Effect of Different Dosages of Paraxanthine, the Major Caffeine Metabolite, on Energy and Focus
NCT ID: NCT06117280
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2023-07-18
2023-10-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Intervention (Dose One)
In this crossover trial, all participants will test both active comparators and the placebo comparator.
Paraxanthine 200 mg
For the three-day test cycle, participants will take one capsule per day amounting to 200mg of paraxanthine.
Intervention (Dose Two)
In this crossover trial, all participants will test both active comparators and the placebo comparator.
Paraxanthine 300 mg
For the three-day test cycle, participants will take one capsule per day amounting to 300mg of paraxanthine.
Placebo
In this crossover trial, all participants will test both active comparators and the placebo comparator.
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.
Interventions
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Paraxanthine 200 mg
For the three-day test cycle, participants will take one capsule per day amounting to 200mg of paraxanthine.
Paraxanthine 300 mg
For the three-day test cycle, participants will take one capsule per day amounting to 300mg of paraxanthine.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
35 Years
ALL
Yes
Sponsors
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Citruslabs
INDUSTRY
Iovate Health Sciences International Inc
INDUSTRY
Responsible Party
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Locations
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Citruslabs
Santa Monica, California, United States
Countries
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Other Identifiers
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20329
Identifier Type: -
Identifier Source: org_study_id
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