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

NCT ID: NCT03826121

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2018-08-10

Brief Summary

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

Detailed 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.

Conditions

Cognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Sesame Oil Cake Extract

Sesame Oil Cake Extract 1.5 g/day for 12 weeks

Group Type: EXPERIMENTAL

Sesame Oil Cake Extract

Intervention Type: DIETARY_SUPPLEMENT

Sesame Oil Cake Extract 1.5 g/day for 12 weeks.

Placebo

placebo for 12 weeks

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

placebo for 12 weeks.

Interventions

Sesame Oil Cake Extract

Sesame Oil Cake Extract 1.5 g/day for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

placebo

placebo for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chonbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Young Chul Chung

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Young-chul Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

Department of Psychiatry, Chonbuk National University Hospital

Jeonju, , South Korea

Countries

South Korea

Other Identifiers

KH_CF_SE

Identifier Type: -

Identifier Source: org_study_id