CaffeineNCT05230303
Caffeine Supplementation, Resistance Training and Blood Antioxidant Status
A study testing Caffeine supplementation in people with Caffeine, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Caffeine
- What is being tested?
- Caffeine supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 sitePoland
- Study dates
- 12 Jan 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Caffeine Supplementation on Resistance Training Volume and Blood Antioxidant Status in Resitance Trained Men
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.
Read the detailed description
Caffeine is one of the most commonly consumed psychoactive substances in the world. Several previous studies confirmed that caffeine improves several aspects of exercise performance, including resistance training outcomes. Interestingly, caffeine and its catabolic products, theobromine and xanthine, exhibit antioxidant and prooxidant properties. Additionally, resistance training promotes the generation of reactive oxygen species, which are important for the cellular adaptation process.
Hovewer, to the best of our knowledge, there is no information as to how caffeine combined with resistance training affects blood antioxidant status. Therefore, the aim of this study was to examine acute effects of caffeine supplementation on resistance training volume and blood antioxidant status in resistance trained men.
- Conditions
- Caffeine
- Being tested
- Caffeine supplementation, Placebo treatment
- Keywords
- sports performance, resistance training, nutrition, athlete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine supplementation | Experimental | Group taking 3 mg/kg of caffeine Receives: Dietary Supplement: Caffeine supplementation |
| Placebo treatment | Placebo comparator | Group taking placebo Receives: Dietary Supplement: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 1, Day 2
Secondary outcomes (4)
Changes in resistance training volume
Measured: During caffeine and placebo treatment
Changes in rate of perceived exertion after resistance training
Measured: Immediately after exercise protocol during caffeine and placebo treatment
Changes in heart rate during resistance training
Measured: During caffeine and placebo treatment
Changes in muscle soreness
Measured: prior to exercise, and 24, 48, 72, 96 and 120 hours post exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start12 Jan 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CaffeineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in Katowice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Filip-Stachnik, The Jerzy Kukuczka Academy of Physical Education in Katowice
- Investigators
- Adam Zając, Profesor, Study director, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230303
- Sponsor's protocol ID
- 01_2021
- Status last verified
- Mar 2023
- First submitted
- 14 Jan 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD.
Publications
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.
PubMed 37711718
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Caffeine Supplementation on Resistance Training Volume and Blood Antioxidant Status in Resitance Trained Men
- ClinicalTrials.gov ID
- NCT05230303
- Acronym / sponsor ID
- 01_2021
- Conditions
- Caffeine
- Keywords
- sports performance, resistance training, nutrition, athlete
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in KatowiceUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Caffeine is one of the most commonly consumed psychoactive substances in the world. Several previous studies confirmed that caffeine improves several aspects of exercise performance, including resistance training outcomes. Interestingly, caffeine and its catabolic products, theobromine and xanthine, exhibit antioxidant and prooxidant properties. Additionally, resistance training promotes the generation of reactive oxygen species, which are important for the cellular adaptation process.
Hovewer, to the best of our knowledge, there is no information as to how caffeine combined with resistance training affects blood antioxidant status. Therefore, the aim of this study was to examine acute effects of caffeine supplementation on resistance training volume and blood antioxidant status in resistance trained men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine supplementation | Experimental | Dietary Supplement: Caffeine supplementationGroup taking 3 mg/kg of caffeine |
| Placebo treatment | Placebo comparator | Dietary Supplement: Placebo treatmentGroup taking placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine supplementationTwo 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. | Dietary supplement | Caffeine supplementation |
| Placebo treatmentThe 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. | Dietary supplement | Placebo treatment |
Primary outcome
Change the levels of oxidative stress markers
Time frame: Day 1, Day 2
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)
Changes in markers of muscle damage
Time frame: Day 1, Day 2
Serum will be obtained for activity of creatine kinase (CK) and lactate dehydrogenase (LDH), concentration of myoglobin (Mb)
Changes in Inflammation markers
Time frame: Day 1, Day 2
Serum will be obtained for level of interleukin 6, TNF alfa (tumor matrix factor), CRP (C-reactive protein)
Changes in markers of liver function
Time frame: Day 1, Day 2
Serum will be obtained for activity of ASPAT (aspartate aminotransferase), ALAT (alanine aminotransferase) and gamma glutamyltransferase (GGT)
4 secondary outcomes
Changes in resistance training volume
Time frame: During caffeine and placebo treatment
Changes in rate of perceived exertion after resistance training
Time frame: Immediately after exercise protocol during caffeine and placebo treatment
Changes in heart rate during resistance training
Time frame: During caffeine and placebo treatment
Changes in muscle soreness
Time frame: prior to exercise, and 24, 48, 72, 96 and 120 hours post exercise.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Derived from this study: PubMed 37711718Filip-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.
- Individual participant dataSharing planned: No. We do not plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Zając, Profesor study director
The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine supplementation in people with Caffeine, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change the levels of oxidative stress markers (time frame: Day 1, Day 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05230303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.