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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034313
Receipt No. R000039110
Scientific Title A verification study of safety evaluation of excessive consumption of the test food to consume 5 times more than regular daily intake in healthy subjects: an open-label trial
Date of disclosure of the study information 2018/09/28
Last modified on 2019/02/08

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Basic information
Public title A verification study of safety evaluation of excessive consumption of the test food to consume 5 times more than regular daily intake in healthy subjects: an open-label trial
Acronym A verification study of safety evaluation of excessive the test food consumption in humans
Scientific Title A verification study of safety evaluation of excessive consumption of the test food to consume 5 times more than regular daily intake in healthy subjects: an open-label trial
Scientific Title:Acronym A verification study of safety evaluation of excessive the test food consumption in humans
Region
Japan

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

Objectives
Narrative objectives1 To identify the safety of excessive the test food to consume 5 times more than regular daily intake for 4 weeks in healthy Japanese subjects
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Physical examination
2. Urinalysis
3. Blood test
4. Subjective symptoms (the Likert scale)

* Assess these at screening (before consumption), at 2 and 4 weeks after consumption, and follow-up period for 2 weeks
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 Duration: 4 weeks
Test food: Manda Koso STANDARD or Manda Koso GINGER
Dose: Take 5 packs per day
Administration: Take 5 packs with water or lukewarm water after breakfast

* If you forget to take the test food, take it as soon as you remember within the 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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Healthy Japanese adult subjects

2. Subjects who are judged as eligible to participate in the study by the physician
Key exclusion criteria 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily

5. Subjects who are currently taking medications (including herbal medicines) and supplement (including health food)

6. Subjects who are an allergic reaction to medications and/or the test food related products (particularly oranges, walnuts, sesame seeds, soybeans, bananas, and apples)

7. Subjects who are pregnant, breast-feeding, or planning to become pregnant

8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trials during trial period.

9. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization MANDA FERMENTATION CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 28 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
2018 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2018 Year 09 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
2018 Year 09 Month 28 Day
Last modified on
2019 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039110

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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