Clinical trial NCT03826121: Efficacy and Safety of Sesame Oil Cake Extract on Improvement of Cognitive Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Keywords: Cognitive Function
Sesam Esamesame Oil Cake
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes of Visual learning test
timeFrame: 12 weeks
measure: Changes of Visual working memory test
timeFrame: 12 weeks
measure: Changes of Verbal learning test
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes of the Montreal Cognitive Assessment(MoCA-K)
timeFrame: 12 weeks
measure: Changes of beta-amyloid
timeFrame: 12 weeks
measure: Changes of Oxidation index(8-OHdG)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Department of Psychiatry, Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Young-chul Chung, MD
role: PRINCIPAL_INVESTIGATOR
References: