UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055494 |
|---|---|
| Receipt number | R000063412 |
| Scientific Title | Safety evaluation of excessive intake of food containing flavonoids for healthy adults. |
| Date of disclosure of the study information | 2024/09/13 |
| Last modified on | 2025/02/21 15:50:02 |
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Basic information
Public title
Safety evaluation of excessive intake of food containing flavonoids for healthy adults.
Acronym
Safety evaluation of excessive intake of food containing flavonoids for healthy adults.
Scientific Title
Safety evaluation of excessive intake of food containing flavonoids for healthy adults.
Scientific Title:Acronym
Safety evaluation of excessive intake of food containing flavonoids for healthy adults.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive intake of food containing flavonoids, 5-fold quantity of recommended daily intake (500 mg), for 4 weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview, before and 2, 4 weeks after intake and 2 weeks after the end of intake period and Adverse events thorough the study
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of food containing flavonoids, 5-fold quantity of recommended daily intake, for 4 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy male and female between the ages of 18 and 64
Key exclusion criteria
(1) Subjects who are taking health foods that mainly contain polyphenols
(2) Subjects who are judged as unsuitable for this study by the principal investigator based on the results of clinical examination or cardiopulmonary abnormality
(3) Subjects having possibilities for emerging allergy related to the study
(4) Subjects having a disease requiring regular medication or a history of serious diseases for which medication was required
(5) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(6) Subjects who work in shifts or late at night and have an irregular daily rhythm
(7) Subjects who have a disease that requires constant medication, those who have a disease under treatment, those who have a history of serious disease that required medication
(8) Subjects who intend to become pregnant or lactating
(9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(10) Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Hattori |
Organization
TOWA PHARMACEUTICAL CO.,LTD
Division name
Healthcare Business Promotion Department Business Development Unit
Zip code
571-8580
Address
2-11 Shinbashi-cho, Kadoma, Osaka
TEL
06-7175-7680
ms-hattori@towayakuhin.co.jp
Public contact
Name of contact person
| 1st name | Yoshimi |
| Middle name | |
| Last name | Bansho |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department Trial Planning Section
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
070-3023-8209
Homepage URL
bansho.yoshimi189@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOWA PHARMACEUTICAL 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.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
メディカルステーションクリニック (Medical station clinic) (東京都)、医療法人社団 きんせい湯 神楽坂泌尿器科クリニック (Kagurazaka Urology Clinic) （東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 13 | 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
| 2024 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 13 | Day |
Last modified on
| 2025 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063412
