UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027106 |
|---|---|
| Receipt number | R000030936 |
| Scientific Title | Study on health benefits of the broccoli Super Sprout |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2019/02/25 10:55:09 |
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Basic information
Public title
Study on health benefits of the broccoli Super Sprout
Acronym
Study on health benefits of the broccoli Super Sprout
Scientific Title
Study on health benefits of the broccoli Super Sprout
Scientific Title:Acronym
Study on health benefits of the broccoli Super Sprout
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of broccoli Super Sprout in terms of health promotion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
8-OHdG production rate
Key secondary outcomes
As secondary endpoints, following items will be evaluated: physical parameters, subjective scores of quality of life, Questions about subjective feelings of fatigue, glycometabolism, physical and mental stress, liver function, serum lipid
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Broccoli Super Sprout loading Group (12 cases): Broccoli Super Sprouts 20g/day for 5 days
Interventions/Control_2
Placebo Group (12 cases): Alfalfa 20g/day for 5 days
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Males and females who are 35 to 65 age.
2. Person who are not applicable on the following exclusion criteria.
3. Person who receive adequate explanation for participation in this research and provide written informed consent by their own free will.
Key exclusion criteria
We will exclude subjects
1. who are taking medicine regularly with some kind of diseases.
2. with viral hepatitis
3. with serious heart problems
4. with renal dysfunction (serum creatinine > 2.0 mg/dL)
5. with tumor bearing.
6. without capacity of self- management of proper intake and storage on test food.
7. with serious diseases in their life and then judged unsuitable for this study
8. with risk of allergy in associate with this study.
9. With suspected acute infectious diseases which have symptoms such as fever, sore throat, cough, diarrhea, vomiting etc.
10. who participated in other clinical trials within 2 months.
11. Who are taking medicines or supplement thought to affect this study.
12. Who ingested other cruciferous vegetables within 7 days before study day.
13. Who are judged unsuitable for this study by principal investigator and/ or sub-investigator at the collaborative research institution (Shinanozaka Clinic)
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Nishizaki |
Organization
Tokai University School of Medicine
Division name
Dept. of Clinical Health Science
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
TEL
0463-93-1121
y-nishizaki@tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Nishizaki |
Organization
Tokai University School of Medicine
Division name
Dept. of Clinical Health Science
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
TEL
0463-93-1121
Homepage URL
y-nishizaki@tokai.ac.jp
Sponsor or person
Institute
Tokai University
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
信濃坂クリニック（東京）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 01 | 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
| 2017 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 26 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 28 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 04 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 24 | Day |
Last modified on
| 2019 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030936
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
