The Acute Effects of Combined Caffeine and Sodium Bicarbonate Consumption on Isometric Mid-thigh Pull

May 28, 2023 updated by: Izzet Kirkaya, Bozok University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Tepebasi
      • Eskişehir, Tepebasi, Turkey, 26555
        • Faculty of Sport Sciences Eskisehir Technical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Actively using supplements
  • Did not perform maximal effort during performance tests
  • Not using the supplements in the correct dose or vomiting after use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Baseline
The control measurement was made as a baseline measurement without supplementation
Other: Baseline (Control)
No supplement conditions
Placebo Comparator: Placebo
During Placebo conditions, participants consumed 20gr of maltodextrin (European origin, Alfasol®, Kimbiotek, Turkey).
Other: Placebo
20gr of maltodextrin (European origin, Alfasol®, Kimbiotek, Turkey)
Experimental: Caffeine
For Caffeine conditions, participants consumed 6 mg/kg of caffeine, obtained from dosing the content of 200 mg capsules (Nature's Supreme® Caffeine)
Other: Performance-Enhancing Substances
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
Experimental: NaHCO3
As for NaHCO3 conditions, participants consumed 0.3 g/kg of sodium bicarbonate (Alfasol®, Kimbiotek, Turkey) dissolved in water
Other: Performance-Enhancing Substances
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
Experimental: Combined
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
Other: Performance-Enhancing Substances
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bozok University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BozokU-SBF-IK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data presented in this study are available on website https://osf.io/r6uz2/ with Identifier: 10.17605/OSF.IO/R6UZ2

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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