UMIN-ICDS Clinical Trial

Public title

Verification of the effects of test food intake on skin moisturization in healthy adults

Acronym

Verification of the effects of test food intake on skin moisturization in healthy adults

Scientific Title

Verification of the effects of test food intake on skin moisturization in healthy adults
: Placebo-controlled, double-blind, randomized, parallel-group comparison study

Scientific Title:Acronym

Verification of the effects of test food intake on skin moisturization in healthy adults
: Placebo-controlled, double-blind, randomized, parallel-group comparison study

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Examining the effects of research food intake on skin moisturization

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Stratum corneum water content

Key secondary outcomes

Visual Analogue Scale

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

Ingestion of research food for 8 weeks

Interventions/Control_2

Ingestion of placebo food 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

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Subjects of men and women aged 20 to 64
(2) Subject suffering from dry skin
(3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing

Key exclusion criteria

(1)Subjects with skin diseases (e.g. atopic dermatitis)
(2)Subjects with diabetes mellitus, liver disease, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, disease affecting the secretion of adrenal corticosteroids, or other serious diseases, or with pre-existing diseases
(3)Subjects who have undergone gastrointestinal surgery
(4)Subjects with diseases currently being treated, or for whom treatment is deemed necessary by the principal investigator or research assistants
(5)Subjects who are allergic to food (especially gelatin) and drugs
(6)Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects
(7)Subjects who habitually engage in strenuous sports such as marathon running (including professional athletes) and subjects on a diet
(8)Subjects with extremely irregular sleeping habits and eating habits
(9)Subjects who may be exposed to excessive ultraviolet light or daily exposure to sunlight during the study period (Truck driver, etc.)
(10)Subjects who visit beauty salons for skin care
(11)Subjects who are unable to discontinue consumption of health foods (including food for specified health uses, functional foods, and supplements) and designated quasi-drugs during the study period
(12)Subjects who are continuously undergoing any medical treatment (including laser treatment, facelift, skin peel, etc.) related to skin that affect the results of the study or treatment with drugs that affect skin condition (including OTC and prescription drugs; antihistamines, antiallergic agents, topical steroids, hydrating moisturizers, etc.)
(13)Subjects who have a habit of consuming foods high in functional ingredients of the test food

(14) to (20) are listed in the "Other related information" column

Target sample size

100

Name of lead principal investigator

1st name	Naoki
Middle name
Last name	Miura

Organization

Miura Clinic, Medical Corporation Kanonkai

Division name

Internal medicine

Zip code

530-0044

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka

TEL

06-6135-5200

Email

info@miura-cl.jp

Name of contact person

1st name	Makoto
Middle name
Last name	Terashima

Organization

Oneness Support Co., Ltd.

Division name

Clinical Trial Division

Zip code

530-0044

Address

Higashitenma building 6F, 1-7-17, Higashitenma, Kita-ku, Osaka

TEL

06-4801-8917

Homepage URL

Email

mterashima@oneness-sup.co.jp

Institute

Miura Clinic, Medical Corporation Kanonkai

Institute

Department

Personal name

Organization

Kewpie Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Miura Clinic, Medical Corporation Kanonkai IRB

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka

Tel

06-6135-5200

Email

mterashima@miura-cl.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人花音会みうらクリニック（大阪府）　Miura Clinic, Medical Corporation Kanonkai（Osaka）

Date of disclosure of the study information

2024

Year

01

Month

21

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

2023

Year

12

Month

19

Day

Date of IRB

2023

Year

12

Month

21

Day

Anticipated trial start date

2024

Year

02

Month

19

Day

Last follow-up date

2024

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

"Key exclusion sriteria"
(14) Subjects who work day and night shifts or engage in physical labor such as heavy lifting
(15) Subjects with usual symptoms of diarrhea or abdominal pain
(16) Subjects are unable to perform the testing procedures to be conducted during the study period as specified
(17) Subjects who plan to travel abroad during the research period
(18) Subjects who drink more than 20 g of average daily pure alcohol
(19) Subjects who smoke an average of 21 or more cigarettes per day
(20) Subjects who are participating in or will participate in other clinical trials at the start of this study.
(21) Other subjects judged by the investigator or the investigator to be inappropriate for the examination

Registered date

2024

Year

01

Month

11

Day

Last modified on

2024

Year

01

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060829