Standardized Lycium Chinense Fruit Extract Enhances Attention and Cognitive Function in Healthy Young People

Study Overview
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Brief Summary
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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
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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.

Official Title
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Standardized Lycium Chinense Fruit Extract Enhances Attention and Cognitive Function in Healthy Young People: A Double-blind, Randomized, Placebo-Controlled, Crossover Trial

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Dietary Supplement: Standardized Lycium chinense Fruit Extract (LCF) capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Intervention : Placebo + Standardized Lycium chinense Fruit Extract (LCF) capsules Placebo Comparator : Oral administration, 600 mg two capsules (600 mg of Starch/capsule) three times a day for 4 week treatment 3 week wash-out Experimental : Oral administration, 600 mg two capsules (146 mg of the Standardized Lycium chinense Fruit Extract (LCF)/capsule) three times a day for 4 week treatment | Dietary Supplement: Standardized Lycium chinense Fruit Extract (LCF) capsules<br>* 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).<br>|
| Experimental: Experimental<br>Intervention : Standardized Lycium chinense Fruit Extract (LCF) capsules + Placebo Experimental : Oral administration, 600 mg two capsules (146 mg of the Standardized Lycium chinense Fruit Extract (LCF)/capsule) three times a day for 4 week treatment 3 week wash-out Placebo Comparator : Oral administration, 600 mg two capsules (600 mg of Starch/capsule) three times a day for 4 week treatment | Dietary Supplement: Standardized Lycium chinense Fruit Extract (LCF) capsules<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Computerized neurocognitive Function Test (CNT) | Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment | Before treatment, 4 and 11 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean version of Attention-deficit/hyperactivity disorder (ADHD) Rating Scale-IV (K-ADHD-RS-IV) | Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment | Before treatment, 4 and 11 weeks after treatment | 
| The Clinical Global Impression (CGI) rating scale | Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment | Before treatment, 4 and 11 weeks after treatment | 
| The Frankfurt Attention Inventory (FAIR) | Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment | Before treatment, 4 and 11 weeks after treatment | 
| Resting-state electroencephalogram (EEG) | Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment | Before treatment, 4 and 11 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lycium chinense fruit