UMIN-CTR Clinical Trial

Basic information
Public title	Effects of oral consumption of sulforaphane precursor-rich broccoli supersprouts on serum levels of advanced glycation end products in humans
Acronym	Effects of oral consumption of sulforaphane precursor-rich broccoli supersprouts on serum levels of advanced glycation end products in humans
Scientific Title	Effects of oral consumption of sulforaphane precursor-rich broccoli supersprouts on serum levels of advanced glycation end products in humans
Scientific Title:Acronym	Effects of oral consumption of sulforaphane precursor-rich broccoli supersprouts on serum levels of advanced glycation end products in humans
Region	Japan

Condition
Condition	healthy humans
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine whether oral consumption of sulforaphane precursor-rich broccoli supersprouts could decrease serum levels of advanced glycation end products in humans
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum AGE level Questionary on consciousness of eating healthy food
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral consumption of sulforaphane precursor-rich broccoli supersprouts
Interventions/Control_2
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 humans
Key exclusion criteria	1) allergy against food 2) subjects with cancer 3) subjects with severe liver disease (AST or ALT >100 U/L) 4) subjects with a history of cardiovascular disease 5) subjects with renal dysfunction 6) pregnant women 7) subjects with acute illness or infection 8) subjects with serum K>5mEq/L
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Sho-ichi Middle name Last name Yamagishi
Organization	Kurume University School of Medicine
Division name	Dept of Pathophysiology and Therapeutics of Diabetic Vascular Complications
Zip code	830-0011
Address	67 Asahi-machi, Kurume City
TEL	0942-31-7873
Email	shoichi@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Sho-ichi Middle name Last name Yamagishi
Organization	Kurume University School of Medicine
Division name	Dept of Pathophysiology and Therapeutics of Diabetic Vascular Complications
Zip code	830-0011
Address	67 Asahi-machi, Kurume City
TEL	0942-31-7873
Homepage URL
Email	shoichi@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University School of Medicine
Institute
Department

Funding Source
Organization	Kurume University School of Medicine Dept of Pathophysiology and Therapeutics of Diabetic Vascular Complications
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nishi Clinic
Address	Hara 3-8-23, Sawara-ku, Fukuoka, Japan
Tel	0928316181
Email	shoichi@med.kurume-u.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	2015 Year 07 Month 17 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	2015 Year 03 Month 01 Day
Date of IRB	2015 Year 03 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 17 Day
Last follow-up date	2015 Year 04 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 17 Day
Last modified on	2020 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021221