UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study of the effect of food ingredients on abdominal condition (SWE-2019-02-HBLACT)
Acronym	Exploratory study of the effect of food ingredients on abdominal condition
Scientific Title	Exploratory study of the effect of food ingredients on abdominal condition (SWE-2019-02-HBLACT)
Scientific Title:Acronym	Exploratory study of the effect of food ingredients on abdominal condition
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To exploratory evaluate the effect of food ingredients on abdominal condition.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of subjects with improved abdominal conditions at the end of the trial compared to before intervention.
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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects will take the functional food (high dose) once a day for 4 weeks.
Interventions/Control_2	Subjects will take the functional food (low dose) once a day for 4 weeks.
Interventions/Control_3	Subjects will take the placebo food once a day for 4 weeks.
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) Subjects who are troubled by their abdominal condition. (3) Subjects who can visit hospital on designated day. (4) Subjects who are able to submit the written informed consents.
Key exclusion criteria	(1) Subjects who are with treatment. (2) Subjects who constantly use drug medicine. (3) Subjects who are with history of gastrointestinal surgery. (4) Subjects who are attending other studies or attended other studies within the past 4 weeks. (5) Female in pregnancy, lactation and scheduled pregnancy period. (6) Subjects who are; a) With present heart disorder, liver disorder, kidney disorder or gastrointestinal tract disorder, b) With history of cardiac disorder or gastrointestinal tract disorder, c) With diabetes mellitus, or d) With allergy to the study foods. (7) Subjects who are not negative by virus immune serology test result at the time of screening. (8) Subjects who are deemed to be unsuitable by the investigator.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Takayuki Middle name Last name Izumo
Organization	SUNTORY WELLNESS LIMITED
Division name	Institute for Health Care Science
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0630
Email	Takayuki_Izumo@suntory.co.jp

Public contact
Name of contact person	1st name Ken-ichi Middle name Last name Wakabayashi
Organization	SUNTORY WELLNESS LIMITED
Division name	Institute for Health Care Science
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0599
Homepage URL
Email	Kenichi_Wakabayashi@suntory.co.jp

Sponsor
Institute	SUNTORY WELLNESS LIMITED
Institute
Department

Funding Source
Organization	SUNTORY WELLNESS LIMITED
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	Miyawaki Orthopedic Clinic Institutional Review Board
Address	3-1-6 Ariakecho, Eniwa City, Hokkaido
Tel	0123-33-4026
Email	d-kameda@mediffom.co.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	2019 Year 05 Month 12 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	Completed
Date of protocol fixation	2019 Year 05 Month 09 Day
Date of IRB	2019 Year 04 Month 22 Day
Anticipated trial start date	2019 Year 05 Month 13 Day
Last follow-up date	2019 Year 08 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 10 Day
Last modified on	2021 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041803