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

Not Applicable

Completed

• Conditions: Cognitive Function
• Interventions: Dietary Supplement: Sesame Oil Cake Extract; Dietary Supplement: placebo

• Registration Number: NCT03826121
• Lead Sponsor: Chonbuk National University Hospital

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.

Study Timeline

• Study Start: 2017-09-15
• Primary Completion: 2018-08-10
• Study Completion: 2018-08-10
• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sesame Oil Cake Extract	Sesame Oil Cake Extract	Sesame Oil Cake Extract 1.5 g/day for 12 weeks
Placebo	placebo	placebo for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes of Visual learning test	12 weeks	Visual learning test was measured in baseline and 12 weeks.
Changes of Visual working memory test	12 weeks	Visual working memory test was measured in baseline and 12 weeks.
Changes of Verbal learning test	12 weeks	Verbal learning test was measured in baseline and 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Changes of the Montreal Cognitive Assessment(MoCA-K)	12 weeks	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.
Changes of beta-amyloid	12 weeks	Beta-amyloid(pg/mL) was measured in baseline and 12 weeks.
Changes of Oxidation index(8-OHdG)	12 weeks	Oxidation index(8-OHdG)(ng/mL) was measured in baseline and 12 weeks.

Trial Locations

Locations (1)

Department of Psychiatry, Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of