UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Studies in the effects of dietary intake of broccoli sprouts on intestinal microflora and bowel movements in healthy human subjects.
Title of the study (Brief title)	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	Yanaka, Akinori
Organization	Faculty of Medicine, University of Tsukuba
Division name	Hitachi Medical Education and Research Center
Address	in Hitachi general hospital, 2-1-1 Jounan-cho, Hotachi-shi, Ibaraki-ken, 317-0077
TEL	0294-23-1111
Email	ynk-aki@md.tsukuba.ac.jp

Public contact
Name of contact person	Yanaka, Akinori
Organization	Faculty of Medicine, University of Tsukuba
Division name	Hitachi Medical education and Research Center
Address	in Hitachi general hospital, 2-1-1 Jounan-cho, Hotachi-shi, Ibaraki-ken, 317-0077
TEL	0294-23-1111
Homepage URL
Email	ynk-aki@md.tsukuba.ac.jp

Sponsor
Institute	Univeristy of Tsukuba
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024456