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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000050826

Enrollment

Registered

2023-04-13

Start date

2023-04-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Oral intake of the test substance 1 (10g

single dose). Test substance 2 not ingested (Direct exposure to skin fibroblasts). Test substance 3 not ingested (Direct exposure to skin fibroblasts). Test substance 4 not ingested (Direct exposure s

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.)	—

Secondary

Measure	Time frame
*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.)	—

Countries

Japan

Contacts

Public ContactRyoma Shimizu

TES Holdings Co., Ltd. Administrative Department of Clinical Trials

r.shimizu@tes-h.co.jp+81-3-6801-8480

Outcome results