UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038132 |
|---|---|
| Receipt number | R000043411 |
| Scientific Title | A study for evaluating the effects of intake of fermented plant extract on intestinal environment |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2020/09/09 09:36:01 |
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Basic information
Public title
A study for evaluating the effects of intake of fermented plant extract on intestinal environment
Acronym
A study for evaluating the effects of intake of fermented plant extract on intestinal environment
Scientific Title
A study for evaluating the effects of intake of fermented plant extract on intestinal environment
Scientific Title:Acronym
A study for evaluating the effects of intake of fermented plant extract on intestinal environment
Region
| Japan |
Condition
Condition
Healthy Japanese adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of the test food on improving intestinal environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bacterial flora analysis on Weeks 0, 4, 8, and 12 after initiation.
Key secondary outcomes
Body weight, amount of body fat, amount of skin moisture, amount of moisture loss via the skin, hemoglobin concentration, and subjective symptoms on Weeks 0, 4, 8, and 12 after initiation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test materials: Fermented plant extract supplement
Dose: 3 packs per day(5g x 3)
Administration: Take 1 pack of the test food after breakfast, lunch, and dinner.
Interventions/Control_2
Duration: 12 weeks
Test materials: Placebo control (not containing fermented plant extract)
Dose: 3 packs per day (5g x 3)
Administration: Take 1 pack of the test food after breakfast, lunch, and dinner.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. The age at the time of obtaining a consent is 20 years or older.
2. Female
3. Those from whom a written consent can be obtained on a voluntary basis.
Key exclusion criteria
The person who is unsuitable for the entry judged by an officer.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Takaoka |
Organization
Kobe College
Division name
School of Human Sciences, Department of Biosphere Sciences
Zip code
6628505
Address
4-1 Okadayama, Nishinomiyashi, Hyogo 662-8505 Japan
TEL
0798-51-8668
takaoka@mail.kobe-c.ac.jp
Public contact
Name of contact person
| 1st name | Nobutada |
| Middle name | |
| Last name | Murakami |
Organization
Functional Food Creation Research Institute Co., Ltd.
Division name
Research and Development Dept.
Zip code
7161241
Address
4422-1 Yoshikawa, Kagagun Kibichuocho, Okayama 716-1241 Japan
TEL
0866-56-8771
Homepage URL
n-murakami@kinousei.co.jp
Sponsor or person
Institute
Kobe College
Institute
Department
Personal name
Funding Source
Organization
Functional Food Creation Research Institute Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe College
Address
4-1 Okadayama, Nishinomiyashi, Hyogo 662-8505 Japan
Tel
0798-51-8668
takaoka@mail.kobe-c.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
| 2019 | Year | 10 | 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
20
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
| 2019 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 09 | Month | 27 | Day |
Last modified on
| 2020 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043411
