SupplementationPhase 2/3NCT04549610
HMB and Exercise-induced Muscle Damage
A Phase 2/3 study testing HMB supplementation in people with Supplementation and Sport, run by Poznan University of Physical Education at 1 site in Brazil.
Trial summary
The study aims at assessing the influence of β-hydroxy-β-methylbutyrate (HMB) supplementation (4.0 g/day) supplemented for 7 days in a group of speed-strength trained individuals on lower-body strength performance, selected muscle histological, molecular and blood markers of muscle recovery in response to resistance… Read more about this study
- Who is it for?
- Ages 18 to 35 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
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2019to 1 Jan 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 18 to 35 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,
- training experience: at least 1 year strength training programs that include lower limbs,
- minimum of 3 workout sessions (strength/resistance training) a week,
- protein intake in customary diet and during the study protocol > 1.6g / kg of body mass per day,
- individual maximum strength greater than 2.5 times the body weight for the 1RM test in the leg-press.
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 creatine, caffeine or beta-alanine, or other 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
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Escola de Educação Física e Esporte da USP / School of Physical Education and Sport - USP.
São Paulo, São Paulo - SP, 05508-030
Guilherme G Artioli, Prof., PhD, +55 11 3091-8783, artioli@usp.br
Krzysztof Durkalec-Michalski, Prof., PhD
About this study
Official title: The Effect of β-hydroxy-β-methylbutyrate Supplementation on Muscle Damage Induced by Resistance Exercise
The study aims at assessing the influence of β-hydroxy-β-methylbutyrate (HMB) supplementation (4.0 g/day) supplemented for 7 days in a group of speed-strength trained individuals on lower-body strength performance, selected muscle histological, molecular and blood markers of muscle recovery in response to resistance exercise-induced muscle damage.
Read the detailed description
The main aim of the project is to assess the effects of seven days of HMB (4.0 g/day) or Placebo (PLA) supplementation on lower body strength performance, and functional, histological, clinical and molecular markers of muscle recovery after an acute resistance exercise session.
The study is a double-blind, randomized, placebo-controlled, parallel trial. 30 male participants will be divided randomly into two parallel groups: One group receiving 4.0 g/day HMB and the second group receiving PLA. Supplementation period (HMB or PLA) will be seven days (five days before and two days after muscle damage induced by an acute resistance training session). Food intake during the intervention will be assessed with the use of a food diary.
Before the start of the experimental protocol, the participants will be familiarized with all tests and procedures.
During the first visit, participants will be assessed for their anthropometric characteristics, and baseline blood samples will be collected for the analysis of the activity of muscle damage markers [creatine kinase (CK) and lactate dehydrogenase (LDH)]. We will then carry out the evaluation of the maximal voluntary isometric contraction (MVIC; performed in a Biodex isokinetic dynamometer), lower body maximum dynamic strength (1RM) for squat, leg press, and leg extension exercises. The participants will then return to the laboratory to repeat the same tests and confirm the obtained results (MVIC and 1RM tests).
On the third day, participants will take part in a resistance training session (RE3sets) to evaluate strength performance. We will monitor the maximum number of repetitions possible in three sets of three exercises (squats, the leg press, and leg extension), until the concentric failure, with a rest interval of two minutes per set. The workload will correspond to 80% of the individual's 1RM).
Participants will then spend five to seven days without any leg strength/power training, in order to facilitate effective recovery prior to the next main resistance exercises training (RE5sets), which will be designed to induce muscle damage. Furthermore, HMB or PLA supplementation will commence five days before RE5sets, and continue for 48 hours after RE5sets.
Before the RE5sets, a muscle biopsy will be done in the vastus lateralis for morphological analysis of the sarcomere integrity (histological analysis) and molecular testing (e.g. selected protein kinase activity (e.g. AKTser473, mTORSer2448, p70S7K1Thr389, 4E-BP1Ser65/Thr70, 4EBP1Thr37/46); muscle cholesterol, and mevalonate content). Blood samples will also be collected. After the biopsy, participants will carry out exercises similar to those performed in the preliminary studies, but will do 5 sets per exercise until concentric failure with a 2-min resting interval between sets and load corresponding to 80% of the participant's 1RM.
24 hours after the end of RE5sets, blood samples will be taken and the evaluation of the MVIC will be performed. 24 hours later (48 hours after the RE5sets), a muscle biopsy (for histological and molecular testing) will be conducted, and blood samples will be collected. Furthermore, the MVIC and RE3sets will also be measured.
