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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Iovate Health Sciences International Inc · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Energy
• Focus
• Caffeine Withdrawal

Interventions

Type	Name	Description
OTHER	Paraxanthine 200 mg	For the three-day test cycle, participants will take one capsule per day amounting to 200mg of paraxanthine.
OTHER	Paraxanthine 300 mg	For the three-day test cycle, participants will take one capsule per day amounting to 300mg of paraxanthine.
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.

Timeline

• Start date: 2023-07-18
• Primary completion: 2023-10-18
• Completion: 2023-10-20
• First posted: 2023-11-07
• Last updated: 2023-11-07

Locations

1 site across 1 country: United States