UMIN-CTR Clinical Trial

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
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	619-0284
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	Ethics Committees of Yoga Allergy Clinic
Address	4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
Tel	03-5491-4478
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055608