NCT05230303

Brief Summary

The purpose of this study is to verify the effect of acute caffeine intake on resistance training volume and blood antioxidant status, in a randomised, double-blind, placebo-controlled crossover trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

January 14, 2022

Last Update Submit

March 8, 2023

Conditions

Caffeine

Keywords

sports performance, resistance training, nutrition, athlete

Outcome Measures

Primary Outcomes (4)

  • Change the levels of oxidative stress markers

    Serum will be obtained for TOS/TOC (total oxidative stress), MDA (malondialdehyde), oncentration of TAS (total antioxidant status), activity of superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPx); concentartion of GSH (reduced glutathione) and UA (uric acid)

    Day 1, Day 2

  • Changes in markers of muscle damage

    Serum will be obtained for activity of creatine kinase (CK) and lactate dehydrogenase (LDH), concentration of myoglobin (Mb)

    Day 1, Day 2

  • Changes in Inflammation markers

    Serum will be obtained for level of interleukin 6, TNF alfa (tumor matrix factor), CRP (C-reactive protein)

    Day 1, Day 2

  • Changes in markers of liver function

    Serum will be obtained for activity of ASPAT (aspartate aminotransferase), ALAT (alanine aminotransferase) and gamma glutamyltransferase (GGT)

    Day 1, Day 2

Secondary Outcomes (4)

  • Changes in resistance training volume

    During caffeine and placebo treatment

  • Changes in rate of perceived exertion after resistance training

    Immediately after exercise protocol during caffeine and placebo treatment

  • Changes in heart rate during resistance training

    During caffeine and placebo treatment

  • Changes in muscle soreness

    prior to exercise, and 24, 48, 72, 96 and 120 hours post exercise.

Study Arms (2)

Caffeine supplementation

EXPERIMENTAL

Group taking 3 mg/kg of caffeine

Dietary Supplement: Caffeine supplementation

Placebo treatment

PLACEBO COMPARATOR

Group taking placebo

Dietary Supplement: Placebo treatment

Interventions

Caffeine supplementationDIETARY_SUPPLEMENT

Two identical experimental sessions with a one-week interval between sessions (to allow complete recovery and ensure substance wash-out) will be taken. During the experimental sessions, participants will ingest caffeine in dose of 3 mg/kg of body mass. Caffeine will be provided in capsules containing the individual amount of caffeine and will be administered orally 60 min before the onset of the exercise protocol.

Caffeine supplementation
Placebo treatmentDIETARY_SUPPLEMENT

The experimental procedure for each particpant will include placebo supplementation. The manufacturer of the caffeine capsules will also prepare identical placebo capsules filled out with a microcrystalline cellulose. Placebo will be administered orally 60 min before the onset of the exercise protocol.

Placebo treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • written consent to participate,
  • medical permission by physician
  • "resistance-trained," defined as having a minimum of two years of resistance training experience
  • minimum of 2 workout sessions per week in the last 6 months

You may not qualify if:

  • neuromuscular or musculoskeletal disorders
  • current injury
  • using any medications, dietary supplements or ergogenic aids which could potentially affect the study outcomes
  • a positive smoking status
  • potential allergy to caffeine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Jerzy Kukuczka Academy of Physical Education

Katowice, 40-065, Poland

Location

Related Publications (1)

  • Filip-Stachnik A, Krzysztofik M, Del Coso J, Palka T, Sadowska-Krepa E. The Effect of Acute Caffeine Intake on Resistance Training Volume, Prooxidant-Antioxidant Balance and Muscle Damage Markers Following a Session of Full-Body Resistance Exercise in Resistance-Trained Men Habituated to Caffeine. J Sports Sci Med. 2023 Sep 1;22(3):436-446. doi: 10.52082/jssm.2023.436. eCollection 2023 Sep.

    PMID: 37711718DERIVED

Study Officials

  • Adam Zając, Profesor

    The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 14, 2022

First Posted

February 8, 2022

Study Start

January 12, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

March 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

We do not plan to share IPD.

Locations

PL(1)