Effects of L-theanine and Caffeine on Attention and Attention-related Brain Activity of Children With Attention Deficit Hyperactivity Disorder
NCT03533556 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2019-04-12
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
- Attention Deficit Hyperactivity Disorder
Interventions
- DIETARY_SUPPLEMENT
-
L-theanine
Oral administration of 2.5 mg/kg body weight of L-theanine dissolved in 100 ml of water
- DIETARY_SUPPLEMENT
-
Caffeine
Oral administration of 2.0 mg/kg body weight of caffeine dissolved in 100 ml of water
- DIETARY_SUPPLEMENT
-
L-theanine-Caffeine Combination
Oral administration of a combination of 2.5 mg/kg body weight of L-theanine and 2.0 mg/kg body weight of caffeine dissolved in 100 ml of water
- OTHER
-
Placebo
Oral administration of 100 ml of water
Sponsors & Collaborators
-
Texas Tech University Health Sciences Center
collaborator OTHER -
Texas Tech University
lead OTHER
Principal Investigators
-
Chanaka Kahathuduwa, MBBS PhD · Texas Tech University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 8 Years
- Max Age
- 17 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-05-14
- Primary Completion
- 2018-08-31
- Completion
- 2018-08-31
Countries
- United States
Study Locations
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