UMIN-CTR 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
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
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
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/ctr_e/ctr_view.cgi?recptno=R000041387
