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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027106
Receipt No. 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

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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
Email 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
Email y-nishizaki@tokai.ac.jp

Sponsor
Institute Tokai University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030936

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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