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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: April 30, 2013

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 Supplement: Standardized 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).

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • 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
  • Experimental: Experimental
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • The Computerized neurocognitive Function Test (CNT)
    • Time Frame: 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 Measures

  • Korean version of Attention-deficit/hyperactivity disorder (ADHD) Rating Scale-IV (K-ADHD-RS-IV)
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 24 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Biomix
  • Collaborator
    • Kyunghee University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Seung-Hun Cho, KMD., Ph.D., Principal Investigator, Kyunghee University

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