Assessing the Impact of High Theacrine Doses on Hemodynamic Measures

January 26, 2026 updated by: Titch Madzima

Exploring the Power of Theacrine: Assessing the Impact of High Theacrine Doses on Hemodynamic Measures, Cognitive Measures, and Physiological Stress

This project measured physiological and cognitive variables to determine the effectiveness of Theacrine (TCR) as a stimulant at doses greater than those previously tested. The study will be the first TCR study to use doses relative to body weight and will investigate impacts on regular caffeine consumers. A secondary aim of the study is to determine the impact of acute TCR supplementation on salivary cortisol and sAA, two physiological measures of stress and sympathetic nervous system activation. The findings of the study will provide new insight into the effects of higher TCR dosages, contributing to the analysis of TCR as a caffeine alternative for individuals with hypertension, tachycardia, or healthy caffeine consumers wanting to avoid a stimulant with adverse or habitual effects

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.

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

  • United States
    • North Carolina
      • Elon, North Carolina, United States, 27244
        • Department of Exercise Science, Koury Athletics Center at Elon 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:

- habitual caffeine consumer (≥2 days/week)

Exclusion Criteria:

  • existing heart disease or conditions (cardiovascular and/or heart disease, stroke, diabetes hypertension, tachycardia)
  • a smoker
  • allergy to caffeine or Theacrine
  • caffeine sensitivity (negative symptoms such as jitters after consuming low doses)
  • pregnant
  • on heart or blood pressure medication

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: Randomized
  • Interventional Model: Crossover 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.
Placebo Comparator: Placebo
6 mg/kg Maltodextrin Placebo
Dietary supplement: Maltodextrin (Placebo)
6 mg/kg Maltodextrin Placebo
Experimental: Low dose
3mg/kg Theacrine
Dietary supplement: Low dose theacrine
3mg/kg theacrine
Experimental: Medium dose
6mg/kg Theacrine
Dietary supplement: Medium dose theacrine
6mg/kg theacrine
Experimental: High dose
9mg/kg Theacrine
Dietary supplement: High dose theacrine
9mg/kg theacrine

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
Change in systolic blood and diastolic blood pressure post consumption of theacrine
Time Frame: Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine
mmHg change in blood pressure measures
Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine
Change in heart rate post consumption of theacrine
Time Frame: Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine
beats per minute change in heart rate measure
Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine
Changes in executive function as a measure of cognitive performance using the Trail Making Test
Time Frame: Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine
Time to completion of the Trail Making Test as a measure of executive function
Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine
Changes in attention as a measure of cognitive performance using the Flanker Inhibitory Control and Attention task
Time Frame: Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine
Accuracy of congruent and incongruent trials as measures of attention
Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine
Changes in focus as a measure of cognitive performance using the Flanker Inhibitory Control and Attention task
Time Frame: Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine
Reaction time were recorded as measures of focus
Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in salivary cortisol and alpha-amylase post consumption of theacrine
Time Frame: Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine
µg/dL change in cortisol and alpha-amylase levels from baseline as non-invasive measures of physiological stress
Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine

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.
Titch Madzima

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Takudzwa A Madzima, PhD, Elon 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.
August 9, 2023

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.
September 27, 2024

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.
November 1, 2024

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).
January 18, 2026

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.
January 26, 2026

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.
January 29, 2026

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.
January 29, 2026

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.
January 26, 2026

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.
January 1, 2026

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.
  • 2791

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all individual deidentified participant data that underlie results in a publication

IPD Sharing Time Frame

IPD data sharing will be available starting 6 months after publication

IPD Sharing Access Criteria

The data generated and analyzed during this study will be available starting 6 months after publication upon request from the principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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