UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048674 |
|---|---|
| Receipt number | R000055424 |
| Scientific Title | A Study of the effects of a test-food on gut microenvironment |
| Date of disclosure of the study information | 2023/08/19 |
| Last modified on | 2023/08/21 12:50:48 |
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Basic information
Public title
A Study of the effects of a test-food on gut microenvironment
Acronym
A Study of the effects of a test-food on gut microenvironment
Scientific Title
A Study of the effects of a test-food on gut microenvironment
Scientific Title:Acronym
A Study of the effects of a test-food on gut microenvironment
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to validate some kind of effect by the test-food intakes for four weeks on gut microenvironment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal flora (next generation-targeted amplicon sequencing analysis)
Key secondary outcomes
1. Defecation status (the number of days, frequency, quantity, property, color, fecal odor, feeling of incomplete evacuation, abdominal pain)
2. In stool: short chain fatty acids, ammonia, spoiled products, pH and water
3. In saliva: cortisol, cortisol corrected by protein, alpha-amylase, and alpha-amylase corrected by protein
4. In blood: miRNA
5. Constipation assessment scale-mid term
6. Visual Analog Scale (stress, fatigue, the feeling at waking up this morning, concentration)
7. Clinical test value
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food, one a day for 4 weeks.
Interventions/Control_2
Consumption of the placebo food, one a day for 4 weeks.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy male/female subjects ranging in age from 20 to 64, at informed consent.
(2) Subjects who can take one meal of the test food per day.
(3) Subjects who can receive the test foods once a week
(4) Subjects who defecate three to five times a week.
(5) Subjects who can give informed consent, after being provided with an explanation of the protocol detail.
Key exclusion criteria
Subjects-
(1) regularly taking affecting (intestinal regulation) food for specified health use, functional foods, health foods (including supplements), yogurt, or lactic acid bacteria beverages not less than 3 times a week.
(2) taking or will take in affecting medicines (antibiotic/gut/laxative regulation) within the last month before the advance inspection and during this study.
(3) planning to vaccinate from advance inspection to the end of this study.
(4) with history of appendix removal.
(5) who have received the affecting surgery (e.g. colonoscopy, removal of gallstones an d/or gall bladder, or gastric bypass surgery) within half a year before the consent.
(6) with excessive alcohol intake.
(7) with extremely irregular dietary habits.
(8) restricting their mealtimes to no more than once a day (not less than once a week), within the last month.
(9) planning to change their life style, dietary habit and Living environment (relocation, transfer).
(10) being under other clinical test of medicine and/or health food, or join within the last 4 weeks, or will join after the consent.
(11) whose housemate is planning to join this study.
(12) with previous/current medical history of serious diseases (severe cardiac, hepatic, renal or digestive diseases, etc).
(13) with pregnancy, possibly one, or lactating.
(14) with drug/food (especially wheat, eggs, or milk) allergy.
(15) who donated their blood components or blood (0.2 L) within the last month.
(16) who donated his blood (0.4 L) within the last 3 months.
(17) who donated her blood (0.4 L) within the last 4 months.
(18) being collected in total of his blood (1.2 L) within the last 12 months and in this study.
(19) being collected in total of her blood (0.8 L) within the last 12 months and in this study.
(20) being determined as ineligible for participation, judging from the principal.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Nisshin Seifun Group Inc.
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
Tel
03-6225-9005
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
| 2023 | Year | 08 | Month | 19 | 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
24
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 | 08 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 19 | 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 | 08 | Month | 16 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055424
