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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018342
Receipt No. R000021221
Scientific Title Effects of oral consumption of sulforaphane precursor-rich broccoli supersprouts on serum levels of advanced glycation end products in humans
Date of disclosure of the study information 2015/07/17
Last modified on 2020/01/19

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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/ctr_e/ctr_view.cgi?recptno=R000021221

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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