Effect of Different Dosages of Paraxanthine, the Major Caffeine Metabolite, on Energy and Focus
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention (Dose One) In this crossover trial, all participants will test both active comparators and the placebo comparator. |
Other: Paraxanthine 200 mg
For the three-day test cycle, participants will take one capsule per day amounting to 200mg of paraxanthine.
|
| Experimental: Intervention (Dose Two) In this crossover trial, all participants will test both active comparators and the placebo comparator. |
Other: Paraxanthine 300 mg
For the three-day test cycle, participants will take one capsule per day amounting to 300mg of paraxanthine.
|
| Placebo Comparator: Placebo In this crossover trial, all participants will test both active comparators and the placebo comparator. |
Other: Placebo
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.
|
Outcome Measures
Primary Outcome Measures
- Changes in scores on a cognitive assessment "Double Trouble". [Time Frame: Baseline to Day 3 of each test cycle] [18 days]
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.
- Changes in scores on a cognitive assessment "Feature Match". [Time Frame: Baseline to Day 3 of each test cycle] [18 days]
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.
- Changes in scores on a cognitive assessment "Grammatical Reasoning". [Time Frame: Baseline to Day 3 of each test cycle] [18 days]
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.
- Changes in scores on a cognitive assessment "Digit Span". [Time Frame: Baseline to Day 3 of each test cycle] [18 days]
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.
Secondary Outcome Measures
- Occurence of the side effects of caffeine withdrawal. [Baseline to Endline] [18 days]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged between 18-35
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Willing to abstain from caffeine-containing beverages and foods during the duration of the study
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Recreationally active; currently performing structured exercise (e.g., running, weightlifting, team-sport activity) at least 2 days per week for the previous 3 months
Exclusion Criteria:
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Body Mass Index: >29.9kg/m2
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Inability to adhere to protocol guidelines (e.g., caffeine, alcohol, tobacco)
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Regular tobacco use
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Illicit drug use (e.g., growth hormone, testosterone, etc.)
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A diagnosed medical condition under the care of a physician (e.g. type 2 diabetes) Inability to abstain from supplements (e.g. protein, creatine, HMB, BCAA, phosphatidic acid, etc.) at least three weeks before the trial
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Individuals on medications known to affect caffeine metabolism (e.g., corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)
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Participants who are amenorrheic (females only)
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Inability to comply with the study protocol as judged by the investigators
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Citruslabs | Santa Monica | California | United States | 90404 |
Sponsors and Collaborators
- Iovate Health Sciences International Inc
- Citruslabs
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20329