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A study to evaluate skin moisture levels

A study to evaluate the effect of the test food consumption on skin barrier function: a randomized, placebo-controlled, double-blind, parallel-group comparison study - A study to evaluate the effect of the test food consumption on skin barrier function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057384
Enrollment
56
Registered
2025-03-24
Start date
2025-03-24
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Healthy Japanese

Interventions

Duration: 12 weeks Test product: The test food Duration: 12 weeks Test product: The placebo food

Sponsors

ENSUIKO SUGAR REFINING CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose TEWL is high at screening

Exclusion criteria

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) or supplements 6. usually take medicines, health foods, "Foods for Specified Health Uses," or "Foods with Functional Claims," that may affect bowel movement / take foods fortified with ingredients affecting bowel movement (e.g., fermented foods such as natto, kimchi, and pickles and foods fortified with dietary fiber) 7. plan to take trips that will expose them to a lot of sunlight, such as swimming in the sea during this study 8. have been diagnosed with