UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021207 |
|---|---|
| Receipt number | R000024456 |
| Scientific Title | Studies in the effects of dietary intake of broccoli sprouts on intestinal microflora and bowel movements in healthy human subjects. |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2018/05/12 21:22:36 |
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Basic information
Public title
Studies in the effects of dietary intake of broccoli sprouts on intestinal microflora and bowel movements in healthy human subjects.
Acronym
Effects of BS intake on human intestinal microflora
Scientific Title
Studies in the effects of dietary intake of broccoli sprouts on intestinal microflora and bowel movements in healthy human subjects.
Scientific Title:Acronym
Effects of BS intake on human intestinal microflora
Region
| Japan |
Condition
Condition
healthy human subjects with mild constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine if dietary intake of sulforaphane-rich broccoli sprouts changes intestinal miroflora, and improves constipation in humans.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Intestinal microflora at 4 weeks after starting intake of broccoli sprouts(BS), and at 4 weeks after finishing intale of BS.
Key secondary outcomes
Constipation Assessment Scale
Bristol Stool Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intervention Group (24 cases)
Broccoli Sprouts 20g/day for 4 weeks
(Sulforaphane Glucosinolate 88 mg/day)
Interventions/Control_2
Placebo Group (24 cases)
Alfalfa Sprouts 20g/day for 4 weeks
(Sulforaphane Glucosinolate 0 mg/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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy human subects without organic gastrointestinal diseases, and with mild constipation, whose constipation assessment score (CAS) is greater than 1.
Key exclusion criteria
Subjects
1) with organic gastrointestinal diseases
2) with allergy to broccoli or alfala
3) with taking any drugs, which affects intestinal microflora, and bowel movements
(e.g. NSAIDs, antibiotics,laxatives)
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yanaka, Akinori |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Hitachi Medical Education and Research Center
Zip code
Address
in Hitachi general hospital, 2-1-1 Jounan-cho, Hotachi-shi, Ibaraki-ken, 317-0077
TEL
0294-23-1111
ynk-aki@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yanaka, Akinori |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Hitachi Medical education and Research Center
Zip code
Address
in Hitachi general hospital, 2-1-1 Jounan-cho, Hotachi-shi, Ibaraki-ken, 317-0077
TEL
0294-23-1111
Homepage URL
ynk-aki@md.tsukuba.ac.jp
Sponsor or person
Institute
Univeristy of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Murakami Pharm, Inc
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
Address
Tel
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
| 2016 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 25 | Day |
Last modified on
| 2018 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024456
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
