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

Biomix

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Dietary Supplement: Standardized Lycium chinense Fruit Extract (LCF) capsules

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03439111

KOMCGIRB-2013-88

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 14 to 24 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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75 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Standardized Lycium chinense Fruit Extract (LCF) capsules

Experimental

Experimental group

Description:

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

Treatment:

Dietary Supplement: Standardized Lycium chinense Fruit Extract (LCF) capsules