UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041442 |
|---|---|
| Receipt number | R000047306 |
| Scientific Title | A study of the effects of food containing dietary fiber on intestinal flora |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2021/08/17 09:27:34 |
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Basic information
Public title
A study of the effects of food containing dietary fiber on intestinal flora
Acronym
A study of the effects of food containing dietary fiber on intestinal flora
Scientific Title
A study of the effects of food containing dietary fiber on intestinal flora
Scientific Title:Acronym
A study of the effects of food containing dietary fiber on intestinal flora
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of legume based foods on diversity of intestinal flora and bowel movements
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diversity of intestinal flora
(Changes in species-level composition ratios)
Key secondary outcomes
･Intestinal metabolites
･Saliva secretory IgA
･defecation frequency
･Questionnaire about physical condition
and mental status
･the change of body weight
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Control foods(14 times ingestion)-Test foods (28 times ingestion)-Control foods(28 times ingestion)
Interventions/Control_2
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Healthy females aged between 20 and 50.
(2) Defecation frequency 3 to 5 times a week
(3) BMI 23.0 or more and less than 25.0
(4) Those who answered that they felt anxious about their physical condition in the questionnaire survey
(5) Those who answered that they felt stressed in the questionnaire survey
(6) Those who had a cold or flu once within a year
Key exclusion criteria
(1) Those who participated in other clinical trials within 1 month
(2) Those who have taken drugs such as antibiotics that affect the intestinal flora, or those who have taken them within one month
(3) Those who cannot stop the additional intake foods containing live bacteria such as lactic acid bacteria, bifidobacteria, and natto bacteria, foods reinforced with oligosaccharides and dietary fiber, health foods (including special health foods) that are considered to be effective in improving constipation, supplements, and pharmaceutical products during the test period (Excludes those taken before the start of the test)
(4) Those who have a disease that requires urgent treatment or who have serious complications
(5) Those who have a history of gastrointestinal disorders that affect digestive absorption and defecation, or have a history of surgery for them
(6) Those who take medicines that have constipation as a side effect
(7) Those who are judged to be inappropriate as a subject from the answers to the subject background questionnaire
(8) Those who are participating or willing to participate in the clinical test of ingesting other foods or using drugs, the test of applying cosmetics and drugs and so on
(9) Those who have a history of drug dependence or alcohol dependence or current medical history of them
(10) Those who are pregnant, planning to become pregnant, or breastfeeding
(11) Those who have some food allergies
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Taguchi |
Organization
Unlog K.K.
Division name
CEO
Zip code
151-0053
Address
107 New State Menor, 2-23-1, Yoyogi, Shibuya-ku, Tokyo, Japan
TEL
03-6276-5587
tagc@unlog.co.jp
Public contact
Name of contact person
| 1st name | Joto |
| Middle name | |
| Last name | Yoshimoto |
Organization
Mizkan Holdings Co., Ltd.
Division name
Central Research Institute
Zip code
475-8585
Address
2-6 Nakamura-Cho, Handa-Shi, Aichi, Japan
TEL
0569-24-5139
Homepage URL
yoshimoto_jyoutou@mizkan.co.jp
Sponsor or person
Institute
Unlog K.K.
Institute
Department
Personal name
Funding Source
Organization
Mizkan Holdings 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
Unlog K.K.
Address
107 New State Menor, 2-23-1, Yoyogi, Shibuya-ku, Tokyo, Japan
Tel
03-6276-5587
mail@unlog.co.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
| 2020 | Year | 09 | Month | 01 | 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
8
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
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 17 | Day |
Last modified on
| 2021 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047306
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
