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Completed

NCT Number: NCT03826121

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

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Key information

Conditions

Cognitive Function

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, Chonbuk National University Hospital

Jeonju, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sesame Oil Cake Extract

Dietary Supplement

Sesame Oil Cake Extract 1.5 g/day for 12 weeks.

Placebo

Dietary Supplement

placebo for 12 weeks.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2019
Registry last updated
Jul 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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