AthletesNCT05883046
The Acute Effects of Combined Caffeine and Sodium Bicarbonate Consumption on Isometric Mid-thigh Pull
A study testing Performance-Enhancing Substances in people with Athletes, run by Bozok University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects of isolated and combined caffeine and sodium bicarbonate consumption on acute isometric mid-thigh pull (IMTP) strength, and verify whether they are cumulative, neutral or subtractive. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletes
- What is being tested?
- Performance-Enhancing Substances
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Mar 2022to 12 Mar 2022
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being physically active and healthy
- Did not use ergogenic supplements in the last 3 months
- Did not consume high doses of caffeine (≤120-170 mg/d) were included in this study
Who cannot join
- Actively using supplements
- Did not perform maximal effort during performance tests
- Not using the supplements in the correct dose or vomiting after use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Sport Sciences Eskisehir Technical University
Eskişehir, Tepebasi, 26555
About this study
Official title: The Acute Effects of Pre-Exercise Isolated and Combined Caffeine and Sodium Bicarbonate Consumption on Isometric Mid-thigh Pull Performance: A Placebo-Controlled Study
The aim of this study was to investigate the effects of isolated and combined caffeine and sodium bicarbonate consumption on acute isometric mid-thigh pull (IMTP) strength, and verify whether they are cumulative, neutral or subtractive.
Read the detailed description
Method: Nineteen Sport Sciences Faculty students (Age 23.6±1.6 years, height 171±9.4 cm, weight 64.3±9.6 kg, fat percentage 20.5±7.3 %, BMI 21.7±2.4 kg/m2) participated and completed the intervention. This study was designed as crossover, double-blind and placebo-controlled. Subjects participated under 5 crossover conditions: control (without supplement) (Con), placebo (Pla), caffeine (Caf), sodium bicarbonate (NaHCO3) and caffeine+sodium bicarbonate (Caf+NaHCO3). For Caf conditions, participants consumed 6 mg/kg of caffeine, obtained from dosing the content of 200 mg capsules. As for NaHCO3 conditions, participants consumed 0.3 g/kg of sodium bicarbonate dissolved in water. For the combined condition, (Caf+NaHCO3), intake was set at 6 mg of caffeine and 0.3 g of sodium bicarbonate per kilogram of body weight. All supplements were consumed 60 min before the tests. Two submaximal trials of IMTP were performed at increasing intensities for 5 seconds (approximately %40-60 and %60-80 of their individually perceived 1RM, respectively, with 60-second rest intervals).
- Conditions
- Athletes
- Being tested
- Performance-Enhancing Substances, Placebo, Baseline (Control)
- Keywords
- Caffeine, Sodium Bicarbonate, Isometric Contraction, Performance-Enhancing Substances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance-Enhancing SubstancesOther
All supplements were consumed 60 min before the isometric mid-thigh pull tests, to reach peak blood concentrations at evaluation time. Immediately after consumption, both Control and intervention participants rested in a quiet laboratory environment (Eskişehir Technical University, Laboratory of Human Athletic Performance), until the strength tests. Participants were previously informed verbally and in writing that they should abstain from caffeine consumption (any caffeine-containing beverages and foods, such as coffee or tea, energy drinks, cocoa and cocoa-containing foods, chocolate and chocolate-containing foods or caffeine-containing drugs) for at least 24 hours before
PlaceboOther
20gr of maltodextrin (European origin, Alfasol®, Kimbiotek, Turkey)
Baseline (Control)Other
No supplement conditions
| Study group | Role | What they receive |
|---|---|---|
| Baseline | Other | The control measurement was made as a baseline measurement without supplementation Receives: Other: Baseline (Control) |
| Placebo | Placebo comparator | During Placebo conditions, participants consumed 20gr of maltodextrin (European origin, Alfasol®, Kimbiotek, Turkey). Receives: Other: Placebo |
| Caffeine | Experimental | For Caffeine conditions, participants consumed 6 mg/kg of caffeine, obtained from dosing the content of 200 mg capsules (Nature's Supreme® Caffeine) Receives: Other: Performance-Enhancing Substances |
| NaHCO3 | Experimental | As for NaHCO3 conditions, participants consumed 0.3 g/kg of sodium bicarbonate (Alfasol®, Kimbiotek, Turkey) dissolved in water Receives: Other: Performance-Enhancing Substances |
| Combined | Experimental | For the combined condition, (Caf+NaHCO3), 6 mg/kg of caffeine and 0.3 g/kg of sodium bicarbonate per kilogram of body weight of participants were consumed, after being dissolved together in water Receives: Other: Performance-Enhancing Substances |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric Mid-Thigh Pull (IMTP)
to investigate the effects of isolated and combined caffeine and sodium bicarbonate consumption on acute isometric mid-thigh pull (IMTP) strength, and verify whether they are cumulative, neutral or subtractive
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start7 Mar 2022
- Primary completion8 Mar 2022
- Study completion12 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthletesStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- subjects participated under 5 crossover conditions: control (without supplement) (Con), placebo (maltodextrin) (Pla), caffeine (Caf), sodium bicarbonate (NaHCO3) and caffeine+sodium bicarbonate (Caf+NaHCO3). The control measurement was made as a baseline measurement without supplementation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izzet Kirkaya, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883046
- Sponsor's protocol ID
- BozokU-SBF-IK-01
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data presented in this study are available on website https://osf.io/r6uz2/ with Identifier: 10.17605/OSF.IO/R6UZ2
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Pre-Exercise Isolated and Combined Caffeine and Sodium Bicarbonate Consumption on Isometric Mid-thigh Pull Performance: A Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT05883046
- Acronym / sponsor ID
- BozokU-SBF-IK-01
- Conditions
- Athletes
- Keywords
- Caffeine, Sodium Bicarbonate, Isometric Contraction, Performance-Enhancing Substances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 12 Mar 2022 (actual)
- First posted
- 31 May 2023 (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 aim of this study was to investigate the effects of isolated and combined caffeine and sodium bicarbonate consumption on acute isometric mid-thigh pull (IMTP) strength, and verify whether they are cumulative, neutral or subtractive.
