UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049015 |
|---|---|
| Receipt number | R000055845 |
| Scientific Title | Study on the utilization of dietary fiber from cereals by intestinal bacteria : an exploratory study |
| Date of disclosure of the study information | 2022/09/26 |
| Last modified on | 2023/09/12 10:05:17 |
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Basic information
Public title
Study on the utilization of dietary fiber from cereals by intestinal bacteria : an exploratory study
Acronym
Study on the utilization of dietary fiber by intestinal bacteria : an exploratory study
Scientific Title
Study on the utilization of dietary fiber from cereals by intestinal bacteria : an exploratory study
Scientific Title:Acronym
Study on the utilization of dietary fiber by intestinal bacteria : an exploratory study
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the change of breath hydrogen concentrations after dietary fiber intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Breath hydrogen concentrations
Key secondary outcomes
Blood glucose level, Gastrointestinal hormone(PYY), VAS (Hunger, Fullness, Desire-to-eat, Prospective Food Consumption, Thirst, Comfort)
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of active food
Interventions/Control_2
Single intake of placebo food
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy adults range in age from 20 to 40 at the time of informed consent.
2. Subjects whose defecation frequency are more than 3 times a week
3. Subjects with a BMI of 18.5 or more and less than 25.
4. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1. Subjects with food allergies
2. Subjects who suffer from serious disorders of liver, kidney, heart, lung, digestive organs (including gastric resection), diabetes, rheumatoid arthritis, neurological/mental diseases, endocrine diseases, or other serious and/or progressive diseases.
3. Heavy drinkers (weekly average of 30 g / day or more of pure alcohol)
4. Smoker
5. Subjects who regularly take supplements and health foods for intestinal function or containing prebiotics (e.g. Oligosaccharide, dietary fiber)
6. Subjects who are currently pregnant or breastfeeding, or who wish to become pregnant during the test period.
7. Subjects who donated more than 200ml blood within the past 1 month
8. Subjects who participate in other clinical trials within the past 3 months or have plans to participate in other clinical trials during this study period
9. Subjects who determine ineligible by the principal investigator or the co-investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Takasugi |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
+81-42-632-5810
satoshi.takasugi@meiji.com
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Kawai |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
+81-42-632-5810
Homepage URL
yoshitaka.kawai@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
Tel
042-632-5900
MEIJI.IRB@meiji.com
Secondary IDs
Secondary IDs
YES
Study ID_1
MIJ22C4
Org. issuing International ID_1
CPCC Company Limited
Study ID_2
2022-007
Org. issuing International ID_2
Meiji Co., Ltd.
IND to MHLW
Institutions
Institutions
チヨダパラメディカルケアクリニック（Chiyoda Paramedical Care Clinic）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | 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
10
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
| 2022 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 01 | Month | 23 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 26 | Day |
Last modified on
| 2023 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055845
