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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047914
Receipt No. 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

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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
Email 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
Email Norimasa_Kanegawa@suntory.co.jp

Sponsor
Institute Suntory Global Innovation Center Ltd.
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054608

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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