UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055878 |
|---|---|
| Receipt number | R000063723 |
| Scientific Title | An Exploratory Study of the Effects of Consumption of A plant-derived food in Middle-aged and elderly women, including before and after menopause: A Randomized, Double-Blind, Parallel Group Study |
| Date of disclosure of the study information | 2024/10/22 |
| Last modified on | 2025/04/21 16:22:55 |
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Basic information
Public title
An Exploratory Study of the Effects of Consumption of A plant-derived food in Middle-aged and elderly women, including before and after menopause: A Randomized, Double-Blind, Parallel Group Study
Acronym
An Exploratory Study of the Effects of Consumption of A plant-derived food in Middle-aged and elderly women, including before and after menopause
Scientific Title
An Exploratory Study of the Effects of Consumption of A plant-derived food in Middle-aged and elderly women, including before and after menopause: A Randomized, Double-Blind, Parallel Group Study
Scientific Title:Acronym
An Exploratory Study of the Effects of Consumption of A plant-derived food in Middle-aged and elderly women, including before and after menopause
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of a plant-derived food reducing psychological stress reactions in daily life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Profile of Mood States 2nd Edition
TMD (Total Mood Disturbance) score,6 Mood scale
Key secondary outcomes
1. SMI (Simplified MenopausalIndex)
2. Visual Analogue Scale (Feeling of Fatigue)
3. OSA sleep inventory MA version
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of Test Food daily for
12 weeks
Interventions/Control_2
Intake of Placebo daily for
12 weeks
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
| 40 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Those who with temporary menopausal symptoms
2. Those who have obtained the prior consent of the individual through electronic consent
Key exclusion criteria
1. If you are undergoing treatment for menopausal symptoms
2. If you are undergoing treatment for any disease (including medication) at a medical institution
3. If you have a serious illness or a history of serious illness
4. If the subject habitually takes medicines, supplements, nutrient-fortified foods, or iron pills for the purpose of improving menopausal symptoms
5. Have a current or history of drug allergy or food allergy (those who are at risk of developing allergic symptoms to the Test food)
6. Those who have participated or are currently participating in other clinical trials within 1 month of obtaining consent, or those who are scheduled to participate during the study period.
7. Those who drink a lot of alcohol daily (60g alcohol equivalent/day)
8. Those who smoke
9. Those who work at night.
10. Those who are judged to be inappropriate as participants for this study by the research collaborate physician
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Faculty of Agriculture, Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
819-0395
Address
744 Motooka, Nishiku-Fukuoka City
TEL
092-802-4675
shimizu.kuniyoshi.381@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masumi |
| Middle name | |
| Last name | Nagae |
Organization
Faculty of Agriculture Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
815-8540
Address
Room 403, Open Design Laboratory Building 2 4-9-1, Shiobaru, Minami-ku Fukuoka City
TEL
092-553-9458
Homepage URL
sffps.hitoshiken@agr.kyushu-u.ac.jp
Sponsor or person
Institute
Faculty of Agriculture, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
SBS Incorporated
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
3G Science LLC
Name of secondary funder(s)
Kurume Research Park Co., Ltd., Fukuoka Bioindustry R&D Initiatives 2024
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee.
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1590
jimukyoku@mail.souken-r.com
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
| 2024 | Year | 10 | Month | 22 | 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
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
| 2024 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063723
