UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045431 |
|---|---|
| Receipt number | R000051842 |
| Scientific Title | A Clinical Study for Evaluating the Safety of Long-Term Consumption and Excessive Consumption of Food Containing Plant Extract -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- |
| Date of disclosure of the study information | 2021/09/09 |
| Last modified on | 2022/03/14 12:24:40 |
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Basic information
Public title
A Clinical Study for Evaluating the Safety of Long-Term Consumption and Excessive Consumption of Food Containing Plant Extract
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym
A Clinical Study for Evaluating the Safety of Long-Term Consumption and Excessive Consumption of Food Containing Plant Extract
Scientific Title
A Clinical Study for Evaluating the Safety of Long-Term Consumption and Excessive Consumption of Food Containing Plant Extract
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym
A Clinical Study for Evaluating the Safety of Long-Term Consumption and Excessive Consumption of Food Containing Plant Extract
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of long-term consumption and excessive consumption of food containing plant extract
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Doctor's questions, Physical measurement, Physical examination, Blood test (Hematological test, Blood biochemical test), Urinalysis, Adverse event
Key secondary outcomes
Questionnaire
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
Food containing plant extract,
12 weeks consumption,
4 weeks excessive consumption
Interventions/Control_2
Food not containing plant extract,
12 weeks consumption,
4 weeks excessive consumption
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females aged 20 to 64 years-old.
(2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1) Subjects who were diagnosed with serious disease (e.g., diabetes, liver disease, kidney disease, digestive disease, heart disease, respiratory disease and/or peripheral vascular disease).
(2) Subjects with abnormal parameters in liver and/or kidney function.
(3) Subjects who had a gastrointestinal surgery.
(4) Subjects with a disease currently under treatment.
(5) Subjects with drug or food allergies.
(6) Subjects with anemic.
(7) Subjects who play high intensity sports and/or are on a diet.
(8) Subjects with irregular life patterns.
(9) Subjects who can't stop using functional foods (including Food for Specified Health Uses or Foods with Function Claims) and/or Specified quasi-drugs during the current study periods.
(10) Subjects who are under treatment with medications (including OTC and/or prescribed medications).
(11) Subjects who drink excessive alcohol.
(12) Subjects who can't stop drinking from one day before each measurement.
(13) Subjects who are pregnant, planning to become pregnant or lactating during the current study period.
(14) Subjects who are participating in other studies or planning to participate at the start of the current study.
(15) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal Medicine
Zip code
530-0044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
06-6135-5200
mterashima@miula.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness support Co., Ltd.
Division name
Clinical trial Division
Zip code
530-0044
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Oneness support Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel
06-6135-5200
mterashima@miula.co.jp
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 09 | 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
| 2021 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 09 | Day |
Last modified on
| 2022 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051842