Collected data will be compared between groups and times using mixed models (proc mixed, SAS v.9.3) followed by multiple comparisons of a hypothesis-driven single degree of freedom contrast analysis. The sample size was estimated at 24 in total, assuming an intra- and inter-subject interaction model, alpha level of 5%, power (1-β) of 0.8 and effect size 0.3 (small) (G*Power v.3.9.1.2). We will recruit a slightly larger number of participants (n = 30) to allow for the likely dropouts that will occur throughout the study. The level of significance adopted will be p <0.05.
- Conditions
- Supplementation, Sport, Sports Nutrition, Muscle Damage, Recovery
- 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 supplementation in a blinded capsule form.
Placebo treatmentDietary supplement
Group taking oral supplementation with placebo (corn starch) in a blinded capsule form.
| Study group | Role | What they receive |
|---|---|---|
| HMB supplementation | Experimental | The experimental procedure for each participant in this group includes a one week HMB supplementation.
HMB will be administered in the form of blinded capsules containing 0.5 g HMB per capsule. The capsules will be ingested with at least 250 mL of water. Each athlete will ingest 8 capsules (4 x 2 capsules) of HMB in a split dose per day. On training days the supplements will be taken in the morning (2 capsules), 1.5 hours before training session (2 capsules), immediately after training (2 capsules) and before sleep (2 capsules). On rest days the supplements will be taken in the morning (2 capsules), around midday (2 capsules), in the afternoon (2 capsules) and before bedtime (2 capsules) at possibly similar (approx. 4 hours) intervals during the day. Receives: Dietary Supplement: HMB supplementation |
| Placebo treatment | Placebo comparator | The experimental procedure for each participant in this group includes a one-week placebo (PLA) administration. PLA (corn starch) will be placed in the blinded capsules form. PLA will be ingested with at least 250 mL of water. Each participant in this group will ingest 8 placebo capsules a day. On training days the PLA capsules will be taken in the morning (2 capsules), 1.5 hours before training session (2 capsules), immediately after training (2 capsules) and before sleep (2 capsules). On rest days the supplements will be taken in the morning (2 capsules), around midday (2 capsules), in the afternoon (2 capsules) and before bedtime (2 capsules) at possibly similar (approx. 4 hours) intervals. Receives: Dietary Supplement: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the maximum voluntary isometric contraction (MVIC) after supplementation and exercises-induced muscle damage
Maximum voluntary isometric contraction (MVIC) torque (Nm)
Measured: Baseline, 24 hours and 48 hours after the end of exercises-induced muscle damage
Secondary outcomes (5)
Change in the histological sarcomere integrity (after biopsy of the vastus lateralis muscle samples) after supplementation and exercises-induced muscle damage
The disruption of the Z-line areas and the total visible fiber area in muscle fibers (%)
Measured: Baseline, 24 hours and 48 hours after the end of exercises-induced muscle damage
Change in the molecular potential (after biopsy of the vastus lateralis muscle samples) after supplementation and exercises-induced muscle damage
AKTser473, mTORSer2448, p70S7K1Thr389, 4E-BP1Ser65/Thr70, and 4EBP1Thr37/46 kinase activity (optical density)
Measured: Baseline, 24 hours and 48 hours after the end of exercises-induced muscle damage
Change in the muscle cholesterol and mevalonate content (in the vastus lateralis muscle samples) after supplementation and exercises-induced muscle damage
Muscle cholesterol and mevalonate content (units)
Measured: Baseline, 24 hours and 48 hours after the end of exercises-induced muscle damage
Changes in creatine kinase (CK) and lactate dehydrogenase (LDH) activity (IU) in blood after supplementation and exercises-induced muscle damage
CK and LDH activity (IU)
Measured: Baseline, 24 hours and 48 hours after the end of exercises-induced muscle damage
Change in the strength performance results (at 80% of the individual's 1RM) in three resistance exercises (squats, the leg press, and leg extension) before and after supplementation and exercises-induced muscle damage
Number of repetitions in each sets of squats, the leg press, and leg extension (reps)
Measured: Baseline and 48 hours after the end of exercises-induced muscle damage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Nov 2019
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- Escola de Educação Física e Esporte da Universidade de São Paulo (Brazil) - Parallel sponsor of the research, National Science Centre, Poland
