- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06117280
Effect of Different Dosages of Paraxanthine, the Major Caffeine Metabolite, on Energy and Focus
Effect of Different Dosages of Paraxanthine, the Major Caffeine Metabolite, on Energy and Focus: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Santa Monica, California, United States, 90404
- Citruslabs
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 18-35
- Willing to abstain from caffeine-containing beverages and foods during the duration of the study
- 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:
- Body Mass Index: >29.9kg/m2
- Inability to adhere to protocol guidelines (e.g., caffeine, alcohol, tobacco)
- Regular tobacco use
- Illicit drug use (e.g., growth hormone, testosterone, etc.)
- 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
- Individuals on medications known to affect caffeine metabolism (e.g., corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)
- Participants who are amenorrheic (females only)
- Inability to comply with the study protocol as judged by the investigators
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention (Dose One)
In this crossover trial, all participants will test both active comparators and the placebo comparator.
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For the three-day test cycle, participants will take one capsule per day amounting to 200mg of paraxanthine.
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Experimental: Intervention (Dose Two)
In this crossover trial, all participants will test both active comparators and the placebo comparator.
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For the three-day test cycle, participants will take one capsule per day amounting to 300mg of paraxanthine.
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Placebo Comparator: Placebo
In this crossover trial, all participants will test both active comparators and the placebo comparator.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in scores on a cognitive assessment "Double Trouble". [Time Frame: Baseline to Day 3 of each test cycle]
Time Frame: 18 days
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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.
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18 days
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Changes in scores on a cognitive assessment "Feature Match". [Time Frame: Baseline to Day 3 of each test cycle]
Time Frame: 18 days
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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.
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18 days
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Changes in scores on a cognitive assessment "Grammatical Reasoning". [Time Frame: Baseline to Day 3 of each test cycle]
Time Frame: 18 days
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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.
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18 days
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Changes in scores on a cognitive assessment "Digit Span". [Time Frame: Baseline to Day 3 of each test cycle]
Time Frame: 18 days
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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.
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18 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurence of the side effects of caffeine withdrawal. [Baseline to Endline]
Time Frame: 18 days
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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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18 days
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Purinergic Antagonists
- Purinergic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Theophylline
Other Study ID Numbers
- 20329
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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