UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032657 |
|---|---|
| Receipt number | R000037154 |
| Scientific Title | Safety evaluation of an excessive consumption of kiwifruit extract |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2019/06/28 09:42:05 |
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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
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
hirota@omnica.co.jp
Sponsor or person
Institute
Omnica Co.,Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037154
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
