UMIN-CTR Clinical Trial

Basic information
Public title	A verification study of the reduction on swollen face with the intake of lemon-derived polyphenol (enzyme-treated hesperidin): a randomized, double-blind, placebo-controlled, crossover trial
Acronym	A verification study of the reduction on swollen face with the intake of lemon-derived polyphenol (enzyme-treated hesperidin)
Scientific Title	A verification study of the reduction on swollen face with the intake of lemon-derived polyphenol (enzyme-treated hesperidin): a randomized, double-blind, placebo-controlled, crossover trial
Scientific Title:Acronym	A verification study of the reduction on swollen face with the intake of lemon-derived polyphenol (enzyme-treated hesperidin)
Region	Japan

Condition
Condition	Healthy Japanese adult people
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the reduction on swollen face by test food
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Subjective symptoms on swollen face * Visual Analogue Scale (VAS) * Assessed the item once at screening and in the morning and evening of intervention 1 and 2 before intake and 2 weeks after intake
Key secondary outcomes	1. Wrinkles on facial skin 2. Prominences on facial skin 3. Hemoglobin concentration on facial skin 4. Melanin concentration on facial skin 5. Facial volume 6. Facial dermal water content 7. Leg volume 8. Calf circumference 9. Subjective symptoms 10. Blood pressure *1-4 Measured by ANTERA 3D *5 Measured by VECTRA H1 *6 Measured by MoistureMeter D *7 Measured leg volume by a measuring device *8 Use a measuring tape *9 Assessed subjective symptoms by VAS *1-8 Assessed the items once at screening and in the morning and evening of intervention 1 and 2 before intake and 2 weeks after intake *9 Assessed the items in the morning and evening of intervention 1 and 2 before intake and 2 weeks after intake *10 Assessed the items once at screening and in the morning of intervention 1 and 2 before intake and 2 weeks after intake

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	[1] Duration: 2 weeks Test material: Tablets containing lemon-derived, enzyme-treated hesperidin Administration: Take one tablet after dinner * If you forget to take the tablet, take it in the day. [2] Washout period is for 2 weeks [3] Duration: 2 weeks Test material: Placebo Administration: Take a tablet after dinner * If you forget to take the tablet, take it in the day.
Interventions/Control_2	[1] Duration: 2 weeks Test material: Placebo Administration: Take a tablet after dinner * If you forget to take the tablet, take it in the day. [2] Washout period is for 2 weeks [3] Duration: 2 weeks Test material: Tablets containing lemon-derived, enzyme-treated hesperidin Administration: Take a tablet after dinner * If you forget to take the tablet, take it in the day.
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. Healthy Japanese adult people who are suffering from facial swelling in daily 2. Subjects who are judged as eligible to participate in the study by the physician 3. Subjects who are not detected any renal dysfunction by urinalysis at screening 4. Subjects whose systolic blood pressure is below 130 mmHg at screening 5. Within the subjects who met 2nd to 4th inclusion criteria, select subjects with relatively high score in VAS related to facial swelling at screening
Key exclusion criteria	1. A medical history of malignant tumor, heart failure or myocardial infarction 2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products * Particularly citrus fruits allergy 6. Subjects whose body mass index (BMI) is less than 18.5 kg/m2 or 30 kg/m2 or more 7. Subjects who work late-night shift or are irregular of their life-styles 8. Subjects who are pregnant, lactation, and planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 10. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Middle name Last name Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	SAPPORO HOLDINGS LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 03 Month 06 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	2018 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date	2018 Year 03 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 06 Day
Last modified on	2018 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036082

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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