Detailed description
Method: Nineteen Sport Sciences Faculty students (Age 23.6±1.6 years, height 171±9.4 cm, weight 64.3±9.6 kg, fat percentage 20.5±7.3 %, BMI 21.7±2.4 kg/m2) participated and completed the intervention. This study was designed as crossover, double-blind and placebo-controlled. Subjects participated under 5 crossover conditions: control (without supplement) (Con), placebo (Pla), caffeine (Caf), sodium bicarbonate (NaHCO3) and caffeine+sodium bicarbonate (Caf+NaHCO3). For Caf conditions, participants consumed 6 mg/kg of caffeine, obtained from dosing the content of 200 mg capsules. As for NaHCO3 conditions, participants consumed 0.3 g/kg of sodium bicarbonate dissolved in water. For the combined condition, (Caf+NaHCO3), intake was set at 6 mg of caffeine and 0.3 g of sodium bicarbonate per kilogram of body weight. All supplements were consumed 60 min before the tests. Two submaximal trials of IMTP were performed at increasing intensities for 5 seconds (approximately %40-60 and %60-80 of their individually perceived 1RM, respectively, with 60-second rest intervals).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- subjects participated under 5 crossover conditions: control (without supplement) (Con), placebo (maltodextrin) (Pla), caffeine (Caf), sodium bicarbonate (NaHCO3) and caffeine+sodium bicarbonate (Caf+NaHCO3). The control measurement was made as a baseline measurement without supplementation.
| Arm | Type | Receives |
|---|---|---|
| Baseline | Other | Other: Baseline (Control)The control measurement was made as a baseline measurement without supplementation |
| Placebo | Placebo comparator | Other: PlaceboDuring Placebo conditions, participants consumed 20gr of maltodextrin (European origin, Alfasol®, Kimbiotek, Turkey). |
| Caffeine | Experimental | Other: Performance-Enhancing SubstancesFor Caffeine conditions, participants consumed 6 mg/kg of caffeine, obtained from dosing the content of 200 mg capsules (Nature's Supreme® Caffeine) |
| NaHCO3 | Experimental | Other: Performance-Enhancing SubstancesAs for NaHCO3 conditions, participants consumed 0.3 g/kg of sodium bicarbonate (Alfasol®, Kimbiotek, Turkey) dissolved in water |
| Combined | Experimental | Other: Performance-Enhancing SubstancesFor the combined condition, (Caf+NaHCO3), 6 mg/kg of caffeine and 0.3 g/kg of sodium bicarbonate per kilogram of body weight of participants were consumed, after being dissolved together in water |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being physically active and healthy
- Did not use ergogenic supplements in the last 3 months
- Did not consume high doses of caffeine (≤120-170 mg/d) were included in this study
Key exclusion criteria (3 listed)
- Actively using supplements
- Did not perform maximal effort during performance tests
- Not using the supplements in the correct dose or vomiting after use
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 |
|---|---|---|
| Performance-Enhancing SubstancesAll supplements were consumed 60 min before the isometric mid-thigh pull tests, to reach peak blood concentrations at evaluation time. Immediately after consumption, both Control and intervention participants rested in a quiet laboratory environment (Eskişehir Technical University, Laboratory of Human Athletic Performance), until the strength tests. Participants were previously informed verbally and in writing that they should abstain from caffeine consumption (any caffeine-containing beverages and foods, such as coffee or tea, energy drinks, cocoa and cocoa-containing foods, chocolate and chocolate-containing foods or caffeine-containing drugs) for at least 24 hours before | Other | Caffeine, Combined, NaHCO3 |
| Placebo20gr of maltodextrin (European origin, Alfasol®, Kimbiotek, Turkey) | Other | Placebo |
| Baseline (Control)No supplement conditions | Other | Baseline |
Primary outcome
Isometric Mid-Thigh Pull (IMTP)
Time frame: immediately after the intervention
to investigate the effects of isolated and combined caffeine and sodium bicarbonate consumption on acute isometric mid-thigh pull (IMTP) strength, and verify whether they are cumulative, neutral or subtractive
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 31 May 2023.
- Individual participant dataSharing planned: Yes. The data presented in this study are available on website https://osf.io/r6uz2/ with Identifier: 10.17605/OSF.IO/R6UZ2
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Performance-Enhancing Substances in people with Athletes, run by Bozok University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 31 May 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 Turkey (Türkiye). 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?
Isometric Mid-Thigh Pull (IMTP) (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2023.