UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037518 |
|---|---|
| Receipt number | R000042773 |
| Scientific Title | A study of excessive intake of the food containing plant-derived ingredient. (SME-2019-02-FOSHUS) |
| Date of disclosure of the study information | 2019/07/29 |
| Last modified on | 2020/11/05 10:23:01 |
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Basic information
Public title
A study of excessive intake of the food containing plant-derived ingredient.
(SME-2019-02-FOSHUS)
Acronym
A study of excessive intake of the food containing plant-derived ingredient.
Scientific Title
A study of excessive intake of the food containing plant-derived ingredient.
(SME-2019-02-FOSHUS)
Scientific Title:Acronym
A study of excessive intake of the food containing plant-derived ingredient.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of food
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expression rate of side effects
Key secondary outcomes
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
Four weeks repeated intake of the test foods
Interventions/Control_2
Four weeks repeated intake of the control foods
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Healthy male and female whose age are 20 <= years old <65.
(2)Subjects who are able to visit
medical institution on the stipulated date.
(3)Subjects who are able to submit the written informed consents.
Key exclusion criteria
(1) Subjects who are with treatment.
(2) Subjects whose systolic pressure <90 mmHg.
(3) Females in pregnancy,lactation and scheduled pregnancy period.
(4) Subjects who donated over 200ml blood components or whole blood within 4 weeks.
(5) Male Subjects who donated over 400ml whole blood within 12 weeks.
(6) Female who donated over 400ml whole blood within 16 weeks.
(7) Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added.
(8) Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added.
(9) Subjects who are participating in other clinical studies, or who finished clinical study within 4 weeks.
(10) Subjects who are;
(a)With present heart disorder,liver disorder,or kidney disorder.
(b)With history of cardiac disorder.
(c)With diabetes mellitus.
(d)With allergy to drugs or foods.
(e)With glaucoma.
(f)With hyponatremia.
(11) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results.
(12) Subjects who drink alcohol or smoke a lot.
(13) Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift.
(14) Subjects who themselves or family living together work at a company that plans, researches, develops, manufactures or sells supplements and/or functional foods (including Food for Specified Health Uses).
(15) Subjects who are deemed to be unsuitable by the investigator.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Obata |
Organization
Suntory MONOZUKURI Expert Limited
Division name
R&D Support Department, HE Center
Zip code
135-8631
Address
2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL
03-5579-1277
Hidenori_Obata@suntory.co.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Yasumoto |
Organization
Suntory MONOZUKURI Expert Limited
Division name
R&D Support Department, HE Center
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
0774-66-1110
Homepage URL
Keisuke_Yasumoto@suntory.co.jp
Sponsor or person
Institute
Suntory MONOZUKURI Expert Limited
Institute
Department
Personal name
Funding Source
Organization
Suntory Beverage & Food Limited
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
Institutional Review Board of Takara Clinic
Address
2-3-2 Higashigotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
info@takara-clinic.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 29 | 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 | 07 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 15 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2020 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042773
