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

Cognitive Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826121
• Other study ID #: KH_CF_SE
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: August 10, 2018

Study information

• Verified date: July 2019
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 10, 2018
• Est. primary completion date: August 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function

Intervention

Dietary Supplement:
• Sesame Oil Cake Extract
Sesame Oil Cake Extract 1.5 g/day for 12 weeks.
• placebo
placebo for 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Department of Psychiatry, Chonbuk National University Hospital	Jeonju

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Visual learning test	Visual learning test was measured in baseline and 12 weeks.	12 weeks
Primary	Changes of Visual working memory test	Visual working memory test was measured in baseline and 12 weeks.	12 weeks
Primary	Changes of Verbal learning test	Verbal learning test was measured in baseline and 12 weeks.	12 weeks
Secondary	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
Secondary	Changes of beta-amyloid	Beta-amyloid(pg/mL) was measured in baseline and 12 weeks.	12 weeks
Secondary	Changes of Oxidation index(8-OHdG)	Oxidation index(8-OHdG)(ng/mL) was measured in baseline and 12 weeks.	12 weeks