UMIN-CTR Clinical Trial

Basic information
Public title	A questionnaire research on the food function
Acronym	Research on the food function
Scientific Title	A questionnaire research on the food function
Scientific Title:Acronym	Research on the food function
Region	Japan

Condition
Condition	Heathy adults with normal food habit
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the sustaining effect of satiety between Shake foods containing water soluble dietary fiber and not containing water soluble dietary fiber
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Satiety index calculated by Visual Analog Scale (VAS)
Key secondary outcomes	Calorie intake estimated by weight

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	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Shake food containing indigestible malt-dextrin 100g Blended with soy milk 100ml Wash out period; 1 weeks after the first test
Interventions/Control_2	Shake food containing cellulose powder 100g Blended with soy milk 100ml Wash out period; 1 weeks after the first test
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adult men and women: above 20 years old and less than 59 years old at the date of informed consent signature.
Key exclusion criteria	1) The person who suffered from cardiovascular disease, liver disease, kidney disease, digestive organ disease, respiratory disease, diabetes mellitus, or person with those past histories 2) The person who have a history of malignant disease or who are undergoing treatment for chronic diseases 3) The person who are taking a medication 4) The person with a history of drug or food allergy 5) .The person who uses dietary fiber rich supplement (containing seaweed, konjac, psyllium) or whole grain foods (whole grain wheat, brown rice, rye, barley) daily. 6) Pregnant person, person with the intention of the pregnancy during the study time, the person whom I am nursing 7) The person with smoking habbit 8) Person participating in an examination to apply a clinical study now or a history of the participation within one month 9) The person with drug dependency or abuse or the existing above medical history 10) The person whose stool frequency: is not more than 5 days in a week. 11) Others. the person who judged an examination responsibility doctor to be inappropriate as a subject
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Seiichiro Middle name Last name Aoe
Organization	Otsuma Women's University
Division name	Faculty of Home Economics Department Food Science
Zip code	102-8357
Address	12 Sanban-cho,Chiyoda-ku,Tokyo
TEL	+81-3-5275-6048
Email	s-aoe@otsuma.ac.jp

Public contact
Name of contact person	1st name Seiichiro Middle name Last name Aoe
Organization	Otsuma Women's University
Division name	Faculty of Home Economics Department Food Science
Zip code	102-8357
Address	12 Sanban-cho,Chiyoda-ku,Tokyo
TEL	+81-3-5275-6048
Homepage URL
Email	s-aoe@otsuma.ac.jp

Sponsor
Institute	Otsuma Women's University, Faculty of Home Economics, Department of Food Science
Institute
Department

Funding Source
Organization	Unitec Foods Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	ORBIS Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Life Science Research Ethics Committee, Otsuma Women's University
Address	12 Sanban-cho, Chiyoda-ku, Tokyo
Tel	+81-3-5297-5548
Email	kenkyu.s@ml.otsuma.ac.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 05 Month 06 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 03 Month 22 Day
Date of IRB	2022 Year 04 Month 28 Day
Anticipated trial start date	2022 Year 05 Month 10 Day
Last follow-up date	2022 Year 06 Month 30 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 05 Month 01 Day
Last modified on	2022 Year 05 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054318

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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