UMIN-CTR Clinical Trial

Basic information
Public title	Safety evaluation of an excessive consumption of kiwifruit extract
Acronym	Safety evaluation of an excessive consumption of kiwifruit extract
Scientific Title	Safety evaluation of an excessive consumption of kiwifruit extract
Scientific Title:Acronym	Safety evaluation of an excessive consumption of kiwifruit extract
Region	Japan

Condition
Condition	Nothing (healthy subject)
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Safety evaluation of an excessive consumption of kiwifruit extract
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood biochemical test(0w, 6w, 12w)
Key secondary outcomes	Body measurement (0w, 6w, 12w) Hematologic test(0w, 6w, 12w) Urine analysis(0w, 6w, 12w) Doctor's questions(0w, 6w, 12w) Adverse events Questionnaires

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Kiwifruit extract 1,800 mg, 12weeks
Interventions/Control_2	Placebo, 12weeks
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese males and females 2. BMI>=18.5 and <25 kg/m2
Key exclusion criteria	1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who are patient or have history of cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Subjects who have undergone gastrointestinal tract surgery; except appendectomy 4. Subjects who are currently taking medicines (include herbal medicines) and/or supplements 5. Subjects who are allergic to medicines or the test material of this trial 6. Subjects who are or are possibly pregnant, or are lactating 7. Subjects who participate in other clinical trials in the past 3 months 8. Subjects who work time is irregular 9. Subjects who have a smoking habit 10. Subjects who have been determined ineligible by principal investigator for other reasons
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Yutaka Middle name Last name Kondo
Organization	Omnica Co.,Ltd
Division name	Research and development Dept.
Zip code	1120002
Address	TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5840-9815
Email	kondo@omnica.co.jp

Public contact
Name of contact person	1st name Junko Middle name Last name Hirota
Organization	Omnica Co.,Ltd
Division name	Research and development Dept.
Zip code	1120002
Address	TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5840-9815
Homepage URL
Email	hirota@omnica.co.jp

Sponsor
Institute	Omnica Co.,Ltd
Institute
Department

Funding Source
Organization	Omnica 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	Ginza Hospital
Address	KABUKIZA TOWER 16F, 4-12-15 Ginza, Chuo-ku, Tokyo
Tel	03-3542-2660
Email	j-noguchi@ginzahospital.com

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	医療法人財団 百葉の会 銀座医院(東京都)

Other administrative information
Date of disclosure of the study information	2018 Year 07 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	24
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	No longer recruiting
Date of protocol fixation	2018 Year 04 Month 27 Day
Date of IRB	2018 Year 04 Month 27 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2018 Year 11 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 05 Month 21 Day
Last modified on	2019 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037154