Clinical trial NCT06628596: Acute Effects of Paraxanthine on Energy and Focus
Official title: Acute Effects of Paraxanthine on Energy, Focus, Appetite, and Cognition: Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cognition
Appetite
Mental Energy
Dietary Supplement
Keywords: cognition
appetite
mental energy
mental focus
dietary supplement
Lead sponsor: Iovate Health Sciences International Inc
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Voluntarily provide signed and dated informed consent.
* Be in good health as determined by medical history and routine blood chemistries.
* Age between 20 and 40 years (inclusive).
* Body Mass Index of 18.5-29.9 (inclusive).
* Body weight of at least 120 pounds.
* Normotensive (supine, resting systolic blood pressure \<140 mm Hg and diastolic blood pressure \< 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
* Normal supine, resting heart rate (\< 90 per minute).
* Willing to duplicate their previous 24-hour diet, refrain from alcohol, caffeine, and exercise for 24 hr prior to each trial, and fast for 8 hours prior to each trial.

Exclusion Criteria:

* Current smoker or other nicotine use (i.e. vape, patch, etc.).
* History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
* Prior gastrointestinal bypass surgery (Lapband, etc.).
* Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU).
* Chronic inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
* History of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
* History of cognitive disorder.
* History of psychiatric disorder.
* Known sensitivity to any ingredient in the test formulations as listed in the Certificates-of-Analysis.
* Women currently pregnant, trying to become pregnant or breastfeeding a child.
* Use of anxiety or ADHD medication.
* Caffeine intake of three or more cups of coffee or equivalent (\>400 mg) per day.
* Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence.
* Clinically significant abnormal laboratory results at screening.
* Prior gastrointestinal bypass surgery (Lapband, etc.).
* Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
* Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate.

Primary outcomes:
measure: Energy
timeFrame: Energy (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.
measure: Focus
timeFrame: Focus (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.
measure: N-Back Task
timeFrame: 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: Go/No-Go Task
timeFrame: 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: Serial 7s
timeFrame: 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.
Secondary outcomes:
measure: Satiety/Feelings of fullness
timeFrame: Satiety/Feelings of fullness (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.
measure: Appetite
timeFrame: Appetite (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.
measure: Productivity
timeFrame: Productivity (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.
Other outcomes:
measure: Safety (vital signs, side effect profile/AE monitoring).
timeFrame: Over the 3.5 hour measurement period
Locations:
city: Canfield
country: United States
facility: The Center For Applied Health Sciences
state: Ohio
Study officials:
References: