UMIN-CTR Clinical Trial

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

Healthy Japanese adult people

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

SAPPORO HOLDINGS LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2018

Year

03

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

03

Month

06

Day

Last modified on

2018

Year

08

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036082