L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD

Part of paid clinical trials in Lubbock, Texas.

Sponsor
Texas Tech University Health Sciences Center
Study ID
NCT07189442
Status
Recruiting
Apply to this trial

Conditions

  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Autism Spectrum Disorder (ASD)

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • L-theanine and paraxanthine — DIETARY_SUPPLEMENT
    200 mg L-theanine + 200 mg paraxanthine capsule
  • Placebo — DIETARY_SUPPLEMENT
    400 mg corn starch capsule

Study Details

This pilot study will test whether combining L-theanine and paraxanthine improves sustained attention, inhibitory control, and overall cognition in adults with ADHD and ASD. Two parallel randomized, single-blinded, repeated-measures crossover trials will be conducted. Participants will complete neuropsychological testing, fMRI scanning, and self-report measures following administration of the L-theanine-paraxanthine combination compared to placebo.

Key Dates

Start date
Oct 1, 2025
Status verified
Feb 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Attention deficit hyperactivity disorder (ADHD)
    A group of 12 adult males with Attention Deficit Hyperactivity Disorder (ADHD) will be enrolled. Each participant will receive both study conditions in a randomized, single-blinded, repeated-measures crossover design: Active Condition: One capsule containing 200 mg L-theanine + 200 mg paraxanthine. Placebo Condition: One capsule containing 400 mg of corn starch. The order of administration will be randomized, with each participant completing both conditions on separate visits (visits 2 and 3).
  • Experimental: Autism spectrum disorder (ASD)
    A group of 12 adult males with autism spectrum disorder (ASD) will be enrolled. Each participant will receive both study conditions in a randomized, single-blinded, repeated-measures crossover design: Active Condition: One capsule containing 200 mg L-theanine + 200 mg paraxanthine. Placebo Condition: One capsule containing 400 mg of corn starch. The order of administration will be randomized, with each participant completing both conditions on separate visits (visits 2 and 3).

Primary Outcome Measure

fMRI task-related activity [ Time Frame: At visit 2 or 3, 30 minutes after intake of L-theanine-paraxanthine or placebo. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Tech UniversityLubbockTexas79430
Ann Mastergeorge, PhD
[email protected]
806-834-7162
Chathurika S Dhanasekara, MBBS, PhD
[email protected]
806-743-2378

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