Dose-response of paraxanthine on brain function
| ISRCTN | ISRCTN68592648 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68592648 |
| Secondary identifying numbers | 0454D |
- Submission date
- 23/09/2021
- Registration date
- 24/09/2021
- Last edited
- 05/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study arms
Paraxanthine (PX) is a natural dietary component that can be found in different parts of Theobroma cacao (cocoa tree) fruits, in Coffea arabica (coffee plant), in Sinomenium actum (a traditional Chinese herbal medicine), and in citrus flowers. PX is the major metabolite (breakdown product) of caffeine in humans and is less toxic than caffeine. One-time ingestion of 200 mg PX has been shown to improve cognition, short-term memory and helps to sustain attention. However, the minimal effective and optimal dose of acute paraxanthine ingestion, and if continued daily ingestion of PX increases or decreases effectiveness, is currently unknown. The aim of this study is to measure the dose-response of paraxanthine on brain function.
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 (dummy) 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?
The potential benefit of participating is an increase in executive functioning. The ingestion of a maximum of 200 mg of paraxanthine would be less than that 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 2019 to October 2021
Who is funding the study?
Ingenious Ingredients L.P. (USA)
Who is the main contact?
Richard B. Kreider
rbkreider@tamu.edu
Contact information
Scientific
Texas A&M University
675 Kimbrough Blvd.
Building #1542
College Station
77843-4253
United States of America
 ORCID ID |
0000-0002-3906-1658 |
|---|---|
| Phone | +1 (0)979 458 1498 |
| rbkreider@tamu.edu |
Study information
| Study design | Interventional double-blinded randomized crossover controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | A dose-ranging study of paraxanthine ingestion on cognition, executive function, and psychomotor vigilance |
| Study acronym | PXDR |
| Study objectives | One-time ingestion of 200 mg paraxanthine has been shown to improve cognition, short-term memory and helps to sustain attention. However, the minimal effective and optimal dose of acute paraxanthine ingestion, and if continued daily ingestion of paraxanthine will result in increased or diminished efficacy is currently unknown. |
| Ethics approval(s) | Approved 28/10/2019, Texas A&M University Institutional Review Board (517 Blocker Building, 155 Ireland Street, Texas A&M University, College Station, TX 778431, USA; +1 (0)979 458 4067; irb@tamu.edu), ref: IRB2019-0807F |
| Health condition(s) or problem(s) studied | Executive functioning in healthy individuals |
| Intervention | Subjects consume capsules containing 50, 100 or 200 mg of paraxanthine (ENFINITY™, Ingenious Ingredients L.P., Lewisville, TX, USA) or capsules containing wheat flour placebo (placebo) once they have completed baseline testing. One capsule of the PLA or PX is taken with 8 ounces of water daily for 7 days. A computer-generated randomization to treatment is used. Once subjects are randomized to start, they follow the counterbalance progression. |
| Intervention type | Supplement |
| Primary outcome measure | 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: 1. Berg-Wisconsin Card Sorting Task test (BCST) at baseline, 1, 2, 3, 4, 5 and 6 hours after initial ingestion and 1 hour after daily ingestion for 7 days 2. The Go/No-Go test (GNG) at baseline, 1, 2, 3, 4, 5 and 6 hours after initial ingestion and 1 hour after daily ingestion for 7 days 3. Sternberg Task Test (STT) at baseline, 1, 2, 3, 4, 5 and 6 hours after initial ingestion and 1 hour after daily ingestion for 7 days 4. Psychomotor Vigilance Task Test (PVTT) at baseline, 1, 2, 3, 4, 5 and 6 hours after initial ingestion and 1 hour after daily ingestion for 7 days |
| Secondary outcome measures | Safety measured using: 1. Side Effect Questionnaire: participants will rank the frequency of dizziness, headache, tachycardia, heart skipping/palpitations, shortness of breath, nervousness, blurred vision, and any other adverse effects) using a scale where 0 = none; 1 = 1-2/week, 2 = 3-4/week, 3 = 5-6/week, 4 = 7-8/week, and 5 = ≥9/week. They will also rate the severity of these side effects where 0 = none, 1 = minimal, 2 = slight, 3 = moderate, 4 = severe, and 5 = very severe at baseline, 6 hours after the first ingestion, and 1 hour after daily ingestion on day 7 2. Changes in blood clinical chemistries at baseline, 6 hours after the first ingestion, and 1 hour after daily ingestion on day 7 |
| Overall study start date | 01/04/2019 |
| Completion date | 06/10/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 15 |
| Total final enrolment | 15 |
| Key inclusion criteria | 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 |
| Date of first enrolment | 01/11/2019 |
| Date of final enrolment | 21/07/2020 |
Locations
Countries of recruitment
- United States of America
Study participating centre
College Station
77843-4253
United States of America
Sponsor information
Industry
2560 King Arthur Blvd. Suite 124-74
Lewisville
75056
United States of America
| Phone | +1 (0)704 619 1692 |
|---|---|
| info@ingeniousingredients.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a peer-reviewed scientific journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. Please contact Prof. Dr Richard Kreider (rbkreider@tamu.edu) with any requests. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/12/2021 | 05/01/2022 | Yes | No |
Editorial Notes
05/01/2022: Publication reference added.
23/09/2021: Trial's existence confirmed by Texas A&M University Institutional Review Board.
