UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy trial of ingestion of the development code MSHFS001.
Acronym	Efficacy trial of ingestion of the development code MSHFS001.
Scientific Title	Efficacy trial of ingestion of the development code MSHFS001.
Scientific Title:Acronym	Efficacy trial of ingestion of the development code MSHFS001.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Obsterics and gynecology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the development code MSHFS001 efficacy on menopausal symptoms and so on, in healthy females.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy of the 4 weeks ingestion of the development code MSHFS001 on menopausal symptoms 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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Daily ingestion of six MSHFS001 tablets before bedtime for 4 weeks.
Interventions/Control_2	Daily ingestion of six placebo tablets before bedtime for 4 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 -Subjects whose Kupperman Kohnenki Shohgai Index (KKSI) are more than medium degree, or below medium degree on a case by case basis. -Subjects who have the symptoms of hot flushes.
Key exclusion criteria	-Subjects who have been suffered from disease. -Subjects who regularly take medicine. -Subjects who are undergoing medical treatment or were treated by doctor within a month. -Subjects who are under hormone replacement therapy (HRT), and / or subjects who are in medication that affect blood hormone levels. -Subjects who regularly take supplements related to menopausal symptoms. -Subjects who regularly take functional food and/or supplements related to sleep. -Subjects who are pregnant, lactating, or planned to become pregnant during the test period. -Subjects with smoking habit. -Subjects who cannot follow the restriction of eating habit. -Subjects who have possibilities for emerging allergy to foods, metals, and drugs. -Subjects who are shift workers. -Subjects deemed inappropriate to participate in this study by the principle investigator.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Kiyoshi Middle name Last name Kataoka
Organization	Kao Corporation
Division name	Health Care Food Research
Zip code	131-8501
Address	2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL	+81-3-5630-9877
Email	kataoka.kiyoshi@kao.com

Public contact
Name of contact person	1st name Yuka Middle name Last name Enokuchi
Organization	Kao Corporation
Division name	Health Care Food Research
Zip code	131-8501
Address	2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL	+81-3-5630-9877
Homepage URL
Email	enokuchi.yuka@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	+81-3-5630-9220
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（東京都） 株式会社リサーチ・アンド・ディベロプメント（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 13 Day

Related information
URL releasing protocol	https://www.mdpi.com/2072-6643/12/12/3757
Publication of results	Published

Result
URL related to results and publications	https://www.mdpi.com/2072-6643/12/12/3757
Number of participants that the trial has enrolled	82
Results	The results show that continuous intake of CGAs resulted in improvements in menopausal symptoms, especially hot flushes, in healthy women.
Results date posted	2020 Year 12 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The inclusion criteria for the subjects were as follows: healthy women 40 to 59 years of age, moderate or severe rating according to the modified Kupperman menopausal index (mKMI) severity grading (including a moderate or a lower score in some cases), and subjective symptoms of hot flushes. The exclusion criteria were as follows: those affected by disease; taking regular medication; receiving regular outpatient treatment at a medical facility or visited a hospital within one month prior to the pre-examination; taking HRT; taking medication that may interfere with hormones; regularly taking supplements that affect menopausal symptoms; regularly taking functional foods and supplements that have been shown to be effective in improving sleep; pregnant, breastfeeding, or willing to become pregnant during the study period; smokers; unable to follow the dietary restrictions during the study period; known to have a past or current history of allergies; leading irregular lifestyles; or deemed unfit for enrollment by the physician in charge or by the principal investigator due to other causes.
Participant flow	https://www.mdpi.com/2072-6643/12/12/3757
Adverse events	None
Outcome measures	https://www.mdpi.com/2072-6643/12/12/3757
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 08 Month 23 Day
Date of IRB	2018 Year 08 Month 23 Day
Anticipated trial start date	2018 Year 09 Month 18 Day
Last follow-up date	2018 Year 12 Month 06 Day
Date of closure to data entry	2019 Year 04 Month 24 Day
Date trial data considered complete	2019 Year 04 Month 24 Day
Date analysis concluded	2019 Year 11 Month 26 Day

Other
Other related information

Management information
Registered date	2018 Year 09 Month 06 Day
Last modified on	2020 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038818