UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048839 |
|---|---|
| Receipt number | R000055608 |
| Scientific Title | Exploratory study of the effect of single intake of food ingredients on bowel condition |
| Date of disclosure of the study information | 2022/09/22 |
| Last modified on | 2022/09/02 21:08:26 |
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Basic information
Public title
Exploratory study of the effect of single intake of food ingredients on bowel condition
Acronym
Exploratory study of the effect of single intake of food ingredients on bowel condition
Scientific Title
Exploratory study of the effect of single intake of food ingredients on bowel condition
Scientific Title:Acronym
Exploratory study of the effect of single intake of food ingredients on bowel condition
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory assesment of the effect of single intake of food ingredients on bowel condition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel index
Key secondary outcomes
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
Single intake of the test food on the day of the study
Wash out (1 week or more)
Single intake of the placebo food on the day of the study
Interventions/Control_2
Single intake of the placebo food on the day of the study
Wash out (1 week or more)
Single intake of the test food on the day of the study
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) Male and Female whose age are 20 <= years old <65.
(2) Employees of Suntory Holdings registry at Suntory World Research Center.
(3) Subjects who can submit the informed consents.
Key exclusion criteria
(1) Subjects whose systolic blood pressure is less than 90 mmHg at the most recent physical examination or physical checkup.
(2) Subjects who are pregnant or lactating.
(3) Subjects who are participating in other clinical studies, or who finished clinical study within the last 4 weeks.
(4) Subjects who are;
a) With disease on heart, liver, kidney or other organs complications.
b) With a previous history of disease on circulatory organs.
c) Contracting diabetes.
d) With test food allergy.
(5) Subjects who are undergoing some medical treatment at the time of the eligibility assessment test.
(6) Subjects who constantly use medicines, foods for specified health use, foods with functional indications, health foods, etc. related to intestinal regulation.
(7) Subjects who have had or are currently suffering from serious intestinal diseases (ulcerative colitis, Crohn's disease, colorectal cancer, appendicitis, etc)
(8) Subjects with a cardiac pacemaker.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Zeida |
Organization
Suntory Global Innovation Center Ltd.
Division name
Research Institute
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0464
Mitsuhiro_Zeida@suntory.co.jp
Public contact
Name of contact person
| 1st name | Norimasa |
| Middle name | |
| Last name | Kanegawa |
Organization
Suntory Global Innovation Center Ltd.
Division name
Research Institute
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0556
Homepage URL
Norimasa_Kanegawa@suntory.co.jp
Sponsor or person
Institute
Suntory Global Innovation Center Ltd.
Institute
Department
Personal name
Funding Source
Organization
Suntory Global Innovation Center Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committees of Yoga Allergy Clinic
Address
4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
Tel
03-5491-4478
info@yg-allergy.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 28 | 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 | 02 | Day |
Last modified on
| 2022 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055608
