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

NCT03826121 | Completed

• 1 other identifier: KH_CF_SE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognitive Function

Keywords

Cognitive Function; Sesam Esamesame Oil Cake

Outcome Measures

Primary Outcomes (3)

• Changes of Visual learning test

  Visual learning test was measured in baseline and 12 weeks.

  12 weeks

• Changes of Visual working memory test

  Visual working memory test was measured in baseline and 12 weeks.

  12 weeks

• Changes of Verbal learning test

  Verbal learning test was measured in baseline and 12 weeks.

  12 weeks

Secondary Outcomes (3)

• Changes of the Montreal Cognitive Assessment(MoCA-K)

  12 weeks

• Changes of beta-amyloid

  12 weeks

• Changes of Oxidation index(8-OHdG)

  12 weeks

Study Arms (2)

Sesame Oil Cake Extract

EXPERIMENTAL

Sesame Oil Cake Extract 1.5 g/day for 12 weeks

Dietary Supplement: Sesame Oil Cake Extract

Placebo

PLACEBO COMPARATOR

placebo for 12 weeks

Dietary Supplement: placebo

Interventions

Sesame Oil Cake Extract DIETARY_SUPPLEMENT

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

Sesame Oil Cake Extract

placebo DIETARY_SUPPLEMENT

placebo for 12 weeks.

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Department of Psychiatry, Chonbuk National University Hospital

Jeonju, South Korea

Location

Study Officials

• Young-chul Chung, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 1, 2019
• Study Start: September 15, 2017
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: July 25, 2019

Record last verified: 2019-07

Locations

KR (1)