UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044985 |
|---|---|
| Receipt number | R000051326 |
| Scientific Title | Efficacy trial of 4 weeks ingestion of MSHF001 food |
| Date of disclosure of the study information | 2021/07/30 |
| Last modified on | 2023/01/16 21:19:03 |
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Basic information
Public title
Efficacy trial of 4 weeks ingestion of MSHF001 food
Acronym
Efficacy trial of 4 weeks ingestion of MSHF001 food
Scientific Title
Efficacy trial of 4 weeks ingestion of MSHF001 food
Scientific Title:Acronym
Efficacy trial of 4 weeks ingestion of MSHF001 food
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of MSHF001 food ingestion effects on menopausal symptoms in healthy females.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of hot flashes
Key secondary outcomes
-Kupperman Kohnenki Shohgai Index (KKSI)
-Menopause Symptom Assessment form
-WHO QOL26
-WHO-5-J
-The Brief Job Stress Questionnaire English version (B)
-STAI
-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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of four MSHF001-containing tablets per day (two tablets each after breakfast and before bedtime) for four weeks.
Interventions/Control_2
Consumption of four placebo food tablets per day (two tablets each after breakfast and before bedtime) for four 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
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
-Healthy females
Healthy females with hot flashes
Key exclusion criteria
-Subjects who are hot flashes 7 times a day or more, or 50 times a week or more.
-Subjects with Kupperman index of 44 or higher.
-Subjects with systemic illness.
-Subjects who are diagnosed as menopausal disorders.
-Subjects who are under Hormone Replacement Therapy (HRT).
-Subjects who are outpatients or were treated by doctor within a month.
-Subjects who are antidepressants, anxiolytics, hypnotic sedatives, taking drugs that affect psychiatric symptoms.
-Subjects who have taken drugs or supplements (products mainly made with equol, isoflavones, and polyphenol-rich) that affect menopausal symptoms from 4 weeks before the screening trial.
-Subjects who have been taking drugs or prescription drugs that affect the trial since 4 weeks before the start of the screening trial.
-Subjects who are pregnant or lactating, or planned to become pregnant in the near future.
-Subjects with smoking habit.
-Subjects with drinking habit in every days (Alcohol equivalent 20g/day or more).
-Subjects who have significantly disrupted the rhythm of their lives during the study period.
-Subjects who have possibilities for emerging allergy to the ingredients contained in the test food, subjects with allergies such as drug allergy.
-Subjects who plan to participate in other surveys or clinical trials between the time of recruitment and the end of the trial.
-Subjects or their families engaged in the manufacture of health foods or supplements , market research company.
-Subjects judged not appropriate by the physician responsible for the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Misawa |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
31-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-7268
misawa.koichi@kao.com
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Ohtsuka |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
31-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-285-68-7236
Homepage URL
ohtsuka.mayumi@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.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
花王株式会社（栃木県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 30 | 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
| 2021 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 24 | 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 | 07 | Month | 28 | Day |
Last modified on
| 2023 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051326
