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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000047726 |
Receipt No. | R000054416 |
Scientific Title | Investigation of the effects of test-food intakes on gut environment |
Date of disclosure of the study information | 2022/05/11 |
Last modified on | 2022/05/11 |
Basic information | ||
Public title | Investigation of the effects of test-food intakes on gut environment | |
Acronym | Investigation of the effects of test-food intakes on gut environment | |
Scientific Title | Investigation of the effects of test-food intakes on gut environment | |
Scientific Title:Acronym | Investigation of the effects of test-food intakes on gut environment | |
Region |
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Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | In order to investigate some kind of effect on gut environment by the test-food ingestion for 4 weeks. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Fecal IgA level |
Key secondary outcomes | 1. Gut microbiota
2. Gut metabolites 3. Defecation status (the number of days, frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor) |
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 | Consumption of the test food (1 g per day) every day for 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 and Female | |||
Key inclusion criteria | (1) At informed consent, male/female subjects aged more than or equal to 20, and less than 80 years old.
(2) Subjects who can show understanding of the study procedures and agreement with participating in the study by written informed consent prior to the study. |
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Key exclusion criteria | (1) Subjects who have consumed cellobiose within the last 1 month to the study start, or have a plan to consume it during this study.
(2) Subjects who are regularly consuming foods for specified health uses, foods with function claims, supplements and/or health foods for more than 3 times a week, which would affect the study results. (3) Subjects who have current medical history/anamnesis of immune-related diseases such as autoimmune diseases or digestive ones. (4) Pregnant, possibly pregnant, or lactating women. (5) Subjects who have an allergy to the test food. (6) Subjects who have been determined ineligible for participation, judging from the principal investigator's opinions. |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Metagen, Inc. | ||||||
Division name | Headquarters | ||||||
Zip code | 997-0052 | ||||||
Address | 246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan | ||||||
TEL | +81-235-64-0330 | ||||||
research@metagen.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Metagen, Inc. | ||||||
Division name | Headquarters | ||||||
Zip code | 997-0052 | ||||||
Address | 246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan | ||||||
TEL | +81-235-64-0330 | ||||||
Homepage URL | |||||||
research@metagen.co.jp |
Sponsor | |
Institute | Metagen, Inc. |
Institute | |
Department |
Funding Source | |
Organization | KAKUI 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 of Chiyoda Paramedical Care Clini |
Address | 2F Daiwa Building, 3-3-10 Nihonbashihongoku-cho, Chuo-ku, Tokyo 103-0021, Japan |
Tel | +81-3-6225-9005 |
IRB@cpcc.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 | Preinitiation | ||||||
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 of closure to data entry | |||||||
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=R000054416 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |