UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A verification study on swelling reduction effect by plant-derived ingredients containing food
Title of the study (Brief title)	A verification study on swelling reduction effect by plant-derived ingredients containing food
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects on the facial swelling after drinking alcohol by test food
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1.Subjective symptoms for swelling: questionnaire
Key secondary outcomes	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

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	Treatment
Type of intervention	Food
Interventions/Control_1	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
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	Female
Key inclusion criteria	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
Key exclusion criteria	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
Target sample size	10

Research contact person
Name of lead principal investigator	Kazuhiko YOSHIKAWA
Organization	SAPPORO HOLDINGS LTD.
Division name	Group Research and Development Division
Address	4-20-1 Ebisu, Shibuya-ku, Tokyo.
TEL	03-5795-1201
Email	Kazuhiko.yoshikawa@pokkasapporo-fb.co.jp

Public contact
Name of contact person	Kazuhiko YOSHIKAWA
Organization	SAPPORO HOLDINGS LTD.
Division name	Group Research and Development Division
Address	4-20-1 Ebisu, Shibuya-ku, Tokyo.
TEL	03-5795-1201
Homepage URL
Email	Kazuhiko.yoshikawa@pokkasapporo-fb.co.jp

Sponsor
Institute	SAPPORO HOLDINGS LTD.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	サッポロホールディングス株式会社本社（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 12 Day
Anticipated trial start date	2017 Year 01 Month 12 Day
Last follow-up date	2017 Year 02 Month 28 Day
Date of closure to data entry	2017 Year 05 Month 31 Day
Date trial data considered complete	2017 Year 05 Month 31 Day
Date analysis concluded	2017 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 13 Day
Last modified on	2017 Year 05 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029059