Skip to main content
OpenTrials
Completed

NCT Number: NCT03439111

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biomix

Goyang-si, Gyeonggi-do, 10442, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standardized Lycium chinense Fruit Extract (LCF) capsules

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).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Biomix

Industry

Collaborators

  • Kyunghee University

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 20, 2018
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.