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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037518
Receipt No. 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 2019/11/26

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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
Email 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
Email Keisuke_Yasumoto@suntory.co.jp

Sponsor
Institute Suntory MONOZUKURI Expert Limited
Institute
Department

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
Email 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 No longer recruiting
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
2019 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042773

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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