UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049299 |
|---|---|
| Receipt number | R000056132 |
| Scientific Title | Pharmacokinetic test by single ingestion of the test food |
| Date of disclosure of the study information | 2022/10/26 |
| Last modified on | 2022/12/21 17:34:45 |
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Basic information
Public title
Pharmacokinetic test by single ingestion of the test food
Acronym
Pharmacokinetic test by single ingestion of the test food
Scientific Title
Pharmacokinetic test by single ingestion of the test food
Scientific Title:Acronym
Pharmacokinetic test by single ingestion of the test food
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to confirm the pharmacokinetics and safety of hesperetin and polyphenols by single ingestion of the test food.
Basic objectives2
Others
Basic objectives -Others
Pharmacokinetics and safety
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood kinetics of hesperetin
(Blood hesperetin concentration, AUC(0-8h),iAUC(0-8h), Cmax, Tmax)
Key secondary outcomes
*Secondary indexes
Blood kinetics of hesperetin
(AUC(0-inf),T1/2,MRT,Kel)
* Exploratory endpoint
Blood concentration of polyphenols
*Safety
[1] Blood pressure, pulsation.
[2] Weight,body fat percentage,BMI.
[3] Doctor's questions/ Adverse events.
*Other indexes
[1] Baseline characteristics
[2] height measurement
[3] Hematologic test.
[4] Blood biochemical test.
[5] Urine analysis.
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
Single ingestion of the test food.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1] Males and females aged 20-64 years.
[2] Individuals who are healthy and have no chronic physical disease including skin disease.
[3] Individuals whose written informed consent has been obtained after explanation of this study.
[4] Individuals who can have an examination on a designated check day
[5] Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1] Individuals using medical products.
[2] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[3] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[4] Individuals who are a patient or have a history of or endocrine disease.
[5] Individuals with serious anemia
[6] Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
[7] Individuals whose BMI is less than 18.5kg/m2 and over 25.0kg/m2.
[8] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[9] Individuals who have and had a habit to ingest food with Citrus fruits (senshu mandarin orange, orange, lemon, navel, iyokan, bitter orange, shikuwasa), functional claims, health foods, or supplements in the past 1 month or will ingest those foods during the test period.
[10] Individuals who experienced unpleasant feeling during blood drawing.
[11] Individuals whose examination date is menstruation.
[12] Individuals who are sensitive to the test food.
[13] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30mg/day).
[14] Individuals who are or are possibly, or are lactating.
[15] Individuals who participated in other clinical studies in the past 1 month.
[16] Individuals judged inappropriate for the study by the principal.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinic
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nikken Foods 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
| 2022 | Year | 10 | Month | 26 | 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
| 2022 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 04 | 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 | 10 | Month | 24 | Day |
Last modified on
| 2022 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056132
