Unique ID issued by UMIN | UMIN000045184 |
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Receipt number | R000051608 |
Scientific Title | A Study for Biokinetics of a Functional Food for Healthy Adult Males and Females. |
Date of disclosure of the study information | 2021/08/18 |
Last modified on | 2022/01/31 16:13:47 |
A Study for Biokinetics of a Functional Food for Healthy Adult Males and Females.
A Study for Biokinetics of a Functional Food for Healthy Adult Males and Females.
A Study for Biokinetics of a Functional Food for Healthy Adult Males and Females.
A Study for Biokinetics of a Functional Food for Healthy Adult Males and Females.
Japan |
No
Not applicable | Adult |
Others
NO
This study aims to examine biokinetics of a functional food for healthy adult males and females.
Pharmacokinetics
Indexes for biokinetics
(AUC [0-24h], iAUC [0-24h] and Cmax:before ingestion of the test product, and 30 minutes,1,2,4,6,12, and 24 hours after ingestion of the test product.)
*Secondary indexes
[1]Indexes for biokinetics
(Tmax, AUC [0-inf], T1/2, MRT, Kel:before ingestion of the test product, and 30 minutes,1,2,4,6,12, and 24 hours after ingestion of the test product.)
*Safety
[1] Axillary temperature(1)
[2] Blood pressure, pulsation(1)
[3] Hematologic test(2)
[4] Blood biochemical test(2)
[5] Urine analysis(2)
[6] Doctor's questions(1)
[7] Side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed)(1)
[8] Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed)(1)
*Other index
[1] Baseline characteristics(3)
[2] Height(3)
[3] Weight, body fat percentage, BMI(3)
(1): Before ingestion of the test product, and 12 and 24 hours after ingestion of the test product.
(2): Before ingestion of the test product, and 24 hours after ingestion of the test product.
(3): Before ingestion of the test product.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Single ingestion of the test food
20 | years-old | <= |
65 | years-old | > |
Male and Female
[1]Males and females aged 20-64 years.
[2]Individuals who are healthy and have no chronic physical disease including skin disorder.
[3]Individuals whose written informed consent has been obtained.
[4]Individuals who can come to the designated venue for this study and be inspected.
[5]Individuals judged appropriate for the study by the principal.
[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 used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[5]Individuals who are a patient or have a history of or endocrine disease.
[6]Individuals whose BMI is less than 18.5kg/m2 and over 30kg/m2.
[7]Individuals whose systolic and diastolic blood pressures are over 140mmHg and 90mmHg, respectively.
[8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[9]Individuals who experienced unpleasant feeling during blood drawing.
[10]Individuals who are sensitive to the test food.
[11]Individuals who habitually take the foods for specified health uses (FOSHU) or functional food.
[12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[13]Individuals who are or are possibly, or are lactating.
[14]Individuals who participated in other clinical studies in the past one month.
[15]Individuals judged inappropriate for the study by the principal.
12
1st name | Kazumoto |
Middle name | |
Last name | Sasaki |
Medical Corporation Ichigenkai Sasaki Memorial Hospital
Chief Director
359-1144
1-7-25 Nishitokorozawa Tokorozawa-shi Saitama 359-1144, JAPAN
+81-429-23-7751
soumuka@sasaki-memorial.com
1st name | Tatsuo |
Middle name | |
Last name | Uetake |
CXwellness, Inc.
Representative Director
103-0023
516 Nihonbashinagatani Bldg, 3-1-6 Nihonbashihoncho, Chuo-ku, Tokyo 103-0023, JAPAN
+81-80-4163-4418
uetake@cx-wellness.com
CXwellness, Inc.
CloudNine Inc.
Profit organization
Ueno-Asagao Clinic Ethical Review Committee
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81528382485
i.takahashi@tes-h.co.jp
NO
2021 | Year | 08 | Month | 18 | Day |
Unpublished
Completed
2021 | Year | 08 | Month | 02 | Day |
2021 | Year | 08 | Month | 04 | Day |
2021 | Year | 08 | Month | 21 | Day |
2021 | Year | 08 | Month | 22 | Day |
2021 | Year | 08 | Month | 18 | Day |
2022 | Year | 01 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051608
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