HMB and Exercise-induced Muscle Damage

NCT04549610 | Recruiting Phase 2

• 1 other identifier: ULS2020.001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 exercise-induced muscle damage.

Conditions

Supplementation; Sport; Sports Nutrition; Muscle Damage; Recovery

Outcome Measures

Primary Outcomes (1)

• Changes in the maximum voluntary isometric contraction (MVIC) after supplementation and exercises-induced muscle damage

  Maximum voluntary isometric contraction (MVIC) torque (Nm)

  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

  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

  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

  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

  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

  Baseline and 48 hours after the end of exercises-induced muscle damage

Study Arms (2)

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.

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.

Dietary Supplement: Placebo treatment

Interventions

HMB supplementation DIETARY_SUPPLEMENT

Group taking oral HMB supplementation in a blinded capsule form.

HMB supplementation

Placebo treatment DIETARY_SUPPLEMENT

Group taking oral supplementation with placebo (corn starch) in a blinded capsule form.

Placebo treatment

Eligibility Criteria

• Age: 18 Years - 35 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,
• 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.

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 creatine, caffeine or beta-alanine, or other 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
• Escola de Educação Física e Esporte da Universidade de São Paulo (Brazil) - Parallel sponsor of the research: collaborator
• National Science Centre, Poland: collaborator

Study Sites (1)

Escola de Educação Física e Esporte da USP / School of Physical Education and Sport - USP.

São Paulo, São Paulo - SP, 05508-030, Brazil

RECRUITING

Study Officials

• Guilherme G Artioli, Prof., PhD

  Applied Physiology & Nutrition Research Group, University of Sao Paulo. Sao Paulo, SP. Brazil.

  STUDY CHAIR

• Krzysztof Durkalec-Michalski, Dr hab., PhD

  Department of Sports Dietetics, Poznan University of Physical Education, Poznań, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guilherme G Artioli, Prof., PhD

CONTACT

+55 11 3091-8783; artioli@usp.br

Krzysztof Durkalec-Michalski, Prof., PhD

CONTACT

+48 61 835 51 65; durkalec-michalski@awf.poznan.pl

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: September 8, 2020
• First Posted: September 16, 2020
• Study Start: November 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

BR (1)