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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047635
Receipt No. R000054318
Scientific Title A questionnaire research on the food function
Date of disclosure of the study information 2022/05/06
Last modified on 2022/05/01

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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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