UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032565 |
|---|---|
| Receipt number | R000037019 |
| Scientific Title | Effects of Dietary Intake of Broccoli Sprouts on Intestinal Microbiota and Defecation in Human Subjects -2nd Trial- |
| Date of disclosure of the study information | 2018/05/13 |
| Last modified on | 2019/11/12 12:17:34 |
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Basic information
Public title
Effects of Dietary Intake of Broccoli Sprouts on Intestinal Microbiota and Defecation in Human Subjects -2nd Trial-
Acronym
Effects of Broccli Sprouts on Human Intestinal Microbiota and Defecation -2nd Trial-
Scientific Title
Effects of Dietary Intake of Broccoli Sprouts on Intestinal Microbiota and Defecation in Human Subjects -2nd Trial-
Scientific Title:Acronym
Effects of Broccli Sprouts on Human Intestinal Microbiota and Defecation -2nd Trial-
Region
| Japan |
Condition
Condition
chronic functional constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of dietary intake of sulforaphane-rich broccoli sprouts on balance of intestinal mcirobiota and defecation in patients with chronic functional constipation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
composition of beneficial and pathogenic intestinal micribiota in stool sampleobtained at 4 weeks after intervention
Key secondary outcomes
constipation score
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
broccoli sprouts (20 g/day = sulforaphane 88 mg/day for 4 weeks)
Interventions/Control_2
alfalfa sprouts (20 g/day = sulforaphane 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
| Not applicable |
Gender
Female
Key inclusion criteria
female human subjects, who are basically healthy other than having chronic constipation, whose constipation score is greater than 2 points
Key exclusion criteria
1. Subjects who have organic diseases in gastrointestinal tracts.
2. Subjects who are regularily using drugs, which influence on defecation.
3. Subjects who are regularily taking foods, which influence on defecation
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinori Yanaka |
Organization
University of tsukuba
Division name
Faculty of Medicine, Hitachi Medical Education and Research Center
Zip code
Address
2-1-1 Johnan-cho, Hitachi-shi, Ibaraki-ken, 317-0077, Japan
TEL
0294-23-1111
ynk-aki@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akinori Yanaka |
Organization
University of Tsukuba
Division name
Faculty of Medicine, Hitachi Medical Education and Research Center
Zip code
Address
2-1-1 Johnan-cho, Hitachi-shi, Ibaraki-ken, 317-0077, Japan
TEL
0294-23-1111
Homepage URL
ynk-aki@md.tsukuba.ac.jp
Sponsor or person
Institute
Ministry of Education and Scinece
Institute
Department
Personal name
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
2017-85
Org. issuing International ID_1
Hitachi General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | 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
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
| 2018 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2019 | 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
| 2018 | Year | 05 | Month | 12 | Day |
Last modified on
| 2019 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037019
