The Impact of Exercise / Stress Stimuli on HMB Supplementation Efficacy

  • End date
    Jul 1, 2024
  • participants needed
  • sponsor
    Poznan University of Physical Education
Updated on 4 October 2022
Accepts healthy volunteers


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.


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.

Condition Supplementation, Sport, Sports Nutrition, Sports Dietetics, Protein Kinases, Aerobic Capacity, Fat Free Mass
Treatment Placebo Treatment, HMB supplementation
Clinical Study IdentifierNCT05444959
SponsorPoznan University of Physical Education
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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 certain features of the body malnutrition (BMI < 18.5), low lean body mass (FFMI < 17.4) and lack of regular physical activity that never were trained in competitive sports

Exclusion Criteria

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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note