The Impact of Exercise / Stress Stimuli on HMB Supplementation Efficacy
NCT ID: NCT05444959
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
130 participants
INTERVENTIONAL
2021-09-10
2025-07-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HMB supplementation
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).
HMB supplementation
Group taking oral HMB free acid supplementation in a blinded liquid form.
Placebo treatment
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).
Placebo treatment
Group taking oral supplementation with placebo (in a blinded liquid form).
Interventions
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HMB supplementation
Group taking oral HMB free acid supplementation in a blinded liquid form.
Placebo treatment
Group taking oral supplementation with placebo (in a blinded liquid form).
Eligibility Criteria
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Inclusion Criteria
* 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,
Exclusion Criteria
* 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,
* 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
20 Years
45 Years
MALE
Yes
Sponsors
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National Science Centre, Poland
OTHER_GOV
Faculty of Physical Education and Sport at Charles University, Czech Republic
UNKNOWN
Poznan University of Life Sciences, Poland
UNKNOWN
Poznan University of Medical Sciences
OTHER
Poznan University of Physical Education
OTHER
Responsible Party
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Krzysztof Durkalec-Michalski
Prof Dr hab., PhD
Principal Investigators
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Krzysztof Durkalec-Michalski, Prof., PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Sports Dietetics, Poznan University of Physical Education
Locations
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Department of Physiology and Biochemisty at the Faculty of Physical Education and Sport (Charles University, Prague, Czech Republic)
Prague, Prague 6, Czechia
Department of Sports Dietetics, Poznan University of Physical Education
Poznan, Wielkopolska, Poland
Countries
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Other Identifiers
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ZDS2022_0001
Identifier Type: -
Identifier Source: org_study_id
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