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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | None | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |