CognitionPhase 1/2PXNNCT06628596
Acute Effects of Paraxanthine on Energy and Focus
A Phase 1/2 study testing Paraxanthine 200mg and 300mg in people with Cognition and Appetite, run by Iovate Health Sciences International Inc at 1 site in United States.
Trial summary
This study aims to evaluate the effects of paraxanthine (200 mg and 300 mg) on energy, focus, appetite, and cognitive performance in healthy adults. Using a double-blind, placebo-controlled, crossover design, participants will receive paraxanthine or placebo 30 minutes before a meal. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition, Appetite, Mental Energy
- What is being tested?
- Paraxanthine 200mg and 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2024to 14 Aug 2024
- Phase
- Phase 1/2
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily provide signed and dated informed consent.
- Be in good health as determined by medical history and routine blood chemistries.
- Age between 20 and 40 years (inclusive).
- Body Mass Index of 18.5-29.9 (inclusive).
- Body weight of at least 120 pounds.
- Normotensive (supine, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
- Normal supine, resting heart rate (< 90 per minute).
- Willing to duplicate their previous 24-hour diet, refrain from alcohol, caffeine, and exercise for 24 hr prior to each trial, and fast for 8 hours prior to each trial.
Who cannot join
- Current smoker or other nicotine use (i.e. vape, patch, etc.).
- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- Prior gastrointestinal bypass surgery (Lapband, etc.).
- Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU).
- Chronic inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
- History of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
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- History of cognitive disorder.
- History of psychiatric disorder.
- Known sensitivity to any ingredient in the test formulations as listed in the Certificates-of-Analysis.
- Women currently pregnant, trying to become pregnant or breastfeeding a child.
- Use of anxiety or ADHD medication.
- Caffeine intake of three or more cups of coffee or equivalent (>400 mg) per day.
- Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence.
- Clinically significant abnormal laboratory results at screening.
- Prior gastrointestinal bypass surgery (Lapband, etc.).
- Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
- Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center For Applied Health Sciences
Canfield, Ohio, 44406
About this study
Official title: Acute Effects of Paraxanthine on Energy, Focus, Appetite, and Cognition: Double-Blind, Placebo-Controlled Trial
This study aims to evaluate the effects of paraxanthine (200 mg and 300 mg) on energy, focus, appetite, and cognitive performance in healthy adults. Using a double-blind, placebo-controlled, crossover design, participants will receive paraxanthine or placebo 30 minutes before a meal. Cognition tests and visual Analogue Scale (VAS) ratings for energy, focus, productivity, satiety, and appetite will be collected at multiple time points post-consumption.
Read the detailed description
Caffeine (CAF) is one of the most consumed naturally occurring nootropic and exercise-related ergogenic aids. Paraxanthine (1,7-dimethylxanthine, PXN) is the main metabolite of CAF, accounting for 70-72% of CAF ingested, and 85% of the methylxanthine metabolic by-products. While caffeine has been extensively studied for its effects on energy, and focus in humans, the effects of paraxanthine are less understood.
It was recently reported that acute ingestion of PXN enhances various markers of focus such as memory, reaction time, and attention for up to 6-hours in healthy adults, and that acute ingestion as low as 50 mg of PXN for 7-days enhanced measures of cognition, memory, reasoning, response time, and helped sustain attention. While studies were performed in the fasted state and over 6 hours which is beyond the ~3.1h half-life of paraxanthine, the cognitive effects of paraxanthine in response to an ecologically valid meal over a 3-hour period is limited. Therefore, the purpose of this study is to assess the impact of paraxanthine on energy, focus, and cognition in younger healthy adults in the fed state.
- Conditions
- Cognition, Appetite, Mental Energy, Dietary Supplement
- Being tested
- Paraxanthine 200mg and 300mg
- Keywords
- cognition, appetite, mental energy, mental focus, dietary supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paraxanthine 200mg and 300mgDietary supplement
Also called Placebo (PLA), Paraxanthine 200mg (PXN 200), Paraxanthine 300mg (PXN 300)
Participants consumed 200 mg paraxanthine (PXN 200), 300 mg paraxanthine (PXN 300), or placebo (PLA) after an overnight fast. Supplements were ingested 30 minutes before a mixed meal in double-blind, randomized, placebo-controlled, crossover fashion.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | After qualifying for the study, subjects will be randomly assigned to receive a placebo, 200mg PXN, and 300mg PXN using a Latin Square design.
