UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048889 |
|---|---|
| Receipt number | R000055707 |
| Scientific Title | Improving effect of bowel movement by the test food consumption : randomized placebo-controlled, double-blind, crossover controlled trial |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2023/05/15 11:19:30 |
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Basic information
Public title
Improving effect of bowel movement by the test food consumption
Acronym
Improving effect of bowel movement by the test food consumption
Scientific Title
Improving effect of bowel movement by the test food consumption : randomized placebo-controlled, double-blind, crossover controlled trial
Scientific Title:Acronym
Improving effect of bowel movement by the test food consumption
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effect of test food intake on bowel movements and intestinal environment in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Defecation survey (frequency of defecations)
Key secondary outcomes
Defecation survey (defecation volume and fecal properties), intestinal flora
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 2 weeks
Dose: Take 1 bag a day
Interventions/Control_2
Duration: 2 weeks
Dose: Take 2 bag a day
Interventions/Control_3
Duration: 2 weeks
Dose: Take 1 bag (placebo)
Interventions/Control_4
Duration: 2 weeks
Dose: Take 2 bag (placebo)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese adults
2. Persons who defecate 3 to 5 times per week
Key exclusion criteria
1. Those who are receiving treatment for any disease (including medication treatment) at a medical institution
2. Those who are currently or have a history of serious illness
3. Those who take intestinal medicine or constipation medicine daily
4. Those who consume foods for Specified Health Uses, Foods with Functional Claims, yogurt, and lactic acid bacteria beverages that are thought to be involved in intestinal rectification daily
5. Those who habitually consume supplements and fortified foods daily
6. Those who have a current or history of drug allergy or food allergy (those who may cause allergic symptoms to the test food)
7. Those who are currently pregnant or breastfeeding, or who wish to become pregnant during the examination period
8. Those who participated in other clinical trials within one month of obtaining consent, those who are currently participating, or those who plan to participate during the study period
9. Those who work in shifts, late at night, etc. and have an irregular life rhythm
10. Those who drink a lot of alcohol on a daily basis (60 g / day in terms of alcohol)
11. Those who smoke
12. Those who are judged by the Principal Investigator to be inappropriate for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Graduate School of Kyushu University Faculty of Agriculture
Division name
Department of Agri-Environmental Sciences Laboratory of Systematic Forest and Forest Products Sciences
Zip code
812-8582
Address
744 Motooka, Nishi-ku, Fukuoka, Fukuoka, JAPAN
TEL
092-802-4673
shimizu@agr.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Graduate School of Kyushu University Faculty of Agriculture
Division name
Department of Agri-Environmental Sciences Laboratory of Systematic Forest and Forest Products Scienc
Zip code
812-8582
Address
744 Motooka, Nishi-ku, Fukuoka, Fukuoka, JAPAN
TEL
092-802-4673
Homepage URL
shimizu@agr.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
BEST AMENITY 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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Building, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1590
jimukyoku@mail.souken-r.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
九州大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | 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 | 07 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 01 | 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 | 09 | Month | 08 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055707
