Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03533556 · ClinicalTrials.gov registry record · Early Phase 1
Effects of L-theanine and Caffeine on Attention and Attention-related Brain Activity of Children With Attention Deficit Hyperactivity Disorder
A Early Phase 1 study of Attention Deficit Hyperactivity Disorder, sponsored by Texas Tech University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT03533556 is a Early Phase 1 study of Attention Deficit Hyperactivity Disorder that has completed, run by Texas Tech University. The registered enrollment target is 6 participants, below the 207-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03533556, a Early Phase 1 study of Attention Deficit Hyperactivity Disorder, has completed, sponsored by Texas Tech University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
L-theanine and caffeine are two natural constituents of tea. Both of these compounds are among the U.S. Food and Drug Administration's list of Generally Recognized as Safe (GRAS) substances. Results of several clinical trials the PI and his team has conducted are consistent with results of many others to indicate that oral intake of each of 2.5 mg/kg body weight of L-theanine and 2.0 mg/kg body weight of caffeine is associated with improved attention in adults. Furthermore, there is evidence to suggest that, when taken in combination, L-theanine and caffeine seem to have additive effects in improving attention in adults. However, the specific actions of these substances have not been examined in children and adolescents with attention deficit hyperactivity disorder (ADHD), who are characterized by impaired attention, hyperkinesia and impulsivity. Therefore, the investigators plan to study the functional activity of brains (both at rest and when performing standard tasks designed to measure attention) in children diagnosed with ADHD using functional magnetic resonance imaging, after they consume either 2.5 mg/kg of L-theanine, 2.0 mg/kg of caffeine and their combination as compared to a placebo (water). Based on our previous findings, the investigators expect to observe improvements (speed of responding and accuracy) in standard tests of attention with intake of L-theanine, caffeine and their combination as compared to the placebo. The investigators also expect to observe decreased functional activity in brain regions that typically show increased activity during mind wandering with intake of L-theanine, caffeine and their combination.
Conditions Studied
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT L-theanine
- DIETARY_SUPPLEMENT Caffeine
- DIETARY_SUPPLEMENT L-theanine-Caffeine Combination
Study Locations (1)
Texas
- Texas Tech University - Department of Human Development and Family Studies - Lubbock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-05-14 |
| Est. Completion | 2018-08-31 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03533556
The ClinicalTrials.gov registry entry for NCT03533556 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (97% lower). The listed sponsor is Texas Tech University, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT03533556 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT03533556 about?
NCT03533556 is a clinical study titled "Effects of L-theanine and Caffeine on Attention and Attention-related Brain Activity of Children With Attention Deficit Hyperactivity Disorder". L-theanine and caffeine are two natural constituents of tea. Both of these compounds are among the U.S. Food and Drug Administration's list of Generally Recognized as Safe (GRAS) substances. Results of several clinical trials the PI and his team has conducted are consistent with results of many othe...
What is the current status of trial NCT03533556?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2018-05-14. Estimated completion is 2018-08-31.
What conditions does trial NCT03533556 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.
What interventions are being tested in trial NCT03533556?
The interventions under investigation include: Placebo (OTHER), L-theanine (DIETARY_SUPPLEMENT), Caffeine (DIETARY_SUPPLEMENT), L-theanine-Caffeine Combination (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03533556?
This trial is sponsored by Texas Tech University, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03533556 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Attention Deficit Hyperactivity Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Eye Tracking as a Predictor of Methylphenidate Response in Autism With ADHD
COMPLETED · Early Phase 1
-
Mindfulness-Based ADHD Treatment for Children: a Feasibility Study
COMPLETED · Early Phase 1
-
Developing Brain, Impulsivity and Compulsivity
RECRUITING
-
HOPS Study: A Conceptual Replication
RECRUITING · NA
-
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
RECRUITING · Phase 4
-
COMT Inhibition Among Individuals With Comorbid AUD/ADHD
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.