UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on skin in healthy Japanese

Acronym

Effects of consumption of the test food on skin in healthy Japanese

Scientific Title

Effects of consumption of the test food on skin in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on skin in healthy Japanese

Region

Japan

Condition

Healthy Japanese

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of consumption of the test food on skin in healthy Japanese.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measured value of the transepidermal water loss at 12 weeks after consumption (12w)

Key secondary outcomes

1. The amount and rate of change of the transepidermal water loss between screening (before consumption; Scr) and 12w

2. The measured value of the transepidermal water loss at eight weeks after consumption (8w), and the amount and rate of change of it from Scr

3. The measured values of the moisture of the skin, viscoelasticity of the skin, and cheek blood flow at 8w and 12w, and the amount and rate of changes of them from Scr

4. The measured values of original questionnaire ("I feel my skin lacks moisture", "I feel my skin is stiff", "I feel my skin texture is rough", "I feel sagging of the skin", "I feel my skin has no firmness", "I feel my skin has less elasticity", "I feel wrinkles on my face are noticeable", "I feel my skin tone is dark", "I feel cold", and "I feel like my face swells easily") at 8w and 12w

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test food: Active food 1

Interventions/Control_2

Duration: 12 weeks
Test food: Active food 2

Interventions/Control_3

Duration: 12 weeks
Test food: Placebo food

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals whose the transepidermal water loss is relatively high at screening (before consumption) among those who meet inclusion criteria No.1~4 without meeting any of exclusion criteria

Key exclusion criteria

1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Individuals currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. Individuals who are taking medications (including herbal medicines) and supplements

6. Individuals who are allergic to medicines and/or the test food related products

7. Individuals who engage in occupations involving outdoor work

8. Individuals who plan to take trips that will expose them to a lot of sunlight, such as swimming in the sea during this study

9. Individuals who have been diagnosed with atopic dermatitis

10. Individuals who use any products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, skin lotions such as face masks, milky lotions, and sunscreen for daily skincare

11. Individuals who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device)

12. Individuals who have undergone cosmetic surgery

13. Individuals who take grapes, wine, grape juice, or foods/beverages with rich polyphenol (such as cacao, citrus fruit, or black tea) on a daily basis

14. Individuals who are pregnant, lactating, or planning to become pregnant during this study

15. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study

16. Individuals who are judged as ineligible to participate in this study by the physician

Target sample size

30

Name of lead principal investigator

1st name	Tatsuya
Middle name
Last name	Izumi

Organization

Hiroo Dermatology Clinic & Mentors inc.

Division name

Director

Zip code

150-0012

Address

1&2F Hiroo Masugi Annex Bldg., 5-25-5, Hiroo, Shibuya-ku, Tokyo, Japan

TEL

03-5795-1112

Email

dr_izumi@orthomedico.jp

Name of contact person

1st name	Naoko
Middle name
Last name	Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

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

NOF CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Hiroo Dermatology Clinic & Mentors inc.

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

広尾皮フ科クリニック (東京都)
Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan)

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)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2023

Year

10

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

36

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

2023

Year

10

Month

18

Day

Date of IRB

2023

Year

10

Month

18

Day

Anticipated trial start date

2023

Year

10

Month

27

Day

Last follow-up date

2024

Year

03

Month

15

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

10

Month

27

Day

Last modified on

2024

Year

06

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060057