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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • 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

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
Intervention / Treatment
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

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

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

Titch Madzima

Investigators

  • 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)

August 9, 2023

Primary Completion (Actual)

September 27, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Cognitive Performance in Healthy Volunteers

Clinical Trials on Maltodextrin (Placebo)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe