UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048679 |
|---|---|
| Receipt number | R000055470 |
| Scientific Title | Investigation of the effect of test food on the intestinal barrier |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/06/05 12:45:13 |
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Basic information
Public title
Investigation of the effect of test food on the intestinal barrier
Acronym
Investigation of the effect of test food on the intestinal barrier
Scientific Title
Investigation of the effect of test food on the intestinal barrier
Scientific Title:Acronym
Investigation of the effect of test food on the intestinal barrier
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of the test food consumed for 8 weeks on intestinal barrier index
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal barrier index
Key secondary outcomes
Blood/fecal tests
Subjective symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 8 weeks
Interventions/Control_2
Control (No treatment)
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Males and females aged more than or equal to 20, and less than 75 when obtaining the consent
2. Subjects whose BMI is 18.5 or more and less than 30
3. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the present study and being able to sign a written informed consent
Key exclusion criteria
1. Subjects who have been reported to have galactosemia
2. Subjects who have history of gastrointestinal surgical procedures
3. Subjects who take food or supplement which have the possibility to affect the results of the present study more than 4 days a week before 2 months of informed consent
4. Subjects who can't restrict food or supplement which have the possibility to affect the results of the present study from the observation period to the present study period
5. Subjects who take medications that may affect bowel symptoms or non-steroidal anti-inflammatory drugs such as aspirin more than 3 days a week before 1 months of informed consent
6. Subjects who have taken antibiotics before 2 months of informed consent
7. Subjects who can't restrict taking OTC drugs, quasi-drugs, supplements, or health foods from the day before the examination until the completion of the examination
8. Subjects who are expected to undergo a major change in their home, work, or other living environment during the research period
9. Subjects who are smokers
10. Subjects who have abdominal symptoms by ingesting dairy products
11. Subjects with food allergies
12. Subjects who are pregnant or lactating, or intending to become pregnant during the study
13. Subjects who had participated in other clinical trials within the past month
14. Subjects suffering from or undergoing treatment for diabetes, digestive diseases, heart disease, thyroid disease, adrenal disease, and other metabolic diseases
15. Subjects who tested positive for hepatitis B virus or hepatitis C virus in the screening
16. Subjects deemed unsuitable for the present study by the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joutou-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.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 | 04 | Month | 01 | 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 | 08 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 05 | 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 | 08 | Month | 16 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055470
