UMIN-ICDS Clinical Trial

Public title

Gene expression evaluation test in skin fibroblasts using human blood metabolites ~ex vivo test~

Acronym

Gene expression evaluation test in skin fibroblasts using human blood metabolites ~ex vivo test~

Scientific Title

Gene expression evaluation test in skin fibroblasts using human blood metabolites ~ex vivo test~

Scientific Title:Acronym

Gene expression evaluation test in skin fibroblasts using human blood metabolites ~ex vivo test~

Region

Japan

Condition

No

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Serum obtained after oral intake of test substance 1 is exposed to skin fibroblasts to evaluate gene expression. A similar evaluation is also performed after direct exposure of test substances 2,3,4 to skin fibroblasts.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Evaluation of gene expression related to moisturizing, elasticity and barrier function of human skin
(Before and 30,60 minutes after ingestion of the test food.)

Key secondary outcomes

*Safety
[1]Hematologic test
(Before and 30,60,90,180 minutes after ingestion of the test food.)
[2]Blood biochemical test
(Before and 30,60,90,180 minutes after ingestion of the test food.)

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Oral intake of the test substance 1 (10g; single dose).

Interventions/Control_2

Test substance 2 not ingested (Direct exposure to skin fibroblasts).

Interventions/Control_3

Test substance 3 not ingested (Direct exposure to skin fibroblasts).

Interventions/Control_4

Test substance 4 not ingested (Direct exposure skin fibroblasts).

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

25

years-old

<=

Age-upper limit

50

years-old

>

Gender

Male and Female

Key inclusion criteria

[1] Japanese males and females aged 25-49 years.
[2] Individuals whose written informed consent has been obtained.

Key exclusion criteria

[1] Individuals who used a drug to treat a disease in the past 1 month.
[2] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[3] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[4] Individuals who are a patient or have a history of or endocrine disease.
[5] Individuals with serious anemia.
[6] Individuals whose BMI is less than 18.5kg/m2 and over 25.0kg/m2.
[7] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[8] Individuals who have a habit of continuous intake of functional foods, health foods, supplements in the past 1 month, and who plan to consume such foods during the test period.
[9] Individuals who experienced unpleasant feeling during blood drawing.
[10] Individuals with drug and food allergies.
[11] Individuals who are a smoker or have quit smoking for less than 6 months.
[12] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day).
[13] Individuals who participated in other clinical studies in the past 1 month.
[14] Individuals judged inappropriate for the study by the principal.

Target sample size

3

Name of lead principal investigator

1st name	Atsushi
Middle name
Last name	Nakajima

Organization

Ueno-Asagao Clinic

Division name

Head

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6240-1162

Email

info@ueno-asagao.clinic

Name of contact person

1st name	Ryoma
Middle name
Last name	Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

RIKEN VITAMIN CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ueno-Asagao Clinic Ethical Review Committee

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

Tel

+81-3-6240-1162

Email

jimukyoku@tes-h.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

2023

Year

04

Month

13

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

2023

Year

03

Month

30

Day

Date of IRB

2023

Year

04

Month

11

Day

Anticipated trial start date

2023

Year

04

Month

14

Day

Last follow-up date

2023

Year

04

Month

21

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

04

Month

12

Day

Last modified on

2023

Year

10

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057906