NCT06628596

Acute Effects of Paraxanthine on Energy and Focus

Acute Effects of Paraxanthine on Energy, Focus, Appetite, and Cognition: Double-Blind, Placebo-Controlled Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Iovate Health Sciences International Inc · Industry
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the effects of paraxanthine (200 mg and 300 mg) on energy, focus, appetite, and cognitive performance in healthy adults. Using a double-blind, placebo-controlled, crossover design, participants will receive paraxanthine or placebo 30 minutes before a meal. Cognition tests and visual Analogue Scale (VAS) ratings for energy, focus, productivity, satiety, and appetite will be collected at multiple time points post-consumption.

Detailed description

Caffeine (CAF) is one of the most consumed naturally occurring nootropic and exercise-related ergogenic aids. Paraxanthine (1,7-dimethylxanthine, PXN) is the main metabolite of CAF, accounting for 70-72% of CAF ingested, and 85% of the methylxanthine metabolic by-products. While caffeine has been extensively studied for its effects on energy, and focus in humans, the effects of paraxanthine are less understood. It was recently reported that acute ingestion of PXN enhances various markers of focus such as memory, reaction time, and attention for up to 6-hours in healthy adults, and that acute ingestion as low as 50 mg of PXN for 7-days enhanced measures of cognition, memory, reasoning, response time, and helped sustain attention. While studies were performed in the fasted state and over 6 hours which is beyond the \~3.1h half-life of paraxanthine, the cognitive effects of paraxanthine in response to an ecologically valid meal over a 3-hour period is limited. Therefore, the purpose of this study is to assess the impact of paraxanthine on energy, focus, and cognition in younger healthy adults in the fed state.

Conditions

• Cognition
• Appetite
• Mental Energy
• Dietary Supplement

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Paraxanthine 200mg and 300mg	Participants consumed 200 mg paraxanthine (PXN 200), 300 mg paraxanthine (PXN 300), or placebo (PLA) after an overnight fast. Supplements were ingested 30 minutes before a mixed meal in double-blind, randomized, placebo-controlled, crossover fashion.

Timeline

• Start date: 2024-05-07
• Primary completion: 2024-07-19
• Completion: 2024-08-14
• First posted: 2024-10-08
• Last updated: 2024-10-08

Locations

1 site across 1 country: United States