* Paraxanthine (200 mg)
* Paraxanthine (300 mg)
* Placebo (containing 300mg resistant starch) •Supplements will be provided in identical-looking capsules with label directions and Study Protocol Number. Receives: Dietary Supplement: Paraxanthine 200mg and 300mg |
| Paraxanthine 200mg | Active comparator | After qualifying for the study, subjects will be randomly assigned to receive a placebo, 200mg PXN, and 300mg PXN using a Latin Square design.
* Paraxanthine (200 mg)
* Paraxanthine (300 mg)
* Placebo (containing 300mg resistant starch) •Supplements will be provided in identical-looking capsules with label directions and Study Protocol Number. Receives: Dietary Supplement: Paraxanthine 200mg and 300mg |
| Paraxanthine 300mg | Active comparator | After qualifying for the study, subjects will be randomly assigned to receive a placebo, 200mg PXN, and 300mg PXN using a Latin Square design.
* Paraxanthine (200 mg)
* Paraxanthine (300 mg)
* Placebo (containing 300mg resistant starch) •Supplements will be provided in identical-looking capsules with label directions and Study Protocol Number. Receives: Dietary Supplement: Paraxanthine 200mg and 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy
Using 100 mm anchored visual analogue scale. Higher scores indicate an improvement.
Measured: Energy (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.
Focus
Using 100 mm anchored visual analogue scale. Higher scores indicate an improvement.
Measured: Focus (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.
N-Back Task
Two repetitions of the N-Back Task (90s in duration) to assess memory, attention and decision making
Measured: Assessed at t = - 30min (prior to study product ingestion) and at t = 0 min immediately before the standardized mealand 30-, 60-, 120-, and 180 minutes post meal ingestion.
Go/No-Go Task
Two repetitions of the Go/No-Go Task (90s in duration) to assess measures of attention, processing speed and impulse control
Measured: Assessed at t = - 30min (prior to study product ingestion) and at t = 0 min immediately before the standardized mealand 30-, 60-, 120-, and 180 minutes post meal ingestion.
Serial 7s
Two repetitions of Serial 7s (90s in duration) to assess attention, working memory, and mental arithmetic's.
Measured: Assessed at t = - 30min (prior to study product ingestion) and at t = 0 min immediately before the standardized mealand 30-, 60-, 120-, and 180 minutes post meal ingestion.
Secondary outcomes (3)
Satiety/Feelings of fullness
Using 100 mm anchored visual analogue scale. Higher scores indicate an improvement.
Measured: Satiety/Feelings of fullness (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.
Appetite
Using 100 mm anchored visual analogue scale. Higher scores indicate an improvement.
Measured: Appetite (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.
Productivity
Using 100 mm anchored visual analogue scale. Higher scores indicate an improvement.
Measured: Productivity (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start7 May 2024
- Primary completion19 Jul 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iovate Health Sciences International Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628596
- Sponsor's protocol ID
- IOV-001-032024
- Acronym
- PXN
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Case by case basis.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Paraxanthine on Energy, Focus, Appetite, and Cognition: Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06628596
- Acronym / sponsor ID
- PXN / IOV-001-032024
- Conditions
- Cognition, Appetite, Mental Energy, Dietary Supplement
- Keywords
- cognition, appetite, mental energy, mental focus, dietary supplement
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Iovate Health Sciences International IncIndustry (pharma, biotech, devices)
- Study start
- 7 May 2024 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 8 Oct 2024 (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 study aims to evaluate the effects of paraxanthine (200 mg and 300 mg) on energy, focus, appetite, and cognitive performance in healthy adults. Using a double-blind, placebo-controlled, crossover design, participants will receive paraxanthine or placebo 30 minutes before a meal. Cognition tests and visual Analogue Scale (VAS) ratings for energy, focus, productivity, satiety, and appetite will be collected at multiple time points post-consumption.
Detailed description
Caffeine (CAF) is one of the most consumed naturally occurring nootropic and exercise-related ergogenic aids. Paraxanthine (1,7-dimethylxanthine, PXN) is the main metabolite of CAF, accounting for 70-72% of CAF ingested, and 85% of the methylxanthine metabolic by-products. While caffeine has been extensively studied for its effects on energy, and focus in humans, the effects of paraxanthine are less understood.
