UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036058 |
|---|---|
| Receipt number | R000041072 |
| Scientific Title | Effects of consumption of cereal-derived constituent on intestinal environment |
| Date of disclosure of the study information | 2019/03/03 |
| Last modified on | 2020/01/09 14:22:25 |
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Basic information
Public title
Effects of consumption of cereal-derived constituent on intestinal environment
Acronym
Effects of consumption of cereal-derived constituent on intestinal environment
Scientific Title
Effects of consumption of cereal-derived constituent on intestinal environment
Scientific Title:Acronym
Effects of consumption of cereal-derived constituent on intestinal environment
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of consumption of cereal-derived constituent (A-001) on related factors to bowl movement and intestinal environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowl movement (amount of stool, defecation frequency) for the 2-wk consumption period.
Key secondary outcomes
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
2-week consumption of the two test foods with different composition with more than 4-week washout between the interventions.
Ingestion order: food A-001 to food B-001
Interventions/Control_2
2-week consumption of the two test foods with different composition with more than 4-week washout between the interventions.
Ingestion order: food B-001 to food A-001
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
1. defecate two to five times per week
2. provided written informed consent from subjects
Key exclusion criteria
1.Liver, kidney, heart disease, disorder respiration endocrine, metabolism, nervous system consciousness, diabetes, or other diseases
2. Routinely taking laxative product or cathartic
3. Routinely taking health hood which may influence bowel movement
4. Took antibiotic drug within the last month prior to the this study
5. Blood donation of 200 mL or more within l month of this trial
6. Unpleasant feeling during blood drawing
7. Allergy against any constituents in the test diet
8. have a bad stomach after drinking milk
9. pregnant or planning become pregnant
10. judged to be inappropriate as subject by physician in charge
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Saito |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3 Bunka Sumida-ku Tokyo
TEL
03-5630-7456
saito.shinichiro@kao.com
Public contact
Name of contact person
| 1st name | Chizuka |
| Middle name | |
| Last name | Suzuki |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3 Bunka Sumida-ku Tokyo
TEL
03-5630-7456
Homepage URL
suzuki.chizuka@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Kao Corporation Human Research IRB
Address
2-1-3 Bunka Sumida-ku Tokyo
Tel
+81-3-5630-7263
morisaki.naoko@kao.com
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
花王株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 03 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Published
Result
URL related to results and publications
works in progress
Number of participants that the trial has enrolled
17
Results
Significant effect in the primary outcome
Results date posted
| 2020 | Year | 01 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy subjects
Participant flow
17 participants completed and 10 subjects were incorporated into the analyses
Adverse events
No significantly difference was observed between A-001 and B-001.
Outcome measures
Bowl movement (amount of stool, defecation frequency)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 24 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 02 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 03 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 01 | Day |
Last modified on
| 2020 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041072
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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