UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047914 |
|---|---|
| Receipt number | R000054608 |
| Scientific Title | Exploratory study of the effect of continuous intake of food ingredients on bowel condition |
| Date of disclosure of the study information | 2022/06/22 |
| Last modified on | 2022/06/01 16:20:13 |
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Basic information
Public title
Exploratory study of the effect of continuous intake of food ingredients on bowel condition
Acronym
Exploratory study of the effect of continuous intake of food ingredients on bowel condition
Scientific Title
Exploratory study of the effect of continuous intake of food ingredients on bowel condition
Scientific Title:Acronym
Exploratory study of the effect of continuous 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 continuous 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
Parallel
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
Subjects will take the placebo food once a day for 4 weeks.
Interventions/Control_2
Subjects will take the functional food 1 once a day for 4 weeks.
Interventions/Control_3
Subjects will take the functional food 2 once a day for 4 weeks.
Interventions/Control_4
Subjects will take the comparative food once a day for 4 weeks. This group is open but assessor(s) are blinded, because it is deferent in form from placebo food and functional food.
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) Subjects who can use a iPhone without any problems.
(3) Subjects who can receive explanations and inspections in a remote environment.
(4) Subjects who can submit the informed consents.
Key exclusion criteria
(1) Subjects who are undergoing some medical treatment at the onset of this study.
(2) Subjects who are pregnant, lactation,(or planning to become pregnant)
(3) Subjects whose systolic blood pressure is less than 90mmHg.
(4) Subjects who are still participating in other clinical studies, or who finished clinical study within the last 4 weeks.
(5) 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) Have diabetes mellitus.
d) With test food allergy.
(6) Subjects who are constantly taking certain drug medicine, or who are expecting taking it within the period of current study, or who have indispensable supplements, functional foods affecting the test results.
(7) Subjects who have severe allergic reaction to medicines and/or test food related products.
(8) Subjects who drink over 60 g of alcohol per day on average.
(9) Subjects who have irregular eating patterns.
(10) Subjects who work irregular hours such as late night, or those who plan to do so in the future.
(11) Subjects who plan to change their lifestyle during the scheduled study period.
(12) Subjects whose BMI is less than 18.5 or over 30.0 kg/m2.
(13) Subjects who have had or are currently suffering from serious intestinal diseases (ulcerative colitis, Crohn's disease, colorectal cancer, appendicitis, etc)
(14) Subjects with a cardiac pacemaker.
(15) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
240
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
6190284
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
6190284
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
Healthcare Systems Co., Ltd.
Address
4-6-15, Shimmbashi, Minato-ku, Tokyo
Tel
03-6809-2722
soumu@hc-sys.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
| 2022 | Year | 06 | 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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 22 | 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 | 06 | Month | 01 | Day |
Last modified on
| 2022 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054608
