UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045783 |
|---|---|
| Receipt number | R000052229 |
| 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 |
| Date of disclosure of the study information | 2021/10/18 |
| Last modified on | 2022/10/20 15:38:43 |
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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
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
goma@cro-srd.co.jp
Sponsor or person
Institute
Sakamoto Yakusouen, LLC.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052229
