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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.
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.
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| Label | Type | Description | Intervention Names |
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| Placebo | Placebo Comparator | After qualifying for the study, subjects will be randomly assigned to receive a placebo, 200mg PXN, and 300mg PXN using a Latin Square design.
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| Paraxanthine 200mg | Active Comparator | After qualifying for the study, subjects will be randomly assigned to receive a placebo, 200mg PXN, and 300mg PXN using a Latin Square design.
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| Paraxanthine 300mg | Active Comparator | After qualifying for the study, subjects will be randomly assigned to receive a placebo, 200mg PXN, and 300mg PXN using a Latin Square design.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paraxanthine 200mg and 300mg | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Energy | Using 100 mm anchored visual analogue scale. Higher scores indicate an improvement. | Energy (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal. |
| Focus | Using 100 mm anchored visual analogue scale. Higher scores indicate an improvement. | Focus (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal. |
| N-Back Task | Two repetitions of the N-Back Task (90s in duration) to assess memory, attention and decision making | Assessed at t = - 30min (prior to study product ingestion) and at t = 0 min immediately before the standardized mealand 30-, 60-, 120-, and 180 minutes post meal ingestion. |
| Go/No-Go Task | Two repetitions of the Go/No-Go Task (90s in duration) to assess measures of attention, processing speed and impulse control | Assessed at t = - 30min (prior to study product ingestion) and at t = 0 min immediately before the standardized mealand 30-, 60-, 120-, and 180 minutes post meal ingestion. |
| Serial 7s | Two repetitions of Serial 7s (90s in duration) to assess attention, working memory, and mental arithmetic's. | Assessed at t = - 30min (prior to study product ingestion) and at t = 0 min immediately before the standardized mealand 30-, 60-, 120-, and 180 minutes post meal ingestion. |
| Measure | Description | Time Frame |
|---|---|---|
| Satiety/Feelings of fullness | Using 100 mm anchored visual analogue scale. Higher scores indicate an improvement. | Satiety/Feelings of fullness (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal. |
| Appetite |
| Measure | Description | Time Frame |
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| Safety (vital signs, side effect profile/AE monitoring). | Questionnaire | Over the 3.5 hour measurement period |
Inclusion Criteria:
Exclusion Criteria:
Biological males and females.
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| Facility | Status | City | State | ZIP | Country | Contacts |
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| The Center For Applied Health Sciences | Canfield | Ohio | 44406 | United States |
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| Label | URL |
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| The Center For Applied Health Sciences Website | View source |
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Case by case basis.
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| ID | Term |
|---|---|
| C021183 | 1,7-dimethylxanthine |
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Using 100 mm anchored visual analogue scale. Higher scores indicate an improvement.
| Appetite (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal. |
| Productivity | Using 100 mm anchored visual analogue scale. Higher scores indicate an improvement. | Productivity (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal. |