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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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Research has shown that acute ingestion of Paraxanthine (1,7-dimethylxanthine, PXN) can enhance various markers of focus, including memory, reaction time, and attention in healthy adults. To assess these effects, this placebo-controlled crossover trial will compare the effects of 200 and 300mg of PXN to a placebo control. Participants will abstain from caffeine for 3 days, before taking the first test/placebo product for 3 consecutive days. Participants will complete questionnaires at 30, 60, 90, and 120 minutes after ingestion on Day 1 and Day 3 of ingestion. Participants will have a 3-day washout period before trialing the next test product/placebo.
Following enrollment to the study, participants will abstain from any products containing caffeine, for 3 days.
On the night of the 3rd day of caffeine abstinence, participants will fast overnight (~10 hours) The morning after the fast, participants will complete the Day 1 baseline questionnaire.
Participants will then consume Test Product A and complete questionnaires 30, 60, 90, and 120 minutes after ingestion. Test Products should be consumed in a fasted state, and 1-hour post-ingestion participants will consume a standardized meal (See Section 6.3).
On Day 2, participants will consume Test Product A again but will not complete any questionnaires. The product should be consumed in a fasted state and participants will consume the standardized meal 60 minutes post-ingestion.
On Day 3, participants will consume Test Product A in a fasted state and will again consume the standardized meal 1-hour following ingestion of the product. Participants will complete questionnaires 30, 60, 90, and 120 minutes after ingestion. Participants will then have a 3-day washout period with no products consumed or questionnaires completed.
Following the washout period, the intervention cycle will be repeated with Test Product B and, subsequently, Test Product C.
The questionnaires will consist of study-specific surveys and a cognitive assessment battery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (Dose One) | Experimental | In this crossover trial, all participants will test both active comparators and the placebo comparator. |
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| Intervention (Dose Two) | Experimental | In this crossover trial, all participants will test both active comparators and the placebo comparator. |
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| Placebo | Placebo Comparator | In this crossover trial, all participants will test both active comparators and the placebo comparator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paraxanthine 200 mg | Other | For the three-day test cycle, participants will take one capsule per day amounting to 200mg of paraxanthine. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in scores on a cognitive assessment "Double Trouble". [Time Frame: Baseline to Day 3 of each test cycle] | Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Double Trouble" is a 90-second timed test. Based on a classic Stroop test, Double Trouble measures selective attention, processing speed, and the brain's ability to focus on specific information when presented with conflicting and layered stimuli. | 18 days |
| Changes in scores on a cognitive assessment "Feature Match". [Time Frame: Baseline to Day 3 of each test cycle] | Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Feature Match" is a 90-second timed test. Feature Match is a focus and processing task that requires surveying an increasingly difficult array of information and rapidly assessing the correct response while holding previously processed and detailed information in attention. | 18 days |
| Changes in scores on a cognitive assessment "Grammatical Reasoning". [Time Frame: Baseline to Day 3 of each test cycle] | Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Grammatical Reasoning" is a 90-second timed test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Variation between text and shapes on screen requires holding key information in short-term memory to properly complete the task, leveraging the same parts of the brain that enable an individual to remain focused between varied stimuli. | 18 days |
| Changes in scores on a cognitive assessment "Digit Span". [Time Frame: Baseline to Day 3 of each test cycle] | Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Digit Span is a 3-4 minute performance based test. Increasing in length after each successful attempt, Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly, thereby showing cognitive flexibility and the brain's ability to perform memory and attention-related tasks without error. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of the side effects of caffeine withdrawal. [Baseline to Endline] | Decrease in symptoms of caffeine withdrawal including jitters, fatigue, drowsiness, irritability, "brain fog", and low alertness. This will be reported via participant-reported questionnaires. Incidence and severity of side effects will be reported using a Likert scale (0-5 point scale) with 0=least severe and 5=most severe. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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| ID | Term |
|---|---|
| C021183 | 1,7-dimethylxanthine |
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| Paraxanthine 300 mg | Other | For the three-day test cycle, participants will take one capsule per day amounting to 300mg of paraxanthine. |
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| Placebo | Other | The placebo will contain resistant dextrin. For the three-day test cycle, participants will take one capsule per day amounting to 300mg of resistant dextrin. |
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| 18 days |
| 18 days |