UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051359 |
|---|---|
| Receipt number | R000058352 |
| Scientific Title | A Study of the effects of a test-food on gut microenvironment connected with immunity |
| Date of disclosure of the study information | 2024/06/21 |
| Last modified on | 2023/06/16 14:28:14 |
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Basic information
Public title
A Study of the effects of a test-food on gut microenvironment connected with immunity
Acronym
A Study of the effects of a test-food on gut microenvironment connected with immunity
Scientific Title
A Study of the effects of a test-food on gut microenvironment connected with immunity
Scientific Title:Acronym
A Study of the effects of a test-food on gut microenvironment connected with immunity
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify some kind of effect by the test-food intakes for twelve weeks on gut microenvironment and immunity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total amount of short chain fatty acids in feces (total amount of acetic acid, propionic acid, and n-butyric acid)
Key secondary outcomes
1. Short chain fatty acids in feces (acetic acid, propionic acid, and n-butyric acid)
2. Intestinal flora
3. Organic acid in feces (lactic acid, succinic acid, iso-valeric acid, n-valeric acid, formic acid, iso-butyric acid)
4. Immunoglobulin-A in feces
5. Ammonia in feces
6. Spoiled products in feces
7. Water in feces
8. pH in feces
9. Activity of plasmacytoid dendritic cells (cluster of differentiation 123, blood-dendritic cell antigen 4, cluster of differentiation 86, human leukocyte antigen DR, cluster of differentiation 40, cluster of differentiation 80) in blood
10. Constipation assessment scale-mid term
11. 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
Parallel
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the test food to the subjects, two a day (at breakfast, lunch or dinner) for 12 weeks.
Interventions/Control_2
Ingestion of the placebo food to the subjects, two a day (at breakfast, lunch or dinner) for 12 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) Male/female subjects ranging in age from 20 to 64, at informed consent.
(2) Subjects who can take the test food two a day.
(3) Subjects who can receive the test foods twice a week.
(4) Subjects with defection frequency of no more than five times a week.
(5) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
Subjects - -
(1) taking in affecting foods (e.g., L. lactis strain Plasma) over 3 times a week,
(2) who have taken affecting medicines (e.g., antibiotic), within the last month before a pre-test,
(3) who take affecting medicine (e.g., anti-histamine, multi-ingredient cold medication) over twice a week,
(4) taking in a yogurt, probiotic beverage, dietary fiber-rich staple food (e.g., unpolished rice) over 3 times a week,
(5) who had undergone appendectomy,
(6) who have received the affecting surgery (e.g., colonoscopy) within half a year before the consent,
(7) who will vaccinate within the last month before and during this study,
(8) taking excessive alcohol,
(9) with extremely irregular life rhythms (e.g., midnight work),
(10) taking oral medication or medical diet,
(11) being under a low-carb diet,
(12) having below a meal a day (over a day a week), within the last month before a pre-test,
(13) who will change their life style, dietary habit, and living environment (e.g., move) during this study,
(14) being under another clinical test with a medicine or health food, or partook in that within 4 weeks before this study, or will partake in that after the consent,
(15) with over 30.0 kg/m2 of BMI,
(16) whose roomer is planning to partake in this study,
(17) with previous/current medical history of severe cardiac, hepatic, renal or digestive diseases,
(18) with pregnancy, possibly one, or lactating,
(19) having drug and food allergy (wheat, egg, milk and soybean),
(20) who donated their blood components or blood (0.2 L) within the last month,
(21) who donated his blood (0.4 L) within the last 3 months,
(22) who donated her blood (0.4 L) within the last 4 months,
(23) being collected in total of his blood (1.2 L) within the last 12 months and in this study,
(24) being collected in total of her blood (0.8 L) within the last 12 months and in this study,
(25) who have been determined as ineligible for participation, by the principal/sub doctor - - .
Target sample size
40
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-Cho, Chuo-ku, Tokyo 103-0021, Japan
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
| 2024 | Year | 06 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058352
