Effect of Different Dosages of Paraxanthine, the Major Caffeine Metabolite, on Energy and Focus

NCT06117280 | Completed

• 1 other identifier: 20329
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Research has shown that acute ingestion of Paraxanthine (1,7-dimethylxanthine, PXN) can enhance various markers of focus, including memory, reaction time, and attention in healthy adults. To assess these effects, this placebo-controlled crossover trial will compare the effects of 200 and 300mg of PXN to a placebo control. Participants will abstain from caffeine for 3 days, before taking the first test/placebo product for 3 consecutive days. Participants will complete questionnaires at 30, 60, 90, and 120 minutes after ingestion on Day 1 and Day 3 of ingestion. Participants will have a 3-day washout period before trialing the next test product/placebo.

Conditions

Energy; Focus; Caffeine Withdrawal

Outcome Measures

Primary Outcomes (4)

• Changes in scores on a cognitive assessment "Double Trouble". [Time Frame: Baseline to Day 3 of each test cycle]

  Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Double Trouble" is a 90-second timed test. Based on a classic Stroop test, Double Trouble measures selective attention, processing speed, and the brain's ability to focus on specific information when presented with conflicting and layered stimuli.

  18 days

• Changes in scores on a cognitive assessment "Feature Match". [Time Frame: Baseline to Day 3 of each test cycle]

  Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Feature Match" is a 90-second timed test. Feature Match is a focus and processing task that requires surveying an increasingly difficult array of information and rapidly assessing the correct response while holding previously processed and detailed information in attention.

  18 days

• Changes in scores on a cognitive assessment "Grammatical Reasoning". [Time Frame: Baseline to Day 3 of each test cycle]

  Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Grammatical Reasoning" is a 90-second timed test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Variation between text and shapes on screen requires holding key information in short-term memory to properly complete the task, leveraging the same parts of the brain that enable an individual to remain focused between varied stimuli.

  18 days

• Changes in scores on a cognitive assessment "Digit Span". [Time Frame: Baseline to Day 3 of each test cycle]

  Participants will independently complete a cognitive assessment battery at home on their computer or tablet. "Digit Span is a 3-4 minute performance based test. Increasing in length after each successful attempt, Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly, thereby showing cognitive flexibility and the brain's ability to perform memory and attention-related tasks without error.

  18 days

Secondary Outcomes (1)

• Occurence of the side effects of caffeine withdrawal. [Baseline to Endline]

  18 days

Study Arms (3)

Intervention (Dose One)

EXPERIMENTAL

In this crossover trial, all participants will test both active comparators and the placebo comparator.

Other: Paraxanthine 200 mg

Intervention (Dose Two)

EXPERIMENTAL

In this crossover trial, all participants will test both active comparators and the placebo comparator.

Other: Paraxanthine 300 mg

Placebo

PLACEBO COMPARATOR

In this crossover trial, all participants will test both active comparators and the placebo comparator.

Other: Placebo

Interventions

Paraxanthine 200 mg OTHER

For the three-day test cycle, participants will take one capsule per day amounting to 200mg of paraxanthine.

Intervention (Dose One)

Paraxanthine 300 mg OTHER

For the three-day test cycle, participants will take one capsule per day amounting to 300mg of paraxanthine.

Intervention (Dose Two)

Placebo OTHER

The placebo will contain resistant dextrin. For the three-day test cycle, participants will take one capsule per day amounting to 300mg of resistant dextrin.

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18-35
• Willing to abstain from caffeine-containing beverages and foods during the duration of the study
• Recreationally active; currently performing structured exercise (e.g., running, weightlifting, team-sport activity) at least 2 days per week for the previous 3 months

You may not qualify if:

• Body Mass Index: \>29.9kg/m2
• Inability to adhere to protocol guidelines (e.g., caffeine, alcohol, tobacco)
• Regular tobacco use
• Illicit drug use (e.g., growth hormone, testosterone, etc.)
• A diagnosed medical condition under the care of a physician (e.g. type 2 diabetes) Inability to abstain from supplements (e.g. protein, creatine, HMB, BCAA, phosphatidic acid, etc.) at least three weeks before the trial
• Individuals on medications known to affect caffeine metabolism (e.g., corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)
• Participants who are amenorrheic (females only)
• Inability to comply with the study protocol as judged by the investigators

Sponsors & Collaborators

• Iovate Health Sciences International Inc: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Interventions

1,7-dimethylxanthine

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 7, 2023
• Study Start: July 18, 2023
• Primary Completion: October 18, 2023
• Study Completion: October 20, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

US (1)