UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate menopausal symptoms in middle-aged women.
Acronym	A study to evaluate menopausal symptoms in middle-aged women.
Scientific Title	A study to evaluate menopausal symptoms in middle-aged women.
Scientific Title:Acronym	A study to evaluate menopausal symptoms in middle-aged women.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate effects of a test food on the menopausal symptoms.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire for assessment of menopausal symptoms
Key secondary outcomes	Blood test value

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	Treatment
Type of intervention	Food
Interventions/Control_1	Daily intakes of a test food for 6 months
Interventions/Control_2	Daily intakes of a placebo food for 6 months
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	60 years-old >
Gender	Female
Key inclusion criteria	1. Japanese premenopausal women aged over 40 but less than 60. 2. Individuals who have no climacteric disorder and have several climacteric symptoms. 3. Individuals who have normal estrogen production. 4. Individuals who have a normal menstrual cycles. 5. Individuals who can write informed consent, and come to the designated venue for this study.
Key exclusion criteria	1. Individuals being patient or have a history of serious disease of liver, kidney, heart, thyroid, internal organs and diabetes. 2. Individuals who have a history of ovariectomy or hysterectomy, who are taking medications for menopausal symptoms. 3. Individuals who have internal medical chronic diseases. 4. Individuals who are constantly using medicines and functional health foods that promote menopausal symptoms. 5. Shift workers including late-night shift. 6. Individuals who are pregnant, breastfeeding, and wish to become pregnant during the test. 7. Individuals who have excessively smoking or alcohol drinking habits. 8. Individuals judged inappropriate for the trial by the principal.
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Susumu Middle name Last name Ishikawa
Organization	Medical Corporation Shoureikan Sinsapporo Seiryo hospital
Division name	Internal Medicine
Zip code	004-0004
Address	4-2-1-30, Atsubetsuhigashi, Atsubetsu-ku, Sapporo, Hokkaido
TEL	011-898-2151
Email	Ishikawa_seiryo@yahoo.co.jp

Public contact
Name of contact person	1st name Isao Middle name Last name Takehara
Organization	Clinical Support Corporation Co., Ltd.
Division name	PI-Food Service Division
Zip code	060-0061
Address	4-1, South 1 West 8, Chuo-ku, Sapporo, Hokkaido
TEL	011-223-3130
Homepage URL
Email	takehara@csc-smo.co.jp

Sponsor
Institute	Medical Corporation Shoureikan Sinsapporo Seiryo hospital
Institute
Department

Funding Source
Organization	Asahi Quality & Innovations, Ltd.
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	Institutional Review Board of the Medical Corporation Hokubukai Utsukushigaoka Hospital
Address	61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido
Tel	001-882-0111
Email	matsuda@ughp-cpc.jp

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	2020 Year 01 Month 31 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	106
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 10 Month 11 Day
Date of IRB	2019 Year 10 Month 07 Day
Anticipated trial start date	2020 Year 02 Month 28 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 08 Day
Last modified on	2022 Year 07 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044577