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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047742
Receipt No. R000054425
Scientific Title Verification of the effects of test foods on the intestinal environment
Date of disclosure of the study information 2022/05/12
Last modified on 2022/05/17

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Basic information
Public title Verification of the effects of test foods on the intestinal environment
Acronym Verification of the effects of test foods on the intestinal environment
Scientific Title Verification of the effects of test foods on the intestinal environment
Scientific Title:Acronym Verification of the effects of test foods on the intestinal environment
Region
Japan Asia(except Japan)

Condition
Condition None
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To obtain data on the improvement of the intestinal environment through the consumption of the test food for 4 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bifidobacteria, good bacteria
Key secondary outcomes Other intestinal environment data

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 Oral intake of test food (4 weeks)
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
60 years-old >
Gender Male
Key inclusion criteria 1) Healthy Japanese males whose age is between 20 and 60 years old.
2) No gastrointestinal disease. 2) No gastrointestinal disease, and not taking any medication during treatment.
3) BMI between 20 kg/m2 and 30 kg/m2.
4) Subjects who are aware that their intestinal environment is not good, such as constipation.
5) The subjects must have received a full explanation of the purpose and content of the study and must have signed a consent form prior to the start of the study.
Key exclusion criteria 1) Those with a history or current condition (disease) of liver disease, renal disease, cerebrovascular disease, diabetes, dyslipidemia, hypertension, or other chronic disease
2) Persons who are currently undergoing treatment for a serious illness.
3) Persons with food allergies or those who are at risk of developing allergies related to the tested food
4) Who are regularly using medicines or quasi-drugs that may affect the test items.
5) Persons who regularly use health foods (food for specified health use, nutritional supplements, functional foods, supplements, etc.) that may affect the test items.
6) Persons who are unable to discontinue the intake of pharmaceuticals (excluding intravenous medication), quasi-drugs, or health foods (food for specified health uses, nutritional supplements, foods with functional claims, supplements, etc.) from the time of obtaining consent to the completion of the study.
7) Persons who are unable to restrict or discontinue foods (including alcohol) that affect the data
8) Who are currently participating in a clinical trial or have participated in another clinical trial within the past 3 months from the date of obtaining consent
9) Who plan to participate in other clinical trials during the study period
10) Who are unable to maintain their daily lifestyle.
11) Who have difficulty consuming the study food as directed
12) Other subjects who are judged by the investigator to be unsuitable for the study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Ikuko
Middle name
Last name Sagara
Organization Well Aging Medical Corporation D Clinic Tokyo Wellness
Division name department of internal medicine
Zip code 100-0005
Address 1-11-1 Marunouchi, Chiyoda-ku, Tokyo Pacific Century Place Marunouchi 10F
TEL 03-6665-0502
Email plantanikuko@gmail.com

Public contact
Name of contact person
1st name Masako
Middle name
Last name Mizuuchi
Organization APO PLUS STATION CO., LTD.
Division name Clinical Operations Department, CRO Division
Zip code 103-0027
Address 2-14-1 Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
TEL 03-6386-8809
Homepage URL
Email food-contact@apoplus.co.jp

Sponsor
Institute APO PLUS STATION CO., LTD.
Institute
Department

Funding Source
Organization ANGFA 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 Institutional Review Board,Medical Corporation Ouryokukai Nihonbashi Sakura Clinic
Address 1-9-2,Nihonbashikayabacho,Chuo-ku,Tokyo,Japan
Tel 03-6661-9061
Email c-irb_ug@neues.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
2022 Year 05 Month 12 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 Open public recruiting
Date of protocol fixation
2022 Year 04 Month 26 Day
Date of IRB
2022 Year 04 Month 26 Day
Anticipated trial start date
2022 Year 05 Month 13 Day
Last follow-up date
2022 Year 07 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 12 Day
Last modified on
2022 Year 05 Month 17 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054425

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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