UMIN-CTR Clinical Trial

Basic information
Public title	Effects of whole grain soybean beverage on equol production ability, pre- or post-menstrual disorder syndrome symptoms (physiological and mental symptoms)
Acronym	Whole grain soybean beverage intake trial
Scientific Title	Effects of whole grain soybean beverage on equol production ability, pre- or post-menstrual disorder syndrome symptoms (physiological and mental symptoms)
Scientific Title:Acronym	Whole grain soybean beverage intake trial
Region	Japan

Condition
Condition	Target population is young healthy women with menstrual and premenstrual disorder without g gynecological treatment.
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Long-term whole grain soybean beverage (WGS) intake will be performed to soybean products eating habit free population. WGS is expected to improve menstrual and premenstrual disorder through intestinal microbial flora change.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	-The comparison of equol in urine between initial and final samples after 12 weeks intake. -Improvement of menstrual and premenstrual major disorder during intake.
Key secondary outcomes	1) Time course study of equol content in urine. 2) Questionnaires on menstrual and premenstrual disorder (physical or mental aspects). 3) Relation of Microbialflora in intestine to 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	NO
Dynamic allocation	YES
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Whole grain soybean milk, total energy 88 kcal/portion -12 week intervention -Administration, one portion (125 mL) per day
Interventions/Control_2	Milk protein and coco-oil substituted soybean free 'soybean-like' beverage (88 kcal/portion) -12 week intervention -Administration, one portion (125 mL) per day
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	20 years-old <=
Age-upper limit	25 years-old >
Gender	Female
Key inclusion criteria	-Healthy women with the frequency of soybean-products consumption less than twice a week -The equol content in urine less than 5.0 micro-mol/g creatinine at isoflavone loading test
Key exclusion criteria	-Allergy for soybean and/or milk -Gly m4 type Oral allergy -Pregnant women -Patients receiving treatment for chronic diseases -Women disqualified by a physician in charge -Subjects who receiving medical treatment by Dysmenorrhea or premenstrual syndrome
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hadjime Middle name Last name NAKAJIMA
Organization	Wayo Women's University
Division name	Human Ecology Department, Graduate School
Zip code	272-0827
Address	Kohnodai 2-3-1, Ichikawa, Chiba
TEL	047-371-2367
Email	h-nakajima@wayo.ac.jp

Public contact
Name of contact person	1st name Hadjime Middle name Last name NAKAJIMA
Organization	Wayo Women's University
Division name	Human Ecology Department, Graduate School
Zip code	272-0827
Address	Kohnodai 2-3-1, Ichikawa, Chiba
TEL	047-371-2367
Homepage URL
Email	h-nakajima@wayo.ac.jp

Sponsor
Institute	Human Ecology Department, Graduate School of Wayo Women's University
Institute
Department

Funding Source
Organization	Otsuka Foods Company, Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	Biwako Research Institute, Otsuka Foods Company, Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics committee of medical and health research involving human subjects, Wayo Women's University
Address	Kohnodai 2-3-1, Ichikawa, Chiba, 272-0827
Tel	047-371-1184
Email	k-shien@wayo.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	1847
Org. issuing International ID_1	Ethics committee of medical and health research involving human subjects, Wayo Women's University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	和洋女子大学大学院総合生活研究科(Human Ecology Department, Graduate School of Wayo Women’s University)

Other administrative information
Date of disclosure of the study information	2019 Year 04 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	38
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 12 Month 31 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2019 Year 04 Month 10 Day
Date of IRB	2019 Year 03 Month 23 Day
Anticipated trial start date	2019 Year 04 Month 10 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 05 Month 31 Day
Date analysis concluded	2020 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date	2019 Year 04 Month 12 Day
Last modified on	2020 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041387