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

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Dietary supplement: Standardized Lycium chinense Fruit Extract (LCF) capsules

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyunggi-do
    • Goyang-si, Kyunggi-do, Korea, Republic of, 10442
      • Biomix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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).
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	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Biomix
• Collaborators: Kyunghee University
• Investigators: Principal Investigator: Seung-Hun Cho, KMD., Ph.D., Kyunghee University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Actual): April 30, 2013
• Study Completion (Actual): April 30, 2013

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Lycium chinense fruit
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: KOMCGIRB-2013-88

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No