UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000036481
Receipt number R000041387
Scientific Title Effects of whole grain soybean beverage on equol production ability, pre- or post-menstrual disorder syndrome symptoms (physiological and mental symptoms)
Date of disclosure of the study information 2019/04/13
Last modified on 2020/12/19 13:19:19

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041387


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name