isometric contraction test (MVIC; performed in a Biodex isokinetic dynamometer)] will be performed. After the completion of the preliminary tests, the participants within S group and W group will be divided randomly into two treatments: 90mg/kgFFM per day of HMB or the same amount of PLA. There will be two 21-days supplementation periods differing in the type of exercise/stress stimulus of the organism.
Before the start of supplementation period (T1) and after their completion (T2 and T3) the series of testing procedures will be performed, each of the series will consist of one day. Each testing series (T1, T2, and T3) will include anthropometric measurements followed by pre-exercise (pre-Ex) blood collection (for the determination of the activity of signaling protein kinases in peripheral blood mononuclear cells; hormone concentrations: free and total testosterone, cortisol, IGF-1 and growth hormone; concentrations of alternative energy sources: ketone bodies <acetoacetate and beta-hydroxybutyrate> and free fatty acids; activity of selected enzymes: lactate dehydrogenase <LDH>, and creatine kinase <CK>; gasometric indices: pH, pCO2, pO2 and electrolytes: Ca2+, Na+, K+, Cl-; concentrations of other biochemical indices: myoglobin, urea, creatinine, glucose, lactate, bilirubins ), the m. vastus lateralis ultrasound and collection of the m. vastus lateralis samples using the percutaneous muscle microbiopsy technique (for the determination of the activity of signaling protein kinases). After the resting pre-Ex procedures, the ICT will be performed. Then the post-exercise (post-Ex) blood sampling and second muscle microbiopsy will be carried out. Finally, at the end of the procedures the MVIC will be assessed.
After collection all the data, comparisons between supplementation treatment conditions (HMB vs PLA) within groups and supplementation periods, as well as comparisons between studied groups (S group vs W group) within supplementation treatment and supplementation period will be performed using T-test for independent variables. Comparisons between supplementation periods within studied groups and supplementation treatment will be performed via T-test for dependent variables. Statistical analysis will be performed using Statistica v. 13.3, StatSoft Polska Sp. z o.o., 2022.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMB supplementation | Experimental | Dietary Supplement: HMB supplementationThe experimental procedure for each participant in this group includes a two 21-days periods HMB supplementation. HMB will be administered in the form of blinded liquid containing 1 mL HMB free acid per 30 drops. The liquid HMB will be ingested with at least 100 mL of water. Each participant will ingest individualized dose of 90 mg HMB/kgFFM/day of liquid HMB free acid in a split dose per day. On training days in the S group during the first and the second period of supplementation and on training days in W group during the second period of supplementation the supplement will be taken before (half of the individual daily dose) and immediately after training session (second half of the individual daily dose), On rest days the supplements will be taken in the morning (half of the individual daily dose) and before bedtime (second half of the individual daily dose). |
| Placebo treatment | Placebo comparator | Dietary Supplement: Placebo treatmentThe experimental procedure for each participant in this group includes a two 21-days periods Placebo supplementation. PLA (liquid placebo similar in appearance, taste and smell to HMB, but containing no HMB) will be placed in the blinded liquid form. PLA will be ingested with at least 100 mL of water. Each participant will ingest individualized dose of 90 mg PLA/kgFFM/day of liquid PLA in a split dose per day. On training days in the S group during the first and the second period of supplementation and on training days in W group during the second period of supplementation, the PLA will be taken before (half of the individual daily dose) and immediately after training session (second half of the individual daily dose), On rest days the PLA will be taken in the morning (half of the individual daily dose) and before bedtime (second half of the individual daily dose). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- written informed consent from all participants before the study
- a current medical clearance to practice sports,
- Group S: regular physical activity (> 250 minutes per week), training practice (> 10 years),
- Group W: a subjects characterized by lack of regular physical activity that never were trained in competitive sports and certain features of malnutrition/low physical fitness,
Key exclusion criteria (9 listed)
- current injury,
- any health-related contraindication,
- declared general feeling of being unwell,
- unwilling to follow the study protocol,
- serious disease or metabolic problems,
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 |
|---|---|---|
| HMB supplementationGroup taking oral HMB free acid supplementation in a blinded liquid form. | Dietary supplement | HMB supplementation |
| Placebo treatmentGroup taking oral supplementation with placebo (in a blinded liquid form). | Dietary supplement | Placebo treatment |
Primary outcome
Change in the molecular potential after supplementation and exercises-induced stress stimuli on the organism
Time frame: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
AKTser473, mTORSer2448, p70S7K1Thr389, 4E-BP1Ser65/Thr70, and 4EBP1Thr37/46 kinase activity (optical density)
12 secondary outcomes
Changes in the muscle cholesterol and mevalonate content (in the vastus lateralis muscle samples) after supplementation and exercises-induced stress stimuli on the organism
Time frame: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in blood concentrations of hormones: free and total testosterone, cortisol, IGF-1, growth hormone after supplementation and exercises-induced stress stimuli on the organism.
Time frame: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in creatine kinase (CK) and lactate dehydrogenase (LDH) activity (IU) in blood after supplementation and exercises-induced stress stimuli on the organism
Time frame: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in body mass and body mass composition after supplementation and exercises-induced stress stimuli on the organism
Time frame: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in maximal oxygen uptake during the incremental cycling test after supplementation and exercises-induced stress stimuli on the organism
Time frame: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in total body water content after supplementation and exercises-induced stress stimuli on the organism
Time frame: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in other biochemical indices: myoglobin, urea, creatinine, glucose, lactate, bilirubins and electrolytes (Ca2+, Na+, K+, Cl-) after supplementation and exercises-induced stress stimuli on the organism
Time frame: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in utilization of energy substrates during rest and physical exercise after supplementation and exercises-induced stress stimuli on the organism
Time frame: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in resting and exercise energy expenditures after supplementation and exercises-induced stress stimuli on the organism
Time frame: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in total daily energy expenditures after supplementation and exercises-induced stress stimuli on the organism
Time frame: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in specific exercise performance test Fight Gone Bad after supplementation and exercises-induced stress stimuli on the organism
Time frame: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
Changes in the maximum voluntary isometric contraction (MVIC) after supplementation and exercises-induced muscle damage
Time frame: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods
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 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Supplementation
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
Recruiting
Effects of Red Panax Ginseng Supplementation on Cognitive Performance and Emotional Well-Being in Young Healthy Adults
Mental Acuity
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
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.
Krzysztof Durkalec-Michalski, Prof., PhD principal investigator
Department of Sports Dietetics, Poznan University of Physical Education
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HMB supplementation in people with Supplementation and Sport, run by Poznan University of Physical Education at 2 sites in 2 countries.
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 4 inclusion and 9 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in the molecular potential after supplementation and exercises-induced stress stimuli on the organism (time frame: Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods). 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 2 Oct 2025.