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

A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Sesame Oil Cake Extract on Improvement of Cognitive Function

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

Study Overview

• Status: Completed
• Conditions: Cognitive Function
• Intervention / Treatment: Dietary supplement: Sesame Oil Cake Extract; Dietary supplement: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of
    • Department of Psychiatry, Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sesame Oil Cake Extract; Sesame Oil Cake Extract 1.5 g/day for 12 weeks	Dietary supplement: Sesame Oil Cake Extract; Sesame Oil Cake Extract 1.5 g/day for 12 weeks.
PLACEBO_COMPARATOR: Placebo; placebo for 12 weeks	Dietary supplement: placebo; placebo for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of the Montreal Cognitive Assessment(MoCA-K)	The cognitive function evaluation using the Montreal Cognitive Assessment(MoCA-K) is a total of 8 items, and evaluates cognitive functions such as time / execution power, vocabulary, memory, attention, sentence, abstraction, delayed recall, and orientation. Time / execution power's total score is 5 points, vocabulary's total score is 3 points, attention's total score is 3 points, sentence's total score is 3 points, abstraction's total score is 2 points, delayed recall's total score is 5 points, orientation's total score is 6 points. It takes about 10 minutes to complete, and the total score is 30 points and total score make sum score. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point. It takes about 10 minutes to complete, and the score is 30 points. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point.	12 weeks
Changes of beta-amyloid	Beta-amyloid(pg/mL) was measured in baseline and 12 weeks.	12 weeks
Changes of Oxidation index(8-OHdG)	Oxidation index(8-OHdG)(ng/mL) was measured in baseline and 12 weeks.	12 weeks

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2017
• Primary Completion (ACTUAL): August 10, 2018
• Study Completion (ACTUAL): August 10, 2018

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (ACTUAL): February 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Cognitive Function; Sesam Esamesame Oil Cake
• Other Study ID Numbers: KH_CF_SE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No