UMIN-CTR Clinical Trial

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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