Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03439111
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Kyunghee University
Information provided by (Responsible Party):
Biomix

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Dietary Supplement: Standardized Lycium chinense Fruit Extract (LCF) capsules Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Standardized Lycium Chinense Fruit Extract Enhances Attention and Cognitive Function in Healthy Young People: A Double-blind, Randomized, Placebo-Controlled, Crossover Trial
Actual Study Start Date : November 1, 2011
Actual Primary Completion Date : April 30, 2013
Actual Study Completion Date : April 30, 2013

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439111


Locations
Layout table for location information
Korea, Republic of
Biomix
Goyang-si, Kyunggi-do, Korea, Republic of, 10442
Sponsors and Collaborators
Biomix
Kyunghee University
Investigators
Layout table for investigator information
Principal Investigator: Seung-Hun Cho, KMD., Ph.D. Kyunghee University
Layout table for additonal information
Responsible Party: Biomix
ClinicalTrials.gov Identifier: NCT03439111    
Other Study ID Numbers: KOMCGIRB-2013-88
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biomix:
Lycium chinense fruit
Additional relevant MeSH terms:
Layout table for MeSH terms
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders