UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058222 |
|---|---|
| Receipt number | R000066518 |
| Scientific Title | Verification of blood kinetics of experimental foods |
| Date of disclosure of the study information | 2025/06/20 |
| Last modified on | 2025/06/19 15:09:01 |
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Basic information
Public title
Examination of blood concentration of experimental foods after single dose
Acronym
Examination of blood concentration of experimental foods after single dose
Scientific Title
Verification of blood kinetics of experimental foods
Scientific Title:Acronym
Verification of blood kinetics of experimental foods
Region
| Japan |
Condition
Condition
Able-bodied person
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the vitamin C absorption kinetics of experimental foods consisting of multiple formulations in able-bodied person.
Basic objectives2
Others
Basic objectives -Others
Food absorption kinetics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood concentration of active ingredients after ingestion of experimental foods
Key secondary outcomes
Total antioxidant capacity, Adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take 4 types of food containing active ingredients once each
Interventions/Control_2
Take 4 types of food containing active ingredients once each
Interventions/Control_3
Take 4 types of food containing active ingredients once each
Interventions/Control_4
Take 4 types of food containing active ingredients once each
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese men and women aged 20 to 65 years at the time of consent
2) Healthy individuals not undergoing any treatment
3) BMI 18.5 kg/m2 or greater and less than 25.0 kg/m2
4) Able to attend designated examinations and complete records
5) Subjects who have received a full explanation of the study's purpose and contents and voluntarily agreed to participate in the study in writing
Key exclusion criteria
1) Subjects with a history of digestive problems
2) Subjects with drug or food allergies
3) Subjects with hypersensitivity to the experimental foods
4) Subjects who are pregnant or breastfeeding
5) Subjects who have had more than 200 ml of blood drawn within one month prior to the date of consent or more than 400 ml within three months
6) Subjects who drink more than 20g of alcohol per day
7) Subjects who smoke
8) Subjects who regularly use supplements and vitamin preparations (including intravenous drips/injections)
9) Subjects who cannot refrain from taking foods for specified health uses, foods with functional claims, or other so-called health foods during the study period
10) Subjects who cannot take the experimental foods as instructed
11) Subjects who work night shifts or shift work
12) Subjects with renal dysfunction
13) Subjects who are participating in other clinical trials, clinical research, or clinical studies
14) Subjects who cannot follow the instructions of the principal investigator, or who the principal investigator deems inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, JAPAN
TEL
03-6716-0700
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Minami |
| Middle name | |
| Last name | Hanaoka |
Organization
Macromill, Inc.
Division name
Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, JAPAN
TEL
03-6716-0700
Homepage URL
m_hanaoka@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
DHC Corporation
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
Mibyou Research Ethics Review Committee
Address
2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
Tel
03-6272-9163
renraku@npo-mibyou.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
メディカルステーションクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 19 | Day |
Last modified on
| 2025 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066518
