UMIN-CTR Clinical Trial

Public title

A verification study of the effects of consumption of the test food on improving skin moisture

Acronym

A verification study of the effects of consumption of the test food on improving skin moisture

Scientific Title

A verification study of the effects of consumption of the test food on improving skin moisture: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

A verification study of the effects of consumption of the test food on improving skin moisture

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 improving skin moisture.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measured value of transepidermal water loss (TEWL) at eight weeks after consumption (8w)

Key secondary outcomes

1. The measured value of TEWL at four weeks after consumption (4w)

2. The measured values of viscoelasticity of skin (R0~R9) at 4w and 8w

3. The measured values of moisture content of skin surface at 4w and 8w

4. The measured values of "my skin is glowing," "my skin is less prone to rough," "my skin is resilient," "my skin condition is good," "pores are less visible," "my skin is fine," "my skin tone is lighter," "spots are less noticeable," "my skin has firmness," and "my skin has no dullness" at 4w and 8w

5. The measured values of biological antioxidant potential (BAP), diacron-reactive oxygen metabolite (d-ROMs), and superoxide dismutase (SOD) at 4w and 8w

6. The measured values of erythropoietin at 4w and 8w

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Duration: Eight weeks
Test food: Sea buckthorn juice
Administration: Take 30 mL daily after breakfast, diluted 3~4 times with water because of its strong acidity.

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Interventions/Control_2

Duration: Eight weeks
Test food: Placebo beverage
Administration: Take 30 mL daily after breakfast, diluted 3~4 times with water because of its strong acidity.

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next 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

30

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Individuals aged 30 or more and less than 60

4. Healthy individuals

5. Individuals whose TEWL is 15.1 g/h/m² or more at screening (before consumption)

Key exclusion criteria

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

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

3. are 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. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. are taking or using medications (including herbal medicines) and supplements

6. are allergic to medicines and foods related to the test products, particularly who show allergic reactions to peach, apple, orange, milk, or soybean

7. are pregnant, lactating, or planning to become pregnant during this study

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

9. have been diagnosed with atopic dermatitis

10. habitually receive skincare treatment (such as aesthetic treatment) or use instruments for beauty treatment (such as facial treatment device)

11. have undergone cosmetic surgery

12. usually take food/beverage containing functional ingredients which may influence skin (such as gamma-aminobutyric acid (GABA), isoflavones, lactic acid bacteria, bifidobacteria, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), astaxanthin, glucosylceramide, proteoglycans, piceatannol, lycoperosides, collagen peptide)

13. usually drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: about 1.5 glasses of wine, 90 mL: half-go of shochu, 60 mL: a glass of whiskey brandy (double)}

14. are judged as ineligible to participate in this study by the physician

Target sample size

52

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

Finess Co., Ltd.

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

2024

Year

08

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

56

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

2024

Year

08

Month

07

Day

Date of IRB

2024

Year

08

Month

07

Day

Anticipated trial start date

2024

Year

08

Month

27

Day

Last follow-up date

2025

Year

01

Month

23

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

08

Month

27

Day

Last modified on

2025

Year

05

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063255