NCT03533556

Effects of L-theanine and Caffeine on Attention and Attention-related Brain Activity of Children With Attention Deficit Hyperactivity Disorder

Completed EARLY_PHASE1 Last updated 12 April 2019

What this trial tests

EARLY_PHASE1 trial testing L-theanine in Attention Deficit Hyperactivity Disorder in 6 participants. Completed in 31 August 2018.

Timeline

14 May 2018

Primary endpoint
31 August 2018

31 August 2018

Quick facts

Lead sponsor	Texas Tech University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	6
Start date	14 May 2018
Primary completion	31 August 2018
Estimated completion	31 August 2018
Sites	1 location across United States

Drugs / interventions tested

• L-theanine — full drug profile →
• Caffeine (caffeine) — full drug profile →
• L-theanine-Caffeine Combination
• Placebo

Conditions studied

• Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →

Sponsor

Texas Tech University

Who can join

Adults 8 to 17, male only, with Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of L-theanine-caffeine combination on sustained attention and inhibitory control among children with ADHD: a proof-of-concept neuroimaging RCT.
   Kahathuduwa CN, Wakefield S, West BD, Blume J, et al · · 2020 · cited 25× · PMID 32753637 · DOI 10.1038/s41598-020-70037-7