UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053197 |
|---|---|
| Receipt number | R000060684 |
| Scientific Title | Verification of the effect of test food on the intestinal environment |
| Date of disclosure of the study information | 2024/01/24 |
| Last modified on | 2024/03/29 15:11:47 |
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Basic information
Public title
Verification of the effect of test food on the intestinal environment
Acronym
Verification of the effect of test food on the intestinal environment
Scientific Title
Verification of the effect of test food on the intestinal environment
Scientific Title:Acronym
Verification of the effect of test food on the intestinal environment
Region
| Japan |
Condition
Condition
non-handicapped person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will scientifically verify, through subjective and physiological evaluations, whether the consumption of the test food alters the intestinal microflora and whether it has a secondary relaxing effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intestinal microflora
Key secondary outcomes
VAS
Blood short-chain fatty acids
EEG
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food (2 weeks) to Washout period (2 weeks) to Placebo (2 weeks)
Interventions/Control_2
Placebo (2 weeks) to Washout period (2 weeks) to Test food (2 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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Japanese national whose native language is Japanese
(2) Age at the time of measurement must be between 20 and 60 years old.
(3) Constipation tendency (average of 3 to 5 bowel movements per week)
However, the defecation status up to the time of screening should be confirmed in the Defecation diary, and subjects should be selected.
(4) BMI 18.5 to 25
Key exclusion criteria
(1)Those who have a bowel movement every day
(2)Those who are receiving treatment (including medication) for some disease at a medical institution
(3)Those who have a current or previous serious disease
(4)Those who are taking intestinal regulators or laxatives on a daily basis.
(5)Those who routinely consume food for specified health use, functional foods, yogurt, or lactic acid bacteria beverages that are thought to be involved in intestinal regulation.
(6)Those who habitually take supplements or nutrient-fortified foods on a daily basis
(7)Those who have drug allergy or food allergy or have a history of such allergy.(Those who are at risk of developing allergic symptoms to the test food)
(8)Those who have participated or are currently participating in other clinical trials within 1 month of obtaining consent, or those who plan to participate during the study period
(9)Those who have an irregular rhythm of life, such as shift work, late-night work, etc.
(10)Those who drink a lot of alcohol on a daily basis (alcohol equivalent to 60g/day)
(11)Smoking
(12)Patients who are judged to be inappropriate for this study by the investigator.
(13)BMI less than 18.5 or greater than 25
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kenjirou |
| Middle name | |
| Last name | Hara |
Organization
Fuji Nihon Seito Corporation
Division name
Functional Food Sales Department
Zip code
424-0924
Address
1-4-10 Sheikai Shimizu-ku Shizuoka City Shizuoka Ken
TEL
054-334-5357
kenjirou.hara@fnsugar.co.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Miyazaki |
Organization
Faculty of Agriculture,Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
815-8540
Address
Room 403, GIC Building, 4-9-1 Shiobara, Minami-ku, Fukuoka City
TEL
092-553-9458
Homepage URL
miyazaki.hitomi.309@m.kyushu-u.ac.jp
Sponsor or person
Institute
Fuji Nihon Seito Corporation
Institute
Department
Personal name
Kenjirou Hara
Funding Source
Organization
Fuji Nihon Seito Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Agriculture,Kyushu University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Building 6F, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
0354081590
shiba_palace@s-palace-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
九州大学大橋キャンパス
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 24 | 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
0
Results
Revise the research plan because the required number of subjects could not be collected.
Results date posted
| 2024 | Year | 03 | Month | 29 | Day |
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
Terminated
Date of protocol fixation
| 2023 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 12 | Month | 22 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060684
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
