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Completed

NCT Number: NCT07376564

Assessing the Impact of High Theacrine Doses on Hemodynamic Measures

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

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Key information

Conditions

Hemodynamic Measure Cognitive Performance in Healthy Volunteers

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Exercise Science, Koury Athletics Center at Elon University

Elon, North Carolina, 27244, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maltodextrin (Placebo)

Dietary Supplement

6 mg/kg Maltodextrin Placebo

Low dose theacrine

Dietary Supplement

3mg/kg theacrine

Medium dose theacrine

Dietary Supplement

6mg/kg theacrine

High dose theacrine

Dietary Supplement

9mg/kg theacrine

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Titch Madzima

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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