UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052450 |
|---|---|
| Receipt number | R000059842 |
| Scientific Title | Effects of test food intake on bowel movements and intestinal environment in healthy subjects |
| Date of disclosure of the study information | 2023/10/13 |
| Last modified on | 2024/11/13 09:43:09 |
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Basic information
Public title
Effects of test food intake on bowel movements and intestinal environment in healthy subjects
Acronym
Effects of test food intake on bowel movements and intestinal environment in healthy subjects
Scientific Title
Effects of test food intake on bowel movements and intestinal environment in healthy subjects
Scientific Title:Acronym
Effects of test food intake on bowel movements and intestinal environment in healthy subjects
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 4 weeks of continuous intake of the test food on bowel movements and intestinal environment in Japanese men and women aged 20 to 65 years old.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel diary
Key secondary outcomes
Stool test,POMS2,Food frequency questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
4-weeks intake of the test food A
Interventions/Control_2
4-weeks intake of the test food B
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. Japanese male and female subjects between the ages of 20 and 65 at the time of written consent.
2. Subjects who defecate 3 to 5 times per week.
3. Subjects who do not eat enough fiber in usual dietary life.
4. Subjects who have received a full explanation of the purpose and content of the study, have the ability to consent, understand the study well, and have volunteered to participate in the study and have agreed to participate in the study in writing.
Key exclusion criteria
1. Subjects who are currently receiving medication or outpatient treatment for some serious disease.
2. Subjects who are currently undergoing exercise or diet therapy under the supervision of a physician.
3. Subjects who may develop allergies to the test food.
4. Subjects who have a current or a history of drug dependence or alcohol dependence.
5. Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past.
6. Subjects who have irregular rhythm of life due to night work or shift work.
7. Subjects who are with extremely irregular eating, sleeping, or other habits.
8. Subjects who have an extremely unbalanced diet.
9. Subjects who have or have had serious diseases such as brain diseases, malignant tumors, immune diseases, diabetes, liver diseases (hepatitis), kidney diseases, heart diseases, etc., thyroid diseases, adrenal diseases, and other metabolic diseases.
10. Subjects who have undergone digestive organ (stomach, liver, gallbladder, pancreas, colon, etc.) surgery within the past year
11. Subjects with (suspected) chronic or acute infections.
12. Subjects who use health foods,supplements, and medicines that contain ingredients that affect bowel movements and the intestinal environment.
13. Subjects who have participated in other clinical trials (research) within 3 months retrospectively from the date of obtaining consent, or those who have plans to participate in other clinical trials (research) during the study period.
14. Subjects who have donated more than 200 mL of blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent.
15. Subjects who are currently pregnant or breastfeeding. or who are likely to become so during the study period.
16. Subjects who have difficulty in complying with the recording of various questionnaires.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
M&I Science CORP.
Division name
Clinical Development Department
Zip code
531-0071
Address
NAKATSUGRAND Bld.10F, 1-17-26, Nakatsu, Kita-ku, Osaka-Shi, Osaka, Japan
TEL
06-7878-6780
m.matsuoka@mis21.co.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
M&I Science CORP.
Division name
Clinical Development Department
Zip code
531-0071
Address
NAKATSUGRAND Bld.10F, 1-17-26, Nakatsu, Kita-ku, Osaka-Shi, Osaka, Japan
TEL
06-7878-6780
Homepage URL
m.matsuoka@mis21.co.jp
Sponsor or person
Institute
M&I Science CORP.
Institute
Department
Personal name
Funding Source
Organization
Japan Frito-Lay, 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
Miyake Clinic Institutional Review Board
Address
4-2-17 Komagome, Toshima-ku, Tokyo 170-0003 Japan
Tel
03-6903-7211
jim@medipharma.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 | 10 | Month | 13 | 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
44
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
| 2023 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 22 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 29 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 19 | Day |
Other
Other related information
(Exclusion criteria continued)
17. Subjects who are judged to be inappropriate as subjects based on clinical laboratory test values and measured values at the time of secondary SCR.
18. Others who are judged by the investigator to be inappropriate as subjects.
Management information
Registered date
| 2023 | Year | 10 | Month | 10 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059842
