UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047068 |
|---|---|
| Receipt number | R000053695 |
| Scientific Title | The verification for the time-dependent change of blood metabolites of the test food: a crossover comparison trial |
| Date of disclosure of the study information | 2022/03/03 |
| Last modified on | 2022/04/26 17:27:26 |
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Basic information
Public title
The verification for the time-dependent change of blood metabolites of the test food
Acronym
The verification for the time-dependent change of blood metabolites of the test food
Scientific Title
The verification for the time-dependent change of blood metabolites of the test food: a crossover comparison trial
Scientific Title:Acronym
The verification for the time-dependent change of blood metabolites of the test food
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the change of blood metabolites of the test food A and B
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The area under the curve of blood metabolites concentration
Key secondary outcomes
The maximum blood concentration of metabolites, the measured values at each assessment point* of blood metabolites concentration, and metabolites concentration in 24-hour urine collection
*It indicates before test-food consumption, at one, two, four, six, and 24 hours after test-food consumption
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food:
(1) Test food A
(2) Test food B
Administration:
<Test food A>After taking blood samples before intake, take test food A (270 mg) with water (100 mL)
<Test food B>After taking blood samples before intake, take test food B (300 mg) with water (100 mL)
*The intervention sequence is test food A to test food B, and each food is single ingestion.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Male or female
3. Subjects aged 20 or more
4. Healthy subjects
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use
5. Subjects currently taking medicines (include herbal medicines) and supplements
6. Subjects who are allergic to medications and/or the test-food-related products
7. Subjects who are pregnant, breast-feeding, and planning to become pregnant
8. Subjects who suffer from COVID-19
9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
10. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Yushi |
| Middle name | |
| Last name | Hashizume |
Organization
Toyo Sugar Refining Co., Ltd.
Division name
Research & Development Department
Zip code
103-0016
Address
Yoto Bldg., 18-20, Nihonbashikoami-cho, Chuo-ku, Tokyo, Japan.
TEL
03-3668-7874
Homepage URL
hashizume-y@toyosugar.co.jp
Sponsor or person
Institute
Toyo Sugar Refining Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Toyo Sugar Refining Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
University of Miyazaki
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
IRB@takara-clinic.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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 03 | 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
8
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
| 2022 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 03 | Day |
Last modified on
| 2022 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053695
