UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026285 |
|---|---|
| Receipt number | R000030145 |
| Scientific Title | A Study to Evaluate the Safety of Long Term Consumption of Food Containing Plant Extract. |
| Date of disclosure of the study information | 2017/02/26 |
| Last modified on | 2021/02/17 15:52:06 |
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Basic information
Public title
A Study to Evaluate the Safety of Long Term Consumption of Food Containing Plant Extract.
Acronym
A Study to Evaluate the Safety of Long Term Consumption of Food Containing Plant Extract.
Scientific Title
A Study to Evaluate the Safety of Long Term Consumption of Food Containing Plant Extract.
Scientific Title:Acronym
A Study to Evaluate the Safety of Long Term Consumption of Food Containing Plant Extract.
Region
| Japan |
Condition
Condition
Healthy Adult (including borderline diabetes)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of long term consumption of food containing plant extract for 12 weeks in healthy adults.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inquiry, physical examination, medical examination by hematology,blood biochemistry, urinalysis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food containing plant extract, 12 weeks consumption.
Interventions/Control_2
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) 20<=Age=<64 of healty men and women
(2) Subjects who are judged as normoglycemic or borderline diabetes by the investigator
(3) Subjects who can make self-judgments and voluntarily give written informed consents
Key exclusion criteria
(1) Subjects with a medical history of diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, or severe diseases
(2) Subjects with a disorder in heart and lung function
(3) Subjects with abnormal parameters in liver or kidney function
(4) Subjects who had a gastrointestinal surgery
(5) Subjects with a disease currently under treatment
(6) Subjects with drug or food allergies
(7) Subjects with anemic
(8) Subjects who play high intensity sports or are on a diet
(9) Subjects who are taking supplemental foods, quasi drugs or drug products (including OTC or prescribed medication) containing ingredient of test food
(10) Subjects who drink excessive alcohol, or who cannot stop drinking alcohol at one day prior to the test day and the day of the test
(11) Subjects who have been pregnant or subjects who have a plan to become pregnant or breast feed during the study period
(12) Subjects who is participating in other studies or planning to participate during the study period
(13) Subjects who are deemed unsuitable by the investigator for other reasons
Target sample size
15
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
tterashima@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
tterashima@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
| 2017 | Year | 02 | Month | 26 | 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 | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 24 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030145