It was recently reported that acute ingestion of PXN enhances various markers of focus such as memory, reaction time, and attention for up to 6-hours in healthy adults, and that acute ingestion as low as 50 mg of PXN for 7-days enhanced measures of cognition, memory, reasoning, response time, and helped sustain attention. While studies were performed in the fasted state and over 6 hours which is beyond the ~3.1h half-life of paraxanthine, the cognitive effects of paraxanthine in response to an ecologically valid meal over a 3-hour period is limited. Therefore, the purpose of this study is to assess the impact of paraxanthine on energy, focus, and cognition in younger healthy adults in the fed state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Paraxanthine 200mg and 300mgAfter qualifying for the study, subjects will be randomly assigned to receive a placebo, 200mg PXN, and 300mg PXN using a Latin Square design. * Paraxanthine (200 mg) * Paraxanthine (300 mg) * Placebo (containing 300mg resistant starch) •Supplements will be provided in identical-looking capsules with label directions and Study Protocol Number. |
| Paraxanthine 200mg | Active comparator | Dietary Supplement: Paraxanthine 200mg and 300mgAfter qualifying for the study, subjects will be randomly assigned to receive a placebo, 200mg PXN, and 300mg PXN using a Latin Square design. * Paraxanthine (200 mg) * Paraxanthine (300 mg) * Placebo (containing 300mg resistant starch) •Supplements will be provided in identical-looking capsules with label directions and Study Protocol Number. |
| Paraxanthine 300mg | Active comparator | Dietary Supplement: Paraxanthine 200mg and 300mgAfter qualifying for the study, subjects will be randomly assigned to receive a placebo, 200mg PXN, and 300mg PXN using a Latin Square design. * Paraxanthine (200 mg) * Paraxanthine (300 mg) * Placebo (containing 300mg resistant starch) •Supplements will be provided in identical-looking capsules with label directions and Study Protocol Number. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Voluntarily provide signed and dated informed consent.
- Be in good health as determined by medical history and routine blood chemistries.
- Age between 20 and 40 years (inclusive).
- Body Mass Index of 18.5-29.9 (inclusive).
- Body weight of at least 120 pounds.
Key exclusion criteria (17 listed)
- Current smoker or other nicotine use (i.e. vape, patch, etc.).
- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- Prior gastrointestinal bypass surgery (Lapband, etc.).
- Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU).
- Chronic inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
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 |
|---|---|---|
| Paraxanthine 200mg and 300mgAlso: Placebo (PLA), Paraxanthine 200mg (PXN 200), Paraxanthine 300mg (PXN 300)Participants consumed 200 mg paraxanthine (PXN 200), 300 mg paraxanthine (PXN 300), or placebo (PLA) after an overnight fast. Supplements were ingested 30 minutes before a mixed meal in double-blind, randomized, placebo-controlled, crossover fashion. | Dietary supplement | Paraxanthine 200mg, Paraxanthine 300mg, Placebo |
Primary outcome
Energy
Time frame: Energy (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.
Using 100 mm anchored visual analogue scale. Higher scores indicate an improvement.
Focus
Time frame: Focus (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.
Using 100 mm anchored visual analogue scale. Higher scores indicate an improvement.
N-Back Task
Time frame: Assessed at t = - 30min (prior to study product ingestion) and at t = 0 min immediately before the standardized mealand 30-, 60-, 120-, and 180 minutes post meal ingestion.
Two repetitions of the N-Back Task (90s in duration) to assess memory, attention and decision making
Go/No-Go Task
Time frame: Assessed at t = - 30min (prior to study product ingestion) and at t = 0 min immediately before the standardized mealand 30-, 60-, 120-, and 180 minutes post meal ingestion.
Two repetitions of the Go/No-Go Task (90s in duration) to assess measures of attention, processing speed and impulse control
Serial 7s
Time frame: Assessed at t = - 30min (prior to study product ingestion) and at t = 0 min immediately before the standardized mealand 30-, 60-, 120-, and 180 minutes post meal ingestion.
Two repetitions of Serial 7s (90s in duration) to assess attention, working memory, and mental arithmetic's.
3 secondary outcomes
Satiety/Feelings of fullness
Time frame: Satiety/Feelings of fullness (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.
Appetite
Time frame: Appetite (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.
Productivity
Time frame: Productivity (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.
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 8 Oct 2024.
- The Center For Applied Health Sciences WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Case by case basis.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Paraxanthine 200mg and 300mg in people with Cognition and Appetite, run by Iovate Health Sciences International Inc 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 8 inclusion and 17 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 8 Oct 2024. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Energy (time frame: Energy (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.). 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?
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 8 Oct 2024.