UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044338 |
|---|---|
| Receipt number | R000050599 |
| Scientific Title | Effect of daily dietary fiber supplementation on appetite and eating behavior |
| Date of disclosure of the study information | 2021/05/26 |
| Last modified on | 2025/03/18 02:22:58 |
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Basic information
Public title
Effect of daily dietary fiber supplementation on appetite and eating behavior
Acronym
Effect of daily dietary fiber supplementation on appetite and eating behavior
Scientific Title
Effect of daily dietary fiber supplementation on appetite and eating behavior
Scientific Title:Acronym
Effect of daily dietary fiber supplementation on appetite and eating behavior
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of daily inulin supplementation on obesity-related eating behavior and appetite.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response to food cue
Key secondary outcomes
Blood level of appetite regulating hormones
Daily eating behavior
Gut microbiome
Fecal level of short chain fatty acids and metabolites
Body composition
H2 and CH4 levels in breath
Physical activity
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily inulin supplementation
Interventions/Control_2
Daily placebo supplementation
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age 20-49 yrs
Key exclusion criteria
Exclusion criteria include history of intestinal disease or cognitive impairment or mood disorder, and daily use of prebiotics or probiotics supplementation within a month.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | KANA |
| Middle name | |
| Last name | KONISHI |
Organization
Toyo University
Division name
Department of Food Life Sciences
Zip code
3740193
Address
1-1-1 Izumino, Itakura, Oura, Gunma
TEL
0276-82-9208
konishi@toyo.jp
Public contact
Name of contact person
| 1st name | KANA |
| Middle name | |
| Last name | KONISHI |
Organization
Toyo University
Division name
Department of Food Life Sciences
Zip code
3740193
Address
1-1-1 Izumino, Itakura, Oura, Gunma
TEL
0276-82-9208
Homepage URL
konishi@toyo.jp
Sponsor or person
Institute
Toyo University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address
2100 Kujirai, Kawagoe city, Saitama, Japan
Tel
0492391440
mlkks@toyo.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
| 2021 | Year | 05 | Month | 26 | 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
26
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050599