- Responsible party
- Principal investigator, Krzysztof Durkalec-Michalski, Poznan University of Physical Education
- Investigators
- Guilherme G Artioli, Prof., PhD, Study chair, Applied Physiology & Nutrition Research Group, University of Sao Paulo. Sao Paulo, SP. Brazil.Krzysztof Durkalec-Michalski, Dr hab., PhD, Principal investigator, Department of Sports Dietetics, Poznan University of Physical Education, Poznań, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549610
- Sponsor's protocol ID
- ULS2020.001
- Status last verified
- Apr 2024
- First submitted
- 8 Sep 2020
- Last updated
- 23 Apr 2024
- 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 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of β-hydroxy-β-methylbutyrate Supplementation on Muscle Damage Induced by Resistance Exercise
- ClinicalTrials.gov ID
- NCT04549610
- Acronym / sponsor ID
- ULS2020.001
- Conditions
- Supplementation, Sport, Sports Nutrition, Muscle Damage, Recovery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Collaborators
- Escola de Educação Física e Esporte da Universidade de São Paulo (Brazil) - Parallel sponsor of the research, National Science Centre, Poland
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 16 Sep 2020 (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) supplementation (4.0 g/day) supplemented for 7 days in a group of speed-strength trained individuals on lower-body strength performance, selected muscle histological, molecular and blood markers of muscle recovery in response to resistance exercise-induced muscle damage.
Detailed description
The main aim of the project is to assess the effects of seven days of HMB (4.0 g/day) or Placebo (PLA) supplementation on lower body strength performance, and functional, histological, clinical and molecular markers of muscle recovery after an acute resistance exercise session.
The study is a double-blind, randomized, placebo-controlled, parallel trial. 30 male participants will be divided randomly into two parallel groups: One group receiving 4.0 g/day HMB and the second group receiving PLA. Supplementation period (HMB or PLA) will be seven days (five days before and two days after muscle damage induced by an acute resistance training session). Food intake during the intervention will be assessed with the use of a food diary.
Before the start of the experimental protocol, the participants will be familiarized with all tests and procedures.
During the first visit, participants will be assessed for their anthropometric characteristics, and baseline blood samples will be collected for the analysis of the activity of muscle damage markers [creatine kinase (CK) and lactate dehydrogenase (LDH)]. We will then carry out the evaluation of the maximal voluntary isometric contraction (MVIC; performed in a Biodex isokinetic dynamometer), lower body maximum dynamic strength (1RM) for squat, leg press, and leg extension exercises. The participants will then return to the laboratory to repeat the same tests and confirm the obtained results (MVIC and 1RM tests).
On the third day, participants will take part in a resistance training session (RE3sets) to evaluate strength performance. We will monitor the maximum number of repetitions possible in three sets of three exercises (squats, the leg press, and leg extension), until the concentric failure, with a rest interval of two minutes per set. The workload will correspond to 80% of the individual's 1RM).
Participants will then spend five to seven days without any leg strength/power training, in order to facilitate effective recovery prior to the next main resistance exercises training (RE5sets), which will be designed to induce muscle damage. Furthermore, HMB or PLA supplementation will commence five days before RE5sets, and continue for 48 hours after RE5sets.
Before the RE5sets, a muscle biopsy will be done in the vastus lateralis for morphological analysis of the sarcomere integrity (histological analysis) and molecular testing (e.g. selected protein kinase activity (e.g. AKTser473, mTORSer2448, p70S7K1Thr389, 4E-BP1Ser65/Thr70, 4EBP1Thr37/46); muscle cholesterol, and mevalonate content). Blood samples will also be collected. After the biopsy, participants will carry out exercises similar to those performed in the preliminary studies, but will do 5 sets per exercise until concentric failure with a 2-min resting interval between sets and load corresponding to 80% of the participant's 1RM.
24 hours after the end of RE5sets, blood samples will be taken and the evaluation of the MVIC will be performed. 24 hours later (48 hours after the RE5sets), a muscle biopsy (for histological and molecular testing) will be conducted, and blood samples will be collected. Furthermore, the MVIC and RE3sets will also be measured.
