Effects of paraxanthine on brain function
| ISRCTN | ISRCTN66975000 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66975000 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 0453D |
| Sponsor | Ingenious Ingredients L.P. |
| Funder | Ingenious Ingredients, L.P. |
- Submission date
- 13/09/2021
- Registration date
- 15/09/2021
- Last edited
- 19/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study arms
Paraxanthine (1,7-dimethylxanthine, PX) is a natural dietary component that can be found in different parts of Theobroma cacao fruits, in Coffea arabica, in the rhizome and stem of Sinomenium actum, a traditional Chinese herbal medicine, and in the stamens of citrus flowers. PX is the major metabolite of caffeine in humans and is less toxic than caffeine. The potential beneficial effects of acute PX ingestion on executive function in healthy individuals are currently unknown. In this study, we are investigating the effects of 200mg of acute PX ingestion in comparison to placebo.
Who can participate?
Healthy males and females between the ages of 18 to 59 years
What does the study involve?
Participants will be randomly allocated to receive PX or placebo capsules, and then perform four cognitive function tests that assess a range of cognitive and executive function aspects.
What are the possible benefits and risks of participating?
Potential benefits of participating is an increase in executive functioning. The ingestion of 200 mg of paraxanthine would be less than obtained from consuming a premium cup of coffee or energy drink.
Where is the study run from?
Texas A&M University (USA)
When is the study starting and how long is it expected to run for?
April July 2019 to November 2019.
Who is funding the study?
Ingenious Ingredients L.P., Lewisville, TX (USA)
Who is the main contact?
Richard B. Kreider, PhD, FACSM, FASEP, FISSN, FACN, FNAK, rbkreider@tamu.edu
Contact information
Scientific
Texas A&M University
675 Kimbrough Blvd., Building #1542
College Station, TX
77843-4253
United States of America
 ORCID ID |
0000-0002-3906-1658 |
|---|---|
| Phone | +1 979-458-1498 |
| rbkreider@tamu.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional double-blinded randomized crossover controlled trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Effects of acute ParaXanthine ingestion on Executive Function |
| Study acronym | PXEF |
| Study objectives | Paraxanthine (1,7-dimethylxanthine, PX) increases executive functioning. |
| Ethics approval(s) | Approved 19/07/2019, Texas A&M University Institutional Review Board (517 Blocker Building, 155 Ireland Street, Texas A&M University, College Station, TX 778431, USA; +1 979-458-4067; irb@tamu.edu), ref: IRB2019-0453D |
| Health condition(s) or problem(s) studied | Improving executive functioning in healthy individuals |
| Intervention | Subjects consumed capsules containing 200 mg of paraxanthine (ENFINITY™, Ingenious Ingredients L.P., Lewisville, TX, USA) or capsules containing 200 mg of a wheat flour placebo (Placebo) once they have completed baseline testing. One capsule of the PLA or PX with 8 ounces of water. A computer generated randomization to treatment was used. Once subjects were randomized to start, they followed the counter balance progression. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
The Psychology Experiment Building Language (PEBL) software program (Version 2.1, http://pebl.sourceforge.net) was used to administer four cognitive function tests that assessed a range of cognitive and executive function aspects: |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 10/11/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 14 |
| Total final enrolment | 14 |
| Key inclusion criteria | Apparently healthy males and females between the ages of 18 to 59 were recruited to participate in the study. All subjects were healthy and free from known: 1. Cognitive deficit conditions 2. Wheat flour allergies 3. Sleep disorders 4. Cardiovascular, metabolic, or pulmonary diseases 5. History of hypertension, migraine headaches, cardiac arrhythmias, or anxiety 6. Gastrointestinal reflux disease or ulcers |
| Key exclusion criteria | Subjects who were taking prescription medications in the month prior to the initiation of the study and/or were told by a physician to abstain or restrict caffeine and/or stimulant intake were excluded from the present study. |
| Date of first enrolment | 20/07/2019 |
| Date of final enrolment | 10/11/2019 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Building #1542
College Station, Texas
77843-4253
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 09/11/2021 | 19/11/2021 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/11/2021: Publication reference added.
15/09/2021: Trial's existence confirmed by Texas A&M University.
