Clinical trial NCT06117280: Effect of Different Dosages of Paraxanthine, the Major Caffeine Metabolite, on Energy and Focus
Official title: Effect of Different Dosages of Paraxanthine, the Major Caffeine Metabolite, on Energy and Focus: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy
Focus
Caffeine Withdrawal
Lead sponsor: Iovate Health Sciences International Inc
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-11-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in scores on a cognitive assessment "Double Trouble". [Time Frame: Baseline to Day 3 of each test cycle]
timeFrame: 18 days
measure: Changes in scores on a cognitive assessment "Feature Match". [Time Frame: Baseline to Day 3 of each test cycle]
timeFrame: 18 days
measure: Changes in scores on a cognitive assessment "Grammatical Reasoning". [Time Frame: Baseline to Day 3 of each test cycle]
timeFrame: 18 days
measure: Changes in scores on a cognitive assessment "Digit Span". [Time Frame: Baseline to Day 3 of each test cycle]
timeFrame: 18 days
Secondary outcomes:
measure: Occurence of the side effects of caffeine withdrawal. [Baseline to Endline]
timeFrame: 18 days
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: