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

NCT ID: NCT03439111

Last Updated: 2018-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-01

Study Completion Date

2013-04-30

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.

Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Standardized Lycium chinense Fruit Extract (LCF) capsules

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type EXPERIMENTAL

Standardized Lycium chinense Fruit Extract (LCF) capsules

Intervention Type DIETARY_SUPPLEMENT

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).

Interventions

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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).

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kyunghee University

OTHER

Sponsor Role collaborator

Biomix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seung-Hun Cho, KMD., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kyunghee University

Locations

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Biomix

Goyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KOMCGIRB-2013-88

Identifier Type: -

Identifier Source: org_study_id

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