UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052997 |
|---|---|
| Receipt number | R000060455 |
| Scientific Title | Effects of consumption of the test food on bowel movement in healthy Japanese: a randomized, placebo-controlled, double-blind, crossover comparison study |
| Date of disclosure of the study information | 2023/12/04 |
| Last modified on | 2024/12/12 10:42:04 |
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Basic information
Public title
Effects of consumption of the test food on bowel movement in healthy Japanese
Acronym
Effects of consumption of the test food on bowel movement in healthy Japanese
Scientific Title
Effects of consumption of the test food on bowel movement in healthy Japanese: a randomized, placebo-controlled, double-blind, crossover comparison study
Scientific Title:Acronym
Effects of consumption of the test food on bowel movement in healthy Japanese
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to verify the effects of consuming the test food for two weeks on defecation status, subjectivity during bowel movements, and health-related quality of life in healthy Japanese men or women aged 20 or more and less than 65.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Defecation frequency and number of days with defecation
Key secondary outcomes
1. Amount of defecation, original questionnaire about bowel movement measured by visual analogue scale (VAS), health-related quality of life, stool shape, stool color, stool smell, and exhilarating feeling of defecation
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
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food for two weeks
Washout (Two weeks)
Consumption of the placebo food for two weeks
Interventions/Control_2
Consumption of the placebo food for two weeks
Washout (Two weeks)
Consumption of the test food for two 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. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals aged 20 or more and less than 65 at the time of agreement to participate in this study
6. Individuals who defecate three to five times per week at screening period
7. Individuals who eat three meals per day with a mealtime variation of less than two hours throughout the week.
8. Individuals whose BMI is less than 30 kg/m2
Key exclusion criteria
Individuals (who)
1. under treatment for malignancy, heart failure, and myocardial infarct/with a medical history of them
2. have a pacemaker/an implantable cardioverter defibrillator
3. under treatment for chronic diseases
4. take "Foods for Specified Health Uses"/"Foods with Functional Claims"/medications/herbal medicines/supplements (may affect the study) and cannot avoid taking during the study
5. are at risk of developing an allergy to the test food's ingredients
6. are pregnant/lactating/planning to become pregnant during the study
7. have diseases that may substantially affect bowel movement
8. enrolled in other studies within 28 days before agreeing to participate/plan to participate another study during the study
9. are judged as ineligible to participate by the physician
10. are smokers/quit smoking within a year before agreeing to participate
11. drink >=60-g/day of alcohol
12. are planning to relocate (for work/education)/events with unusual stress/living with family members who plan them
13. live with infants or care recipients
14. sleep with children aged 1~6 years or with care recipients
15. plan an unusual overnight stay during the study
16. are restricted to go to the restroom
17. have extremely irregular lifestyle habits
18. are judged as ineligible to participate from clinical measurements at screening
19. exercise for >=30 min at least twice a week to maintain/improve physical strength
20. have weight variated 5 kg or over within 2 months
21. eat extremely unbalanced diet
22. have irregular lifestyle due to night work/shift work/others
23. plan to change their lifestyle (exercise/eating habits) during the study
24. have taken health oils (e.g., coconut oil/medium chain triglyceride oil) possibly rich in the ingredients assessed in the study within 3 months/are currently taking
25. take foods rich in ingredients (may affect bowel movements/research field) 4 days weekly or more
26. sometimes substitute sweets or nutritional jellies for meals
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
The Nisshin OilliO Group, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 04 | 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
88
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 | 11 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 24 | 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 | 12 | Month | 04 | Day |
Last modified on
| 2024 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060455
