Effects of HMB Supplementation on Muscle and Hormones with Exercise
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
This study is testing if taking HMB supplements can help improve muscle and hormone levels in both active people and those who are malnourished over 21 days.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Male |
| Sponsor | Poznan University of Physical Education Academic / other |
| Locations | 2 sites (Prague, Prague 6 and 1 other locations) |
| Trial ID | NCT05444959 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of β-hydroxy-β-methylbutyrate (HMB) supplementation on protein kinase activity and hormone levels over 21 days in two groups: exercise-trained individuals and those with malnutrition. Participants will receive either HMB or a placebo while following their usual exercise or lifestyle routines, with an additional functional training program introduced in the second phase. The study is designed as a double-blind, randomized, placebo-controlled trial to ensure unbiased results. The primary outcomes include changes in muscle protein synthesis, lean body mass, and aerobic capacity.
Who should consider this trial
Good fit: Ideal candidates include exercise-trained individuals engaging in regular physical activity and inactive individuals with features of malnutrition.
Not a fit: Patients with current injuries, serious diseases, or those who have recently used certain supplements or steroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance muscle growth and overall physical performance in both trained athletes and individuals with malnutrition.
How similar studies have performed: Previous studies have shown promising results with HMB supplementation in enhancing muscle mass and performance, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Prague, Prague 6 and 1 other locations
- Department of Physiology and Biochemisty at the Faculty of Physical Education and Sport (Charles University, Prague, Czech Republic) — Prague, Prague 6, Czechia (Recruiting)
- Department of Sports Dietetics, Poznan University of Physical Education — Poznań, Wielkopolska, Poland (Recruiting)
Study contacts
- Principal investigator: Krzysztof Durkalec-Michalski, Prof., PhD — Department of Sports Dietetics, Poznan University of Physical Education
- Study coordinator: Krzysztof Durkalec-Michalski, Prof., PhD
- Email: durkalec-michalski@awf.poznan.pl
- Phone: +48 61 835 51 65
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.