UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052082 |
|---|---|
| Receipt number | R000059348 |
| Scientific Title | Study to examine changes in biomarkers in blood sample due to ingestion of test food |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2024/02/07 13:41:55 |
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Basic information
Public title
Study to examine changes in biomarkers in blood sample due to ingestion of test food
Acronym
Study to examine changes in biomarkers in blood sample due to ingestion of test food
Scientific Title
Study to examine changes in biomarkers in blood sample due to ingestion of test food
Scientific Title:Acronym
Study to examine changes in biomarkers in blood sample due to ingestion of test food
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the changes in biomarkers in blood sample due to the consumption of the test food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
biomarkers in blood sample
Key secondary outcomes
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
Oral ingestion of the test food for 2 weeks
Interventions/Control_2
Oral ingestion of the placebo food for 2 weeks
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged over 20 to under 70 when informed consent.
2) Individuals with a BMI >= 20
3) Individuals who have received enough explanation and understood about this study, and who can obtain informed consent.
Key exclusion criteria
1) Individuals who take foods more than three times a week with functional claims or foods or supplements containing polyphenols, or will take them for this test period.
2) Individuals who are aware of severe symptoms such as irregular menstruation, menstrual cramps, and symptoms related to menopausal disorders.
3) Individuals who participated in other clinical studies in the past 4 weeks, or will participate during this test period.
4) Individuals who are heavy alcohol drinker.
5) Individuals with a history of hepatopathy, kidney damage, heart disease, and gastrointestinal disease at present or within the past 5 years.
6) Individuals who are allergic to foods or medicines.
7) Females who are or are possibly pregnant, or are lactating.
8) Individuals who donated total more than 200mL whole blood or blood component in the past 1 month.
9) Males who donated total more than 400mL whole blood in the past 3 months.
10) Females who donated total more than 400mL whole blood in the past 4 months.
11) Males who will donate total more than 1200mL blood in the past 12 months and this test period.
12) Females who will donate total more than 800mL blood in the past 8 months and this test period.
13) Individuals judged inappropriate for this study by the principal investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Kawama |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
t-kawama-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Shinpei |
| Middle name | |
| Last name | Kawakami |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
Homepage URL
s-kawakami-jf@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
Chiyoda paramedical care clinic Institutional Review Board
Address
3-3-10 Honngokucyo Nihonbashi Cyuo-ku Tokyo
Tel
0362259005
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 | 12 | Month | 31 | 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 | 08 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 29 | 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 | 09 | Month | 01 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059348
| 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 |
