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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Standardized Lycium chinense Fruit Extract (LCF) capsules
Sponsored by
Biomix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Lycium chinense fruit

Eligibility Criteria

14 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Biomix

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Experimental

Arm Description

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

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

Outcomes

Primary Outcome Measures

The Computerized neurocognitive Function Test (CNT)
Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment

Secondary Outcome Measures

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
The Clinical Global Impression (CGI) rating scale
Change of its total score or its subscale score 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
Resting-state electroencephalogram (EEG)
Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment

Full Information

First Posted
February 1, 2018
Last Updated
February 21, 2018
Sponsor
Biomix
Collaborators
Kyunghee University
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1. Study Identification

Unique Protocol Identification Number
NCT03439111
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2011 (Actual)
Primary Completion Date
April 30, 2013 (Actual)
Study Completion Date
April 30, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biomix
Collaborators
Kyunghee University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Lycium chinense fruit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Standardized Lycium chinense Fruit Extract (LCF) capsules
Intervention Description
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).
Primary Outcome Measure Information:
Title
The Computerized neurocognitive Function Test (CNT)
Description
Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment
Time Frame
Before treatment, 4 and 11 weeks after treatment
Secondary Outcome Measure Information:
Title
Korean version of Attention-deficit/hyperactivity disorder (ADHD) Rating Scale-IV (K-ADHD-RS-IV)
Description
Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment
Time Frame
Before treatment, 4 and 11 weeks after treatment
Title
The Clinical Global Impression (CGI) rating scale
Description
Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment
Time Frame
Before treatment, 4 and 11 weeks after treatment
Title
The Frankfurt Attention Inventory (FAIR)
Description
Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment
Time Frame
Before treatment, 4 and 11 weeks after treatment
Title
Resting-state electroencephalogram (EEG)
Description
Change of its total score or its subscale score before treatment, 4 and 11 weeks after treatment
Time Frame
Before treatment, 4 and 11 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Hun Cho, KMD., Ph.D.
Organizational Affiliation
Kyunghee University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biomix
City
Goyang-si
State/Province
Kyunggi-do
ZIP/Postal Code
10442
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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