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

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ClinicalTrials.gov Identifier: NCT03826121
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Young Chul Chung, Chonbuk National University Hospital

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

Condition or disease Intervention/treatment Phase
Cognitive Function Dietary Supplement: Sesame Oil Cake Extract Dietary Supplement: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Estimated Study Start Date : February 20, 2019
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sesame oil

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.




Primary Outcome Measures :
  1. Changes of Visual learning test [ Time Frame: 12 weeks ]
    Visual learning test was measured in baseline and 12 weeks.

  2. Changes of Visual working memory test [ Time Frame: 12 weeks ]
    Visual working memory test was measured in baseline and 12 weeks.

  3. Changes of Verbal learning test [ Time Frame: 12 weeks ]
    Verbal learning test was measured in baseline and 12 weeks.


Secondary Outcome Measures :
  1. Changes of the Montreal Cognitive Assessment(MoCA-K) [ Time Frame: 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.


  2. Changes of beta-amyloid [ Time Frame: 12 weeks ]
    Beta-amyloid(pg/mL) was measured in baseline and 12 weeks.

  3. Changes of Oxidation index(8-OHdG) [ Time Frame: 12 weeks ]
    Oxidation index(8-OHdG)(ng/mL) was measured in baseline and 12 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826121


Contacts
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Contact: Young-chul Chung, MD 82 63 250 2185 chungyc@jbnu.ac.kr

Locations
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Korea, Republic of
Department of Psychiatry, Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of
Contact: Lee Na Kim    82 10 7112 1894      
Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
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Principal Investigator: Young-chul Chung, MD Chonbuk National University Hospital

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Responsible Party: Young Chul Chung, Professor of Psychiatry, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT03826121     History of Changes
Other Study ID Numbers: KH_CF_SE
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Young Chul Chung, Chonbuk National University Hospital:
Cognitive Function
Sesam Esamesame Oil Cake