Acute Effects of Paraxanthine on Energy and Focus (PXN)

Iovate Health Sciences

Status and phase

Completed

Phase 2

Phase 1

Conditions

Cognition

Mental Energy

Dietary Supplement

Appetite

Treatments

Dietary Supplement: Paraxanthine 200mg and 300mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT06628596

IOV-001-032024

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

25 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

After qualifying for the study, subjects will be randomly assigned to receive a placebo, 200mg PXN, and 300mg PXN using a Latin Square design. * Paraxanthine (200 mg) * Paraxanthine (300 mg) * Placebo (containing 300mg resistant starch) •Supplements will be provided in identical-looking capsules with label directions and Study Protocol Number.

Treatment:

Dietary Supplement: Paraxanthine 200mg and 300mg

Paraxanthine 200mg

Active Comparator group

Description:

Treatment:

Dietary Supplement: Paraxanthine 200mg and 300mg

Paraxanthine 300mg

Active Comparator group

Description:

Treatment:

Dietary Supplement: Paraxanthine 200mg and 300mg