UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048374 |
|---|---|
| Receipt number | R000055134 |
| Scientific Title | Evaluation of the effects of test food intakes on the intestinal environment |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2023/06/30 11:02:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the effects of test food intakes on the intestinal environment
Acronym
Evaluation of the effects of test food intakes on the intestinal environment
Scientific Title
Evaluation of the effects of test food intakes on the intestinal environment
Scientific Title:Acronym
Evaluation of the effects of test food intakes on the intestinal environment
Region
| Japan |
Condition
Condition
Healthy male/female subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of the test food intakes on intestinal environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Intestinal metabolites
Key secondary outcomes
Intestinal microbiota
Defecation status (days of defecation, frequency of defecation, volume of defecation, stool consistency, stool color, feeling of residual stool during defecation, abdominal pain during defecation, odor)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingesting a whole bag of juice A (200ml) per day within 30 minutes.
Interventions/Control_2
Ingesting a whole bag of juice B (200ml) per day within 30 minutes.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Men and women aged between 20 and 80 at the time of obtaining consent
(2) Persons who have been fully informed about the test, understand its content and are able to give their written consent
Key exclusion criteria
(1) Persons who cannot agree the prohibition of intake of juice made of vegetables and fruits during the study period (from obtaining consent to the end-up of follow-up testing).
(2) Persons who consume foods for specified health uses, functional foods, health foods, yoghurt or probiotic drinks at least three times a week, which may affect the test.
(3) Persons with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc.
(4) Pregnant, lactating or intending to become pregnant during the study period
(5) Persons who has allergies to testing food.
(6) Persons who has present history of the disease.
(7) Persons who are deemed by the study investigator or sub-investigator to be unsuitable to participate in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Murakami |
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
| 1st name | Ryo |
| Middle name | |
| Last name | Hattori |
Organization
Kakugin Corporation
Division name
Corporate Planning Department
Zip code
997-0034
Address
1-4-23, Hon-Cho, Tsuruoka, Yamagata, Japan
TEL
+81-235-22-2202
Homepage URL
ryo_h@kakugin.com
Sponsor or person
Institute
Metagen, Inc.
Institute
Department
Personal name
Funding Source
Organization
Kakugin Corporation
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 Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo
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
| 2022 | Year | 07 | Month | 20 | 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 | 06 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | 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 | 07 | Month | 14 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055134
