UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy trial of 4 weeks ingestion of the development code MSHF001 food
Acronym	Efficacy trial of 4 weeks ingestion of the development code MSHF001 food
Scientific Title	Efficacy trial of 4 weeks ingestion of the development code MSHF001 food
Scientific Title:Acronym	Efficacy trial of 4 weeks ingestion of the development code 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 (development code) food ingestion effects on general malaise in healthy females.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of 4 weeks ingestion of the development code MSHF001 food effects of on general malaise and so on.
Key secondary outcomes

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	5
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	In healthy females aged 40 to 59 years with subjective symptoms of hot flash, daily ingestion of two MSHF001(development code) food tablets twice a day, after breakfast meals and at bed time for 4 weeks.
Interventions/Control_2	In healthy females aged 40 to 59 years with subjective symptoms of hot flash, daily ingestion of two placebo food tablets twice a day, after breakfast meals and at bed time for 4 weeks.
Interventions/Control_3	In healthy females aged 40 to 59 years without subjective symptoms of hot flash, daily ingestion of two MSHF001 (development code) food Tablets twice a day, after breakfast meals and at bed time for 4 weeks.
Interventions/Control_4	In healthy females aged 40 to 59 years without subjective symptoms of hot flash, daily ingestion of two placebo food Tablets twice a day, after breakfast meals and at bed time for 4 weeks.
Interventions/Control_5	In healthy females aged 20 to 35 years, no intervention. Performing only one measurement.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	59 years-old >=
Gender	Female
Key inclusion criteria	-Healthy females 1.Subjects at climacteric period who have the symptoms of hot flushes. 2.Subjects at climacteric period who have the symptoms of hot flushes. 3.Subjects between ages 20 and 35 who have stable menstrual cycle.
Key exclusion criteria	-Subjects with systemic illness. -Subjects who are diagnosed as menopausal disorders. -Subjects who are under Hormone Replacement Therapy, HRT, and/or medication which would affect blood hormone levels. -Subjects who are outpatients or were treated by doctor within a month. -Subjects who regularly take medicine. -Subjects who regularly take medicines that affect menopausal symptoms. -Subjects who are pregnant or lactating, or planned to become pregnant in the near future. -Subjects with smoking habit. -Subjects with drinking habit in 5 or more days a week. -Subjects who have possibilities for emerging allergy to foods, metals, and drugs. -Subjects with illnesses or diseases on their face, especially such as atopic dermatitis, or psoriasis, or severe acne. -Subjects who habitually having specific polyphenol-rich health food and drink. -Subjects with high anxiety questionnaire values. -Subjects with high Kupperman Kohnenki Shohgai Index. -Subjects who easily have skin rashes. -Subjects with potential conflict of interest.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Yamamoto
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7538
Email	yamamoto.naoki@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	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7538
Homepage URL
Email	ohtsuka.mayumi@kao.com

Sponsor
Institute	Kao Corporation
Institute
Department

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
Email	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） 株式会社 リサーチ・アンド・ディベロプメント（東京）

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 13 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	100
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	2019 Year 12 Month 04 Day
Date of IRB	2019 Year 12 Month 04 Day
Anticipated trial start date	2019 Year 12 Month 13 Day
Last follow-up date	2020 Year 04 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 12 Month 13 Day
Last modified on	2021 Year 04 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044299