Efficacy and Safety of Sesame Oil Cake Extract on Improvement of Cognitive Function

Chonbuk National University

Status

Completed

Conditions

Cognitive Function

Treatments

Dietary Supplement: placebo

Dietary Supplement: Sesame Oil Cake Extract

Study type

Interventional

Funder types

Other

Identifiers

NCT03826121

KH_CF_SE

Details and patient eligibility

About

This study was the efficacy and safety of Sesame oil cake extract on improvement of Cognitive Function

Full description

This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 70 subjects were participated in Sesame Oil Cake Extract or placebo group. To evaluate the changes of the evaluation items when Sesame Oil Cake Extract was taken three times a day compared with placebo.

Enrollment

70 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Those who are at least 60 years of age at screening
Those who word list memory / recollection/ recognition test scores of CERAD -K decrease 1-2 SD number of normal value
Those who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial

Exclusion criteria

Those with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years
Those with alcohol abuse or dependence within the last 3 months
Those who have clinically significant following severe illness (Epilepsy, mental retardation, brain nervous system diseases, endocrine diseases, blood / malignant tumors, cardiovascular diseases, Crohn's disease, etc.)
Those who shows the following results in the Laboratory test
- AST, ALT > 3 times upper limit of normal range
- Other significant laboratory test opinion
Those who take any prescription medicines or herbal medicines within 2 weeks before the first ingestion date or take any OTC or vitamin preparations within 1 week
Those who participate in other human trial within 2 months before the first ingestion
Those who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks
Those who is deemed unsuitable for participating in the human trial due to other reasons