Collected data will be compared between groups and times using mixed models (proc mixed, SAS v.9.3) followed by multiple comparisons of a hypothesis-driven single degree of freedom contrast analysis. The sample size was estimated at 24 in total, assuming an intra- and inter-subject interaction model, alpha level of 5%, power (1-β) of 0.8 and effect size 0.3 (small) (G*Power v.3.9.1.2). We will recruit a slightly larger number of participants (n = 30) to allow for the likely dropouts that will occur throughout the study. The level of significance adopted will be p <0.05.
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 one week HMB supplementation. HMB will be administered in the form of blinded capsules containing 0.5 g HMB per capsule. The capsules will be ingested with at least 250 mL of water. Each athlete will ingest 8 capsules (4 x 2 capsules) of HMB in a split dose per day. On training days the supplements will be taken in the morning (2 capsules), 1.5 hours before training session (2 capsules), immediately after training (2 capsules) and before sleep (2 capsules). On rest days the supplements will be taken in the morning (2 capsules), around midday (2 capsules), in the afternoon (2 capsules) and before bedtime (2 capsules) at possibly similar (approx. 4 hours) intervals during the day. |
| Placebo treatment | Placebo comparator | Dietary Supplement: Placebo treatmentThe experimental procedure for each participant in this group includes a one-week placebo (PLA) administration. PLA (corn starch) will be placed in the blinded capsules form. PLA will be ingested with at least 250 mL of water. Each participant in this group will ingest 8 placebo capsules a day. On training days the PLA capsules will be taken in the morning (2 capsules), 1.5 hours before training session (2 capsules), immediately after training (2 capsules) and before sleep (2 capsules). On rest days the supplements will be taken in the morning (2 capsules), around midday (2 capsules), in the afternoon (2 capsules) and before bedtime (2 capsules) at possibly similar (approx. 4 hours) intervals. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- written informed consent from all participants before the study
- a current medical clearance to practice sports,
- training experience: at least 1 year strength training programs that include lower limbs,
- minimum of 3 workout sessions (strength/resistance training) a week,
- protein intake in customary diet and during the study protocol > 1.6g / kg of body mass per day,
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 supplementation in a blinded capsule form. | Dietary supplement | HMB supplementation |
| Placebo treatmentGroup taking oral supplementation with placebo (corn starch) in a blinded capsule form. | Dietary supplement | Placebo treatment |
Primary outcome
Changes in the maximum voluntary isometric contraction (MVIC) after supplementation and exercises-induced muscle damage
Time frame: Baseline, 24 hours and 48 hours after the end of exercises-induced muscle damage
Maximum voluntary isometric contraction (MVIC) torque (Nm)
5 secondary outcomes
Change in the histological sarcomere integrity (after biopsy of the vastus lateralis muscle samples) after supplementation and exercises-induced muscle damage
Time frame: Baseline, 24 hours and 48 hours after the end of exercises-induced muscle damage
Change in the molecular potential (after biopsy of the vastus lateralis muscle samples) after supplementation and exercises-induced muscle damage
Time frame: Baseline, 24 hours and 48 hours after the end of exercises-induced muscle damage
Change in the muscle cholesterol and mevalonate content (in the vastus lateralis muscle samples) after supplementation and exercises-induced muscle damage
Time frame: Baseline, 24 hours and 48 hours after the end of exercises-induced muscle damage
Changes in creatine kinase (CK) and lactate dehydrogenase (LDH) activity (IU) in blood after supplementation and exercises-induced muscle damage
Time frame: Baseline, 24 hours and 48 hours after the end of exercises-induced muscle damage
Change in the strength performance results (at 80% of the individual's 1RM) in three resistance exercises (squats, the leg press, and leg extension) before and after supplementation and exercises-induced muscle damage
Time frame: Baseline and 48 hours after the end of exercises-induced muscle damage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Guilherme G Artioli, Prof., PhD study chair
Applied Physiology & Nutrition Research Group, University of Sao Paulo. Sao Paulo, SP. Brazil.
Krzysztof Durkalec-Michalski, Dr hab., PhD principal investigator
Department of Sports Dietetics, Poznan University of Physical Education, Poznań, Poland
1 site in 1 country: 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 1 site in Brazil.
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 6 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: status not confirmed, as of the sponsor's last update on 23 Apr 2024. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guilherme G Artioli, Prof., PhD (+55 11 3091-8783, artioli@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the maximum voluntary isometric contraction (MVIC) after supplementation and exercises-induced muscle damage (time frame: Baseline, 24 hours and 48 hours after the end of exercises-induced muscle damage). 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 Apr 2024.