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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03439111
• Other study ID #: KOMCGIRB-2013-88
• Status: Completed
• Phase: N/A
• First received: February 1, 2018
• Last updated: February 21, 2018
• Start date: November 1, 2011
• Est. completion date: April 30, 2013

Study information

• Verified date: February 2018
• Source: Biomix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 30, 2013
• Est. primary completion date: April 30, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Biomix	Goyang-si	Kyunggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Biomix	Kyunghee University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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