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

NCT03439111 | Completed DMC

• 1 other identifier: KOMCGIRB-2013-88
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Lycium chinense fruit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Korean version of Attention-deficit/hyperactivity disorder (ADHD) Rating Scale-IV (K-ADHD-RS-IV)

  Before treatment, 4 and 11 weeks after treatment

• The Clinical Global Impression (CGI) rating scale

  Before treatment, 4 and 11 weeks after treatment

• The Frankfurt Attention Inventory (FAIR)

  Before treatment, 4 and 11 weeks after treatment

• Resting-state electroencephalogram (EEG)

  Before treatment, 4 and 11 weeks after treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

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

Interventions

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).

Experimental; Placebo

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biomix: lead
• Kyunghee University: collaborator

Study Sites (1)

Biomix

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

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Capsules

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Seung-Hun Cho, KMD., Ph.D.

  Kyunghee University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 20, 2018
• Study Start: November 1, 2011
• Primary Completion: April 30, 2013
• Study Completion: April 30, 2013
• Last Updated: February 23, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)