UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047635 |
|---|---|
| Receipt number | R000054318 |
| Scientific Title | A questionnaire research on the food function |
| Date of disclosure of the study information | 2022/05/06 |
| Last modified on | 2022/10/31 23:35:00 |
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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
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
s-aoe@otsuma.ac.jp
Sponsor or person
Institute
Otsuma Women's University, Faculty of Home Economics, Department of Food Science
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/50090/1689
Number of participants that the trial has enrolled
25
Results
Area under the curve (AUC)between 30 min and 240 min
of the VAS scores of hunger after TB breakfast was
significantly lower than after PB breakfast. AUCs of the VAS scores of satiety after TB breakfast showed a higher tendency. Energy intake at lunch subsequent to TB consumption was significantly lower than PB.
Results date posted
| 2022 | Year | 10 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 09 | Month | 30 | Day |
Baseline Characteristics
The study was conducted as a double-blind randomized crossover design with twenty-five healthy adult men and women.
Participant flow
Recruitment of subjects was carried out through in-house recruitment of male and female employees of food companies A and B in Tokyo.
Adverse events
None
Outcome measures
Energy intake from the lunch was measured from a self-served plate of food minus leftover waste. Subjects' perception scores on hunger, fullness, prospective food consumption, and satiety were assessed using a visual analogue scalebefore and after the breakfast and lunch.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 01 | Day |
Last modified on
| 2022 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054318
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