UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on health benefits of the broccoli Super Sprout
Title of the study (Brief title)	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	Yasuhiro Nishizaki
Organization	Tokai University School of Medicine
Division name	Dept. of Clinical Health Science
Address	143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
TEL	0463-93-1121
Email	y-nishizaki@tokai.ac.jp

Public contact
Name of contact person	Yasuhiro Nishizaki
Organization	Tokai University School of Medicine
Division name	Dept. of Clinical Health Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030936