Unique ID issued by UMIN | UMIN000025263 |
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Receipt number | R000029059 |
Scientific Title | A verification study on swelling reduction effect by plant-derived ingredients containing food |
Date of disclosure of the study information | 2018/02/28 |
Last modified on | 2017/05/02 12:44:48 |
A verification study on swelling reduction effect by plant-derived ingredients containing food
A verification study on swelling reduction effect by plant-derived ingredients containing food
A verification study on swelling reduction effect by plant-derived ingredients containing food
A verification study on swelling reduction effect by plant-derived ingredients containing food
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To verify the effects on the facial swelling after drinking alcohol by test food
Efficacy
Exploratory
Pragmatic
Not applicable
1.Subjective symptoms for swelling: questionnaire
1. Leg swelling
Water tank volume immersion and calf circumference
2. Facial swelling
High resolution analyzed image, moisture, oiliness, skin tone, pigmentation (the number of pigmentations and total area of pigmentations), pores, wrinkle (the number of wrinkles and total length and areas), texture
3. Subjective symptoms related to swelling of health: questionnaire
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Food |
1. Single-dose study
Test materials: 50 mg of plant-derived ingredients containing tablets
Duration: 1 day
Administration: After two hours at intake 8 tablets of the test food, measure swelling
*Drink 350 mL of beer with alcohol content of 5% at night before the examination day
2. Continuation-dose study
Test materials: 50 mg of plant-derived ingredients containing tablet
Duration: 1 week
Administration: Take 8 tablets of the test food per day any time during the day
*Drink 350 mL of beer with alcohol content of 5% at night before the examination day
20 | years-old | <= |
Not applicable |
Female
1. Healthy adults Japanese women
2. Those who received a full explanation of the procedures in the study, and informed consent was documented and signed by all of the participants
1. To diagnose kidney function works abnormity (urine proteins, creatinine etc. as biomarker) by urinalysis
2. Diastolic pressure is more than 135 mmHg
3. Those who are allergic to citrus fruits
4. Those who are pregnant, breast-feeding, or are expected to become pregnant during the test period
5. Those who had and plan to have surgery and/or hospitalization within 2 months before and after the study period of Nov. 2016 to May 2017
6. Others consider as inappropriate for this test by the physician
10
1st name | |
Middle name | |
Last name | Kazuhiko YOSHIKAWA |
SAPPORO HOLDINGS LTD.
Group Research and Development Division
4-20-1 Ebisu, Shibuya-ku, Tokyo.
03-5795-1201
Kazuhiko.yoshikawa@pokkasapporo-fb.co.jp
1st name | |
Middle name | |
Last name | Kazuhiko YOSHIKAWA |
SAPPORO HOLDINGS LTD.
Group Research and Development Division
4-20-1 Ebisu, Shibuya-ku, Tokyo.
03-5795-1201
Kazuhiko.yoshikawa@pokkasapporo-fb.co.jp
SAPPORO HOLDINGS LTD.
None
Self funding
NO
サッポロホールディングス株式会社本社(東京都)
2018 | Year | 02 | Month | 28 | Day |
Unpublished
Completed
2016 | Year | 12 | Month | 12 | Day |
2017 | Year | 01 | Month | 12 | Day |
2017 | Year | 02 | Month | 28 | Day |
2017 | Year | 05 | Month | 31 | Day |
2017 | Year | 05 | Month | 31 | Day |
2017 | Year | 06 | Month | 30 | Day |
2016 | Year | 12 | Month | 13 | Day |
2017 | Year | 05 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029059
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