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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045671
Receipt No. R000052135
Scientific Title A clinical study to evaluate the safety of plant-extracts containing foods. (SME-2021-04-FOSHUS)
Date of disclosure of the study information 2021/10/06
Last modified on 2021/10/05

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Basic information
Public title A clinical study to evaluate the safety of plant-extracts containing foods. (SME-2021-04-FOSHUS)
Acronym A clinical study to evaluate the safety of plant-extracts containing foods.
Scientific Title A clinical study to evaluate the safety of plant-extracts containing foods. (SME-2021-04-FOSHUS)
Scientific Title:Acronym A clinical study to evaluate the safety of plant-extracts containing foods.
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of plant-extracts foods.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse reaction
Key secondary outcomes Adverse event
Laboratory test value, Physical examination result

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 Daily intake of test food for four weeks
Interventions/Control_2 Daily intake of control food for four weeks
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) Those who are -> 20 years old at the time of IC acquisition and <65 years old at the end of food intake
(2) Those who have submitted written informed consent after fully understanding the purpose and content of this study
Key exclusion criteria (1) Those with systolic blood pressure less than 90 mmHg at the start of ingestion
(2) Women who are/might be pregnant or lactating during the study
(3) Those who have taken >=200 mL whole blood or blood donation within 4 weeks before the start of the intake
(4) Men who have taken =>400 mL whole blood within 12 weeks before the start of intake
(5) Women who have taken =>400 mL whole blood within 16 weeks before the start of intake
(6) Men who have taken =>1,200 mL whole blood total (including the sampling of this study) within 12 months before the start of intake
(7) Women who have taken =>800 mL whole blood total (including the sampling of this study) within 12 months before the start of intake
(8) Those who are participating in other clinical study or planning to participate or participated within the past 4 weeks
(9) Those who meet any of the following:
(a) suffering from heart, liver, or kidney disease (including complications of other diseases)
(b) having a history of cardiovascular disease
(c) diabetes
(d) allergic or highly sensitive to the test food
(10) Those who are receiving any treatment at the time of screening
(11) Those who regularly use pharmaceuticals (including quasi-drugs), foods for specified health use, foods with functional claims or health foods
(12) Those who smoke an average of 21 or more cigarettes in a day
(13) Those who drink an average of more than 60 g of pure alcohol in a day
(14) Those who have an extremely irregular eating habit
(15) Shift workers or midnight shift workers
(16) Others who are judged inappropriate for participant by the investigators
Target sample size 48

Research contact person
Name of lead principal investigator
1st name Takao
Middle name
Last name Tanaka
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 Takao_Tanaka@suntory.co.jp

Public contact
Name of contact person
1st name Noriko
Middle name
Last name Sekiguchi
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
Homepage URL
Email N_Sekiguchi@suntory.co.jp

Sponsor
Institute SUNTORY MONOZUKURI EXPERT LIMITED
Institute
Department

Funding Source
Organization SUNTORY BEVARAGE & 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 Miura Clinic, Medical Corporation Kanonkai IRB
Address Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel 06-6135-5200
Email info@miura-cl.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 医療法人花音会みうらクリニック

Other administrative information
Date of disclosure of the study information
2021 Year 10 Month 06 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 Preinitiation
Date of protocol fixation
2021 Year 09 Month 30 Day
Date of IRB
2021 Year 09 Month 30 Day
Anticipated trial start date
2021 Year 10 Month 06 Day
Last follow-up date
2021 Year 12 Month 16 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 10 Month 05 Day
Last modified on
2021 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052135

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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