UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058329 |
|---|---|
| Receipt number | R000066682 |
| Scientific Title | Study on Improvement of Intestinal Environment and Defecation by Intake of beet 2025 |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/07/01 08:49:32 |
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Basic information
Public title
Study on Improvement of Intestinal Environment and Defecation by Intake of beet 2025
Acronym
Study on Improvement of Intestinal Environment and Defecation by Intake of beet 2025
Scientific Title
Study on Improvement of Intestinal Environment and Defecation by Intake of beet 2025
Scientific Title:Acronym
Study on Improvement of Intestinal Environment and Defecation by Intake of beet 2025
Region
| Japan |
Condition
Condition
Healthy young women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effects of the intake of beet on the defecation status of healthy young women in relation to changes in intestinal bacteria.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal microflora analysis (conducted three times, once before and twice after ingestion of test product)
Stool record (recorded daily during the study period, including four week before and after the intake period)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Beet group
Test period is 10 weeks.
Four weeks before and after intake and 6 weeks after intake
One teaspoon (4 g) per day
Interventions/Control_2
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
| 19 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) A healthy young women
(2) Persons who understand the research description and give their consent by their own signature.
Key exclusion criteria
(1) Persons who varies menstrual cycle by more than 7 days.
(2) Those who has a medical history of diseases or surgery affecting digestion, absorption and bowel movement.
(3) Persons who cannot restrict the use of medicines, health foods, foods for specified health uses, foods with functional claims, health supplements, supplements, etc. that may affect bowel movements, and foods that contain a large amount of lactic acid bacteria.
(4) Persons who is pregnant or willing to be pregnant or breast-feeding during this study.
(5) Persons who have reached menopause.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mihoko |
| Middle name | |
| Last name | Moto |
Organization
Wayo Women's University
Division name
Department of Health and Nutrition
Zip code
272-8533
Address
2-3-1 konodai, Ichikawa, Chiba, Japan
TEL
047-371-2393
moto@wayo.ac.jp
Public contact
Name of contact person
| 1st name | Mihoko |
| Middle name | |
| Last name | Moto |
Organization
Wayo Women's University
Division name
Department of Health and Nutrition
Zip code
272-8533
Address
2-3-1 konodai, Ichikawa, Chiba, Japan
TEL
047-371-2393
Homepage URL
moto@wayo.ac.jp
Sponsor or person
Institute
Wayo Women's University
Institute
Department
Personal name
Funding Source
Organization
Wayo Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wayo Women's University Research Support Division
Address
2-3-1 konodai, Ichikawa, Chiba, Japan
Tel
047-371-1184
k-shien@wayo.ac.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
| 2025 | Year | 07 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 01 | Day |
Last modified on
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066682
