UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047742 |
|---|---|
| Receipt number | 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 | 2022/11/11 15:36:16 |
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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
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
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
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
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
Completed
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 | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054425
