UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018342 |
|---|---|
| Receipt number | 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 09:25:38 |
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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
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
shoichi@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
