UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051814 |
|---|---|
| Receipt number | R000059129 |
| Scientific Title | A study to investigate the effects of a 4-week intake of the test food on the intestinal environment and the disposition of the test food after a single intake of the test food. |
| Date of disclosure of the study information | 2023/08/04 |
| Last modified on | 2024/07/29 19:33:11 |
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Basic information
Public title
A study to investigate the effects of a 4-week intake of the test food on the intestinal environment and the disposition of the test food after a single intake of the test food.
Acronym
A study to investigate the effects of a 4-week intake of the test food on the intestinal environment and the disposition of the test food after a single intake of the test food.
Scientific Title
A study to investigate the effects of a 4-week intake of the test food on the intestinal environment and the disposition of the test food after a single intake of the test food.
Scientific Title:Acronym
A study to investigate the effects of a 4-week intake of the test food on the intestinal environment and the disposition of the test food after a single intake of the test food.
Region
| Japan |
Condition
Condition
Healthy male adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of a 4-week intake of the test food on the intestinal environment and the disposition of the test food after a single intake of the test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemodynamic tests (quercetin, quercetin conjugates, quercetin metabolites)
Key secondary outcomes
Intestinal microbiota
Intestinal metabolites
Urinary metabolites (quercetin, quercetin conjugates, quercetin metabolites)
Blood inflammatory system test (IL-6, TNF-alpha)
Blood nervous system test (serotonin)
Salivary stress test (chromogranin A, cortisol)
Skin test (stratum corneum water content, transdermal water transpiration, skin viscoelasticity)
Defecation status (frequency, number of days, amount, consistency, color, feeling of incomplete evacuation, abdominal pain)
Eating habits and lifestyle questionnaire
Body composition
POMS2 short version
abbreviated version - VAS for body sensation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Take two tablets of the test food per day -> washout -> Take two tablets of the control food per day
Interventions/Control_2
Take two tablets of the control food per day -> washout -> Take two tablets of the test food per day
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
(1) At informed consent, male subjects aged more than or equal to 18, and less than 60 years old.
(2) Subjects who can show their understanding of the study procedure and agreement with participating in the study by written informed consent prior to the study.
Key exclusion criteria
(1)Subjects who have a plan or who have taken the food containing quercetin within a month before the trial start or during the trial.
(2)Subjects who have a plan or who have taken medication within a month before the pre-test start or during the trial, which would affect the trial result.
(3)Subjects who had undergone appendectomy.
(4)Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent.
(5)Subjects who are expected to undergo major changes in their living environment such as home and work during this trial.
(6)Subjects with irregular dietary habits.
(7)Subjects who take excessive alcohol.
(8)Subjects whose roomer is planning to join this trial.
(9)Subjects who are now under other clinical tests with some kind of medicine/food, or participated in those within 4 weeks before this trial, or will join those after giving informed consent to participate in this trial.
(10)Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases.
(11)Subjects who are allergic to medicines and test foods (related to lactic acid bacteria).
(12)Subjects who donated their blood components, and/or whole blood 200 mL within a month before the trial start.
(13)Subjects who donated their blood components, and/or whole blood 400 mL within 3 months before the trial start.
(14)Subjects whose collected blood volume within the last 12 months before the trial start would reach to 1,200 mL after adding the blood collection in this study.
(15) Others who have been determined ineligible by the principal/sub investigator.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Murakami |
Organization
Metagen, Inc.
Division name
Headquarters
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Murakami |
Organization
Metagen, Inc.
Division name
Headquarters
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
Homepage URL
research@metagen.co.jp
Sponsor or person
Institute
Metagen, Inc.
Institute
Department
Personal name
Funding Source
Organization
Alps Pharmaceutical Ind. 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashihongoku-cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
+81-3-6225-9005
IRB@cpcc.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
| 2023 | Year | 08 | Month | 04 | 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
| 2023 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 03 | Day |
Last modified on
| 2024 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059129
