UMIN-ICDS Clinical Trial

Public title

Evaluation of the Effect of Study Food Consumption on Improvement of Skin Condition

Acronym

Evaluation of the Effect of Study Food Consumption on Improvement of Skin Condition

Scientific Title

Evaluation of the Effect of Study Food Consumption on Improvement of Skin Condition

Scientific Title:Acronym

Evaluation of the Effect of Study Food Consumption on Improvement of Skin Condition

Region

Japan

Condition

Male/female adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of daily consumption of one serving of the test food as a replacement for a staple food per day for 8 weeks on the improvement of skin condition, compared with consumption of the control food.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Skin moisture retention (transepidermal water loss and stratum corneum hydration)

Key secondary outcomes

Skin viscoelasticity
Skin structure analysis
VISIA skin image analysis
Visual Analog Scale (VAS) questionnaire regarding skin condition
Gut bacteriophages
Gut microbiota composition

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

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Oral consumption of one test food once daily for 8 weeks

Interventions/Control_2

Oral consumption of one placebo food once daily for 8 weeks

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Male and female aged 20 to below 65 years at the time of consent acquisition.
2. Individuals with a bowel movement frequency of five times or fewer per week.
3. Individuals who are concerned about dry skin.
4. Individuals who are able to receive the study food once two weeks.
5. Individuals able to consume one unit of the study food per day.
6. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.

Key exclusion criteria

1. Individuals who consume Foods for Specified Health Uses, Foods with Function Claims, or other health foods or supplements more than twice a week.
Individuals who consume such products once a week or less but are unable to discontinue their use from the time of consent acquisition.
2. Individuals who consume yogurt, lactic acid bacteria drinks, or foods high in dietary fiber (e.g., brown rice, barley, whole-grain bread, cereals, and foods bearing nutrient content claim such as "contains dietary fiber" or "high in dietary fiber") a total of three or more times per week.
3. Individuals who consume alcohol more than three times per month or who consume more than 60 g of alcohol per drinking occasion.
4. Individuals who had days with fewer than 1 meal per day more than once a week within 1 month before the preliminary examination.
5. Individuals on carbohydrate-restricted, weight-loss diets or undergoing dietary therapy.
6. Individuals with extremely irregular lifestyles (e.g., night shift workers or those with irregular rotating shifts).
7. Individuals with a BMI of 30.0 kg/m² or higher.
8. Individuals who plan to change their current lifestyle, dietary habits, living environment (e.g., moving, job transfers, overseas travel or business trips), skincare products, or cosmetics during the study period.
9. Individuals who are currently undergoing, or plan to undergo during the study period, procedures or practices that may affect skin condition, including medical treatments, aesthetic treatments, hair removal, chemical peeling, the use of microneedle-containing cosmetic products, or intentional tanning (e.g., use of tanning beds).
10. Individuals who habitually engage in prolonged sun exposure, such as outdoor sports or outdoor work.
11. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.

Target sample size

60

Name of lead principal investigator

1st name	Fumiko
Middle name
Last name	Nakamura

Organization

CPCC Company Limited

Division name

Clinical Support Department

Zip code

103-0021

Address

4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan

TEL

03-6225-9001

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name	Masanori
Middle name
Last name	Numa

Organization

CPCC Company Limited

Division name

Clinical Planning Department

Zip code

103-0021

Address

4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan

TEL

03-6225-9001

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

Nisshin Seifun Group Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan

Tel

03-6225-9005

Email

IRB@cpcc.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

10

Month

19

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

Preinitiation

Date of protocol fixation

2026

Year

06

Month

22

Day

Date of IRB

2026

Year

06

Month

19

Day

Anticipated trial start date

2026

Year

07

Month

23

Day

Last follow-up date

2027

Year

01

Month

12

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Exclusion key criteria continued)
12. Individuals whose cohabiting family members are also scheduled to participate in this study.
13. Individuals with a history of atopic dermatitis or an atopic predisposition.
14. Individuals who are likely to use medications for seasonal allergies during the study period, or who have subjective symptoms of skin irritation associated with allergic symptoms.
15. Individuals with bruises, wounds, or other skin abnormalities at the measurement sites (left side of the face or the inner side of the left forearm).
16. Individuals who have undergone surgeries that could affect the study within six months prior to consent acquisition (e.g., colonoscopy, gallstone or gallbladder removal, or gastric bypass surgery).
17. Individuals who have taken, or plan to take during the study period, medications that may affect the intestinal environment (e.g., antibiotics, probiotics, laxatives, proton pump inhibitors) within one month before the preliminary examination.
18. Individuals using medications at the measurement sites that may affect study outcomes, including heparinoid preparations, urea, petrolatum, or topical steroids.
19. Individuals who have continuously used pharmaceuticals, quasi-drugs, or cosmetic products for the treatment of a disease within 3 months prior to the time of informed consent acquisition (excluding occasional use for headache, menstrual pain, common cold symptoms, or similar conditions).
20. Individuals with a current or past history of serious diseases affecting the cardiovascular, hepatic, renal, or gastrointestinal systems, including a history of appendectomy.
21. Females who are pregnant, breastfeeding, or intending to become pregnant during trial period.
22. Individuals with allergies to pharmaceuticals or foods.
(23-28 have been omitted.)
29. Individuals deemed unsuitable for participation in this trial by the principal investigator or sub-investigator.

Registered date

2026

Year

07

Month

22

Day

Last modified on

2026

Year

07

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070872