Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function

Chonbuk National University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cognitive Function

Treatments: Dietary Supplement: Eriobotyra Japonica Lindley Extract; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01734200

INs-MF-ERIO

Details and patient eligibility

About

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on improvement of Memory Function. The investigators measured decrement of improvement of Memory Function, including K-MMSE, Rey-Kim Memory Test, BCRS, and PRMQ, and monitored their blood pressure.

Enrollment: 80 patients

Sex: All

Ages: 16 to 19 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males and females 16-19 years old
• Weight within ±30% of ideal body weight
• Able to give informed consent

Exclusion criteria

• Allergic or hypersensitive to any of the ingredients in the test products
• History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
• History of alcohol or substance abuse
• Participation in any other clinical trials within past 2 months
• Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
• Pregnant or lactating women etc.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Eriobotyra Japonica Lindley Extract

Experimental group

Treatment:

Dietary Supplement: Eriobotyra Japonica Lindley Extract

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo