UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060310 |
|---|---|
| Receipt number | R000068990 |
| Scientific Title | Study on Improvement of Intestinal Environment and Defecation by Intake of beet (Randomized Crossover Trial) |
| Date of disclosure of the study information | 2026/01/09 |
| Last modified on | 2026/01/09 14:26:52 |
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Basic information
Public title
Study on Improvement of Intestinal Environment and Defecation by Intake of beet (Randomized Crossover Trial)
Acronym
Study on Improvement of Intestinal Environment and Defecation by Intake of beet (Randomized Crossover Trial)
Scientific Title
Study on Improvement of Intestinal Environment and Defecation by Intake of beet (Randomized Crossover Trial)
Scientific Title:Acronym
Study on Improvement of Intestinal Environment and Defecation by Intake of beet (Randomized Crossover Trial)
Region
| Japan |
Condition
Condition
Healthy adult men and women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct a randomized crossover trial to examine the effect of beetroot powder intake on bowel movements associated with changes in intestinal bacteria in healthy adult men and women.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Intestinal microbiota analysis (conducted twice: once during the test food intake period and once during the control food intake period)
2.Stool record (recorded daily during the study period, over a total of 11 weeks : a one-week observation period, a four-week test food intake period, a two-week rest period, and a four-week control food intake period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1.Test period is 11 weeks.
2.Observation period(1 week)->Test food intake period(4 weeks)->Washout period(2 weeks)->Placebo food intake period(4 weeks)
3.Test food contained beet powder.
Interventions/Control_2
1.Test period is 11 weeks.
2.Observation period(1 week)->Placebo food intake period(4 weeks)->Washout period(2 weeks)->Test food intake period(4 weeks)
3.Test food contained beet powder.
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
| 18 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy adult men and women
2.Subjects who have 3 to 5 bowel movements per week or those who have difficulty defecating or a feeling of incomplete bowel movements
Key exclusion criteria
1.Subjects with a history of digestive disorders or gastrointestinal surgery
2.Subjects who regularly use intestinal regulators or laxatives (including laxatives)
3.Subjects who are unable to stop excessive intake of foods containing live bacteria such as lactic acid bacteria, bifidobacteria, and natto bacteria, including 'Food for Specified Health Uses' and 'Foods with Functional Claims', during the study period
4.Subjects who are pregnant or willing to be pregnant or breast-feeding during this study
5.Subjects who are allergic to nuts (almonds)
Target sample size
20
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
| 2026 | Year | 01 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2026 | Year | 01 | Month | 09 | Day |
Last modified on
| 2026 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068990
