UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063178 |
|---|---|
| Receipt number | R000072298 |
| Scientific Title | Effect of Dietary Intake of Sulforaphane-Rich Broccoli Sprouts on Colonization of Butyrate-Producing Gut Microbiota, and Butyrate Level in Stool Samples from Human Healthy Subjects. |
| Date of disclosure of the study information | 2026/10/05 |
| Last modified on | 2026/10/05 15:40:42 |
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Basic information
Public title
Effect of Broccoli Sprouts on Intestinal Microbiota and Butyrate Production in Human Healthy Subjects.
Acronym
Broccoli Sprouts and Intestinal Microbiota
Scientific Title
Effect of Dietary Intake of Sulforaphane-Rich Broccoli Sprouts on Colonization of Butyrate-Producing Gut Microbiota, and Butyrate Level in Stool Samples from Human Healthy Subjects.
Scientific Title:Acronym
Broccoli Sprouts and Butyrate-Producing Microbiota
Region
| Japan |
Condition
Condition
Helathy Colon
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of dietary approach with sulforaphane-rich broccoli sprouts on butyrate-producing bacteria and butyrate level in colonic luminal environment in human healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Butyrate concentration in stool samples from human healthy subjects
Key secondary outcomes
Composition of butyrate-producing microbiota in stool samples from human healthy subjects
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Dietary intake of Broccoli Sprouts 50g (220 mg)/day for 4 weeks
Interventions/Control_2
Dietary intake of Alfalfa Sprouts 50g (0 mg)/day for 4 weeks
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy Subjects with age between 20 and 70
2) Subjects who agree to participate in the study with written informed consent
Key exclusion criteria
Healthy Subjects,
1) who have past or present history of organic intestinal diseases, such as inflammatory bowel diseases and colon tumors.
2) who regularly or ocasionaly take medical drugs or supplements, which may affect composition of intestinal microbiota, such as probiotics, prebiotics, NSAIDs, acid Inhibitors, antibiotics.
2-b) who occasionally, at least more than once, takes medical drugs, which may affect composition of intestinal microbiota, such as probiotics, prebiotics, NSAIDs, Acid Inhibitors, Antibiotics.
3) who did not agree to participate in this study with written informed consent
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Yanaka |
Organization
Tsukuba Gakuen Hospital
Division name
Department of Gastroenterology
Zip code
305-0854
Address
2573-1, Kamiyokoba, Tsukuba-shi, Ibaraki-ken, 305-0854, Japan
TEL
029-836-1366
yanaka.akinori.mw@alumni.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Yanaka |
Organization
Tsukuba Gakuen Hospital
Division name
Department of Gastroenterology
Zip code
305-0854
Address
2573-1, Kamiyokoba, Tsukuba-shi, Ibaraki-ken, 305-0854, Japan
TEL
029-836-1355
Homepage URL
yanaka.akinori.mw@alumni.tsukuba.ac.jp
Sponsor or person
Institute
Tsukuba Gakuen Hospital
Institute
Department
Personal name
Akinori YAnaka
Funding Source
Organization
Murakami Farm Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Gakuen Hospital
Address
2573-1, Kamiyokoba, Tsukuba-shi, Ibaraki-ken, 305-0854, Japan
Tel
029-836-1355
yanaka.akinori.mw@alumni.tsukuba.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 | 10 | Month | 05 | 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 | 04 | Month | 08 | Day |
Date of IRB
| 2005 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 24 | 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 | 10 | Month | 05 | Day |
Last modified on
| 2026 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072298
