UMIN-CTR Clinical Trial

Basic information
Public title	A study evaluating the effect of sesame leaf powder on plasma Amyloid beta in the elderly aged 65 years and older
Acronym	A study evaluating the effect of sesame leaf powder on plasma Amyloid beta in the elderly aged 65 years and older
Scientific Title	Single-center, randomized, single-blind, placebo-controlled parallel group comparative study to evaluate the effects of sesame leaf powder on plasma Amyloid beta in the elderly over 65 years of age
Scientific Title:Acronym	Single-center, randomized, single-blind, placebo-controlled parallel group comparative study to evaluate the effects of sesame leaf powder on plasma Amyloid beta in the elderly over 65 years of age
Region	Japan

Condition
Condition	none
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the effect of sesame leaf powder on plasma Amyloid beta in the elderly aged 65 and over in comparison with placebo powder.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in plasma Amyloid beta before and after eating the test meal for 60 days
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Eat test food for 60 days
Interventions/Control_2	Eat placebo food for 60 days
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Person who are 65 years old or older at the time of obtaining consent 2. Person with written informed consent
Key exclusion criteria	1. Person who are participating in other clinical trialsat the time of obtaining consent 2. Person who the investigators judge to be inappropriate for participation in this research
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Johji Middle name Last name Yamahara
Organization	Sakamoto Yakusouen, LLC.
Division name	none
Zip code	520-0113
Address	5-15-15 Sakamoto, Otsu City, Shiga
TEL	03-5543-0302
Email	goma@cro-srd.co.jp

Public contact
Name of contact person	1st name Yukari Middle name Last name Ogawa
Organization	SRD Co., Ltd.
Division name	Clinical Research Department
Zip code	104-0032
Address	3-4-8 Hatchobori, Chuo-ku, Tokyo
TEL	03-5543-0302
Homepage URL
Email	goma@cro-srd.co.jp

Sponsor
Institute	Sakamoto Yakusouen, LLC.
Institute
Department

Funding Source
Organization	Sakamoto Yakusouen, LLC.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical corporation Mitsuyakai Kamige Ohashi Clinic Clinical Trial Review Committee
Address	1-49-6 Kawaharamachi, Maebashi City, Gunma Prefecture
Tel	027-237-2800
Email	xxxxxxx@xxxxxxxxx

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	12
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 09 Month 22 Day
Date of IRB	2021 Year 10 Month 12 Day
Anticipated trial start date	2021 Year 10 Month 19 Day
Last follow-up date	2022 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 18 Day
Last modified on	2022 Year 10 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052229