Health TrialsbyHealthPanel

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

ConditionsAttention Deficit Hyperactivity Disorder (ADHD)Autism Spectrum Disorder (ASD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorTexas Tech University Health Sciences Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Subjects with gross visual or auditory impairments that might limit their ability to perform neuropsychological tasks

Inability to read and follow written instructions

Physical, neurological, intellectual, or psychiatric impairments (except ADHD or ASD) that could affect cognitive and motor functions

Subjects on medications including antidepressants and antipsychotics that may affect performance in the tasks

Trial design

Design model

Crossover

Treatments tested in this trial

  • L-theanine and paraxanthine

    Dietary supplement

    200 mg L-theanine + 200 mg paraxanthine capsule

  • Placebo

    Dietary supplement

    400 mg corn starch capsule

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Attention deficit hyperactivity disorder (ADHD)Experimental treatment 2 interventions
Group B: Autism spectrum disorder (ASD)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

fMRI task-related activity

fMRI task-related activity in default mode and central executive networks during Go/NoGo and Stop-Signal tasks.

Time frame
At visit 2 or 3, 30 minutes after intake of L-theanine-paraxanthine or placebo.
2

Stop Signal Reaction Time

Estimated time (milliseconds) required to inhibit a prepotent response following a stop signal, computed using the horse-race model and drift-diffusion theory. Lower values indicate better inhibitory control.

Time frame
At visit 2 or 3, 30 minutes after intake of L-theanine-paraxanthine or placebo. This task is performed while in the MRI.
3

d-prime (sensitivity to the Go signal)

d-prime on Go/No-Go task computed using the signal detection theory.

Time frame
At visit 2 or 3, 30 minutes after intake of L-theanine-paraxanthine or placebo. This task is performed while in the MRI.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Texas Tech University Health Sciences Center

Lead sponsor

Texas Tech University

Collaborator

Source ClinicalTrials.gov
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