UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038166 |
|---|---|
| Receipt number | R000043466 |
| Scientific Title | Safety confirmation test of overdose intake of foods containing Camellia Japonica seed extract -open-label trial- |
| Date of disclosure of the study information | 2019/10/04 |
| Last modified on | 2020/04/02 10:13:47 |
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Basic information
Public title
Safety confirmation test of overdose intake of foods containing Camellia Japonica seed extract
Acronym
Safety confirmation test of overdose intake of foods containing Camellia Japonica seed extract
Scientific Title
Safety confirmation test of overdose intake of foods containing Camellia Japonica seed extract -open-label trial-
Scientific Title:Acronym
Safety confirmation test of overdose intake of foods containing Camellia Japonica seed extract -open-label trial-
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the safety of excessive the test foods to consume 5 times of normal daily intake for 4 weeks in healthy Japanese subjects.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body measurement, physical examination
Hematology test
Blood biochemistry test
Urinalysis
Doctor's questions
Assess these at screening (before intake), at 2 and 4 weeks after intake.
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
Intake of test foods for 4 consecutive weeks (10 capsules/ day)
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) Healthy adult males and females between 20 to 64 years
(2) BMI: less than 30 kg/m2
(3) Subjects who have received sufficient explanation about the purpose and content of the examination, have the ability to consent, have a good understanding, volunteered to participate and agreed to participate in the examination in writing
Key exclusion criteria
(1) Subjects who were diagnosed with liver disease, kidney disease, gastrointestinal disease, heart disease, diabetes, or other diseases that may affect the results of this study, or who have a history of surgery
(2) Subjects who indicate abnormal parameter in liver or kidney function
(3) Subjects with a disease currently under treatment
(4) Subjects with anemia
(5) Subjects who detect abnormal values by blood test
(6) Subjects who determine ineligible by principal investigator
(7) Subjects with drug or food allergies
(8) Subjects who play high intensity sports and/or are on a diet
(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 or prescribed medication)
(11) Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement
(12) Subjects with smoking habit
(13) Subjects with irregular life patterns and lifestyle of reversal of day and night
(14) Subjects who have a habit of excessive eating and drinking
(15) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period
(16) Subjects who is participating in the other study or planning to participate during the study period
(17) Subjects who has taken the blood sampling more than 200 mL within 1 month, or plan the blood sampling during the study period
Target sample size
20
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
9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
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
4F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
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
BHN 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
Miura Clinic, Medical Corporation Kanonkai IRB
Address
9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
Tel
06-6135-5200
mterashima@oneness-sup.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
| 2019 | Year | 10 | Month | 04 | 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
| 2019 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 01 | Day |
Last modified on
| 2020 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043466
