UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038106 |
|---|---|
| Receipt number | R000043424 |
| Scientific Title | A study to evaluate the effects of a test food on intestinal environment and mental states in healthy Japanese subjects : a randomized, double blind, placebo controlled trial |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2023/03/27 09:12:17 |
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Basic information
Public title
A study to evaluate the effects of a test food on intestinal environment and mental states
Acronym
A study to evaluate the effects of a test food on intestinal environment and mental states
Scientific Title
A study to evaluate the effects of a test food on intestinal environment and mental states in healthy Japanese subjects : a randomized, double blind, placebo controlled trial
Scientific Title:Acronym
A study to evaluate the effects of a test food on intestinal environment and mental states
Region
| Japan |
Condition
Condition
None(Healthy Japanese adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of the test food on intestinal environment and mental states
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Intestinal environment, mental states (Questionnaire survey)
Key secondary outcomes
Safety assessment
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
Intake of a test food containing with food composition A
Interventions/Control_2
Intake of a placebo (0 mg of food composition A)
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
Male and Female
Key inclusion criteria
(1) Japanese adult subjects
(2) Healthy subjects (Subjects who feel depression)
Key exclusion criteria
(1) Subjects who have IBS (Irritable bowel syndrome), heart disease, liver disorder, renal disorder, blood disease, lung disease, or a medical history of these.
(2) Subjects who have an intestinal organic disease.
(3) Subjects who have a medical history of severe allergies.
(4) Subjects who have alcoholism, drug addiction, eating disorder, or a medical history of these. In addition, subjects with complication of mental disease such as intellectual disabilities.
(5) Subjects who are or may be pregnant.
(6) Subjects who are taking antibiotics.
(7) Subjects who do not intake carbohydrate at least once a day.
(8) Subjects who have participated in other clinical trial within the last three months or are currently participating other clinical trial.
(9) Subjects who are judged as unsuitable for the study by the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Fukudo |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Behavioral Medicine
Zip code
980-8575
Address
2-1 Seiryo, Aoba, Sendai, Miyagi, Japan
TEL
022-717-8214
sfukudo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Emiko |
| Middle name | |
| Last name | Aizawa |
Organization
Department of Human Life Science, Nagoya University of Economics
Division name
Department of Nutritional Science
Zip code
484-8504
Address
61-1 uchikubo, Inuyama, Aichi, Japan
TEL
0568-67-0511
Homepage URL
eaizawa@nagoya-ku.ac.jp
Sponsor or person
Institute
Nagoya University of Economics
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Healthcare Laboratory 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
Shiba Palace Clinic
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | 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
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 | 18 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | 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 | 26 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043424
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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