Clinical trial NCT03439111: Standardized Lycium Chinense Fruit Extract Enhances Attention and Cognitive Function in Healthy Young People
Official title: Standardized Lycium Chinense Fruit Extract Enhances Attention and Cognitive Function in Healthy Young People: A Double-blind, Randomized, Placebo-Controlled, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Lycium chinense fruit
Lead sponsor: Biomix
Sponsor class: INDUSTRY
Collaborators: name: Kyunghee University
First posted: 2018-02-20
Enrollment: 75
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Computerized neurocognitive Function Test (CNT)
timeFrame: Before treatment, 4 and 11 weeks after treatment
Secondary outcomes:
measure: Korean version of Attention-deficit/hyperactivity disorder (ADHD) Rating Scale-IV (K-ADHD-RS-IV)
timeFrame: Before treatment, 4 and 11 weeks after treatment
measure: The Clinical Global Impression (CGI) rating scale
timeFrame: Before treatment, 4 and 11 weeks after treatment
measure: The Frankfurt Attention Inventory (FAIR)
timeFrame: Before treatment, 4 and 11 weeks after treatment
measure: Resting-state electroencephalogram (EEG)
timeFrame: Before treatment, 4 and 11 weeks after treatment
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Biomix
state: Kyunggi-do
Study officials:
affiliation: Kyunghee University
name: Seung-Hun Cho, KMD., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: