The Impact of Exercise / Stress Stimuli on HMB Supplementation Efficacy

NCT05444959 | Completed Phase 2

• 1 other identifier: ZDS2022_0001
• Study Type: interventional
• Target: 130
• Locations: 2 countries
• Sites: 2

Brief 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 capacity.

Conditions

Supplementation; Sport; Sports Nutrition; Sports Dietetics; Protein Kinases; Aerobic Capacity; Fat Free Mass

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  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.

  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

  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

  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

  Day 0 [Baseline (before treatment)] and after 21 days of each two supplementation periods

Study Arms (2)

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).

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).

Dietary Supplement: Placebo treatment

Interventions

HMB supplementation DIETARY_SUPPLEMENT

Group taking oral HMB free acid supplementation in a blinded liquid form.

HMB supplementation

Placebo treatment DIETARY_SUPPLEMENT

Group taking oral supplementation with placebo (in a blinded liquid form).

Placebo treatment

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Physical Education: lead
• National Science Centre, Poland: collaborator
• Faculty of Physical Education and Sport at Charles University, Czech Republic: collaborator
• Poznan University of Life Sciences, Poland: collaborator
• Poznan University of Medical Sciences: collaborator

Study Sites (2)

Department of Physiology and Biochemisty at the Faculty of Physical Education and Sport (Charles University, Prague, Czech Republic)

Prague, Prague 6, 162 52, Czechia

Location

Department of Sports Dietetics, Poznan University of Physical Education

Poznan, Wielkopolska, 61-871, Poland

Location

Study Officials

• Krzysztof Durkalec-Michalski, Prof., PhD

  Department of Sports Dietetics, Poznan University of Physical Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr hab., PhD

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: July 6, 2022
• Study Start: September 10, 2021
• Primary Completion: December 20, 2024
• Study Completion: July 1, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

CZ (1); PL (1)