Hemodynamic MeasureNCT07376564
Assessing the Impact of High Theacrine Doses on Hemodynamic Measures
A study testing Low dose theacrine, Medium dose theacrine and High dose theacrine in people with Hemodynamic Measure and Cognitive Performance in Healthy Volunteers, run by Titch Madzima at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Measure, Cognitive Performance in Healthy Volunteers
- What is being tested?
- Low dose theacrine, Medium dose theacrine and High dose theacrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2023to 1 Nov 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- habitual caffeine consumer (≥2 days/week)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Exercise Science, Koury Athletics Center at Elon University
Elon, North Carolina, 27244
About this study
Official title: 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
- Being tested
- Maltodextrin (Placebo), Low dose theacrine, Medium dose theacrine, High dose theacrine
- Keywords
- Theacrine, Hemodynamic measures, Cognitive Performance, Cortisol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maltodextrin (Placebo)Dietary supplement
6 mg/kg Maltodextrin Placebo
Low dose theacrineDietary supplement
3mg/kg theacrine
Medium dose theacrineDietary supplement
6mg/kg theacrine
High dose theacrineDietary supplement
9mg/kg theacrine
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 6 mg/kg Maltodextrin Placebo Receives: Dietary Supplement: Maltodextrin (Placebo) |
| Low dose | Experimental | 3mg/kg Theacrine Receives: Dietary Supplement: Low dose theacrine |
| Medium dose | Experimental | 6mg/kg Theacrine Receives: Dietary Supplement: Medium dose theacrine |
| High dose | Experimental | 9mg/kg Theacrine Receives: Dietary Supplement: High dose theacrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood and diastolic blood pressure post consumption of theacrine
mmHg change in blood pressure measures
Measured: Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine
Change in heart rate post consumption of theacrine
beats per minute change in heart rate measure
Measured: 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 to completion of the Trail Making Test as a measure of executive function
Measured: 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
Accuracy of congruent and incongruent trials as measures of attention
Measured: 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
Reaction time were recorded as measures of focus
Measured: Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine
Secondary outcomes (1)
Change in salivary cortisol and alpha-amylase post consumption of theacrine
µg/dL change in cortisol and alpha-amylase levels from baseline as non-invasive measures of physiological stress
Measured: Pre-consumption, then 60, 90, 120, 150, 180 minutes post-consumption of theacrine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start9 Aug 2023
- Primary completion27 Sep 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic MeasureStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Titch Madzima
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Titch Madzima, Elon University
- Investigators
- Takudzwa A Madzima, PhD, Principal investigator, Elon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376564
- Sponsor's protocol ID
- 2791
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual deidentified participant data that underlie results in a publication
Publications
Stoke C, Chandler M, Madzima T. Assessing the impact of high theacrine doses on hemodynamic measures, cognitive performance, and physiological stress. Appl Physiol Nutr Metab. 2026 Jan 1;51:1-13. doi: 10.1139/apnm-2025-0380.
PubMed 41950524
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Power of Theacrine: Assessing the Impact of High Theacrine Doses on Hemodynamic Measures, Cognitive Measures, and Physiological Stress
- ClinicalTrials.gov ID
- NCT07376564
- Acronym / sponsor ID
- 2791
- Keywords
- Theacrine, Hemodynamic measures, Cognitive Performance, Cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Titch MadzimaUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 29 Jan 2026 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrin (Placebo)6 mg/kg Maltodextrin Placebo |
| Low dose | Experimental | Dietary Supplement: Low dose theacrine3mg/kg Theacrine |
| Medium dose | Experimental | Dietary Supplement: Medium dose theacrine6mg/kg Theacrine |
| High dose | Experimental | Dietary Supplement: High dose theacrine9mg/kg Theacrine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- habitual caffeine consumer (≥2 days/week)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Maltodextrin (Placebo)6 mg/kg Maltodextrin Placebo | Dietary supplement | Placebo |
| Low dose theacrine3mg/kg theacrine | Dietary supplement | Low dose |
| Medium dose theacrine6mg/kg theacrine | Dietary supplement | Medium dose |
| High dose theacrine9mg/kg theacrine | Dietary supplement | High dose |
Primary outcome
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
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
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
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
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
1 secondary outcome
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
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 29 Jan 2026.
- Derived from this study: PubMed 41950524Stoke C, Chandler M, Madzima T. Assessing the impact of high theacrine doses on hemodynamic measures, cognitive performance, and physiological stress. Appl Physiol Nutr Metab. 2026 Jan 1;51:1-13. doi: 10.1139/apnm-2025-0380.
- Individual participant dataSharing planned: Yes. all individual deidentified participant data that underlie results in a publication
Related trials for Hemodynamic Measure
Not yet recruiting
Wearable Ultrasound Patch in Parturients
Pregnancy - Labor Monitoring, Labor and Childbirth
Not yet recruitingObservational study
UltraTrac Clinical Pilot Study
Hemodynamic Monitoring
RecruitingObservational study
Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction
RecruitingObservational study
Urine Output Response to Fluid and Diuretic Therapy in Cardiac ICU Patients Monitored With FIZE kUO®
AKI - Acute Kidney Injury, Cardiac Surgery
RecruitingObservational study
Evaluation of Feasibility of Ultrasonography Guided Pulmonary Artery Catheterization in Pulmonary Hypertension Diagnosis
Pulmonary Hypertension
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.
Takudzwa A Madzima, PhD principal investigator
Elon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose theacrine, Medium dose theacrine and High dose theacrine in people with Hemodynamic Measure and Cognitive Performance in Healthy Volunteers, run by Titch Madzima at 1 site in United States.
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 1 inclusion and 6 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 29 Jan 2026. 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 United States. 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?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07376564, which also lists 1 linked publication.
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 29 Jan 2026.