Attention Deficit Hyperactivity Disorder
Conditions
Keywords
Lycium chinense fruit
Brief summary
Lycium chinense fruit (LCF) is widely distributed in East Asia that has been used traditionally for anti-aging purposes. This study was performed to examine the effects of LCF on attention and cognitive function in healthy young people. An 11-week, double-blind, randomized, placebo-controlled, crossover trial was conducted.
Detailed description
The Computerized Neurocognitive function Test (CNT), the Korean version of the Attention-deficit/hyperactivity disorder (ADHD) Rating Scale-IV (K-ADHD-RS-IV), the Clinical Global Impression (CGI) rating scale, the Frankfurt Attention Inventory (FAIR), and resting-state electroencephalogram (EEG) were conducted before and after the experiment.
Interventions
DIETARY_SUPPLEMENTStandardized Lycium chinense Fruit Extract (LCF) capsules
All dried water extracts and capsules of the Standardized Lycium chinense Fruit Extract (LCF) and Standardized Lycium chinense Fruit Extract (LCF)-matched placebo capsules used in the present study were manufactured and provided by the BIOMIX Company (Ilsan City, Korea).
Sponsors
Kyunghee University
Biomix
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study
Eligibility
Sex/Gender
ALL
Age
14 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 14 and 24 years old * Male or female * Ability to understand the objectives of the study and agreed to abide by the required rules during the study. * If participants were aged between 14 and 20 years old, they and their parents had to provide informed consent.
Exclusion criteria
* Diagnosis of ADHD (any subtype) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria * Diagnosis of a developmental disorder * Pregnant or breastfeeding women and women with the possibility of getting pregnant * Gastrointestinal disease or history of gastrointestinal surgery, which might affect the absorption of study materials * Significant neurological (epilepsy, mental retardation, or stroke) or medical illnesses (diabetes, hypertension, or cardiovascular diseases), * Participation in other clinical studies during the four weeks preceding the start of the study * More than 1.5 times normal limit of ALT or AST.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Computerized neurocognitive Function Test (CNT) | Before treatment, 4 and 11 weeks after treatment | Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Korean version of Attention-deficit/hyperactivity disorder (ADHD) Rating Scale-IV (K-ADHD-RS-IV) | Before treatment, 4 and 11 weeks after treatment | Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment |
| The Clinical Global Impression (CGI) rating scale | Before treatment, 4 and 11 weeks after treatment | Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment |
| The Frankfurt Attention Inventory (FAIR) | Before treatment, 4 and 11 weeks after treatment | Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment |
| Resting-state electroencephalogram (EEG) | Before treatment, 4 and 11 weeks after treatment | Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment |
Countries
South Korea
Outcome results
None listed