Acute Effects of Paraxanthine on Energy and Focus

NCT06628596 | Completed Phase 1 DMC

• 1 other identifier: IOV-001-032024
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition; Appetite; Mental Energy; Dietary Supplement

Keywords

cognition; appetite; mental energy; mental focus; dietary supplement

Outcome Measures

Primary Outcomes (5)

• 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.

Secondary Outcomes (3)

• Satiety/Feelings of fullness

  Satiety/Feelings of fullness (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.

• Appetite

  Appetite (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.

• Productivity

  Productivity (via visual analogue scale) measured at -30, 0 (meal), and 30, 60, 120, 180 minutes post-meal.

Other Outcomes (1)

• Safety (vital signs, side effect profile/AE monitoring).

  Over the 3.5 hour measurement period

Study Arms (3)

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. * 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.

Dietary Supplement: Paraxanthine 200mg and 300mg

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. * 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.

Dietary Supplement: Paraxanthine 200mg and 300mg

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. * 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.

Dietary Supplement: Paraxanthine 200mg and 300mg

Interventions

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.

Also known as: Placebo (PLA), Paraxanthine 200mg (PXN 200), Paraxanthine 300mg (PXN 300)

Paraxanthine 200mg; Paraxanthine 300mg; Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Biological males and females.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Iovate Health Sciences International Inc: lead

Study Sites (1)

The Center For Applied Health Sciences

Canfield, Ohio, 44406, United States

Location

Related Links

• The Center For Applied Health Sciences Website

MeSH Terms

Interventions

1,7-dimethylxanthine

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: May 7, 2024
• Primary Completion: July 19, 2024
• Study Completion: August 14, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

US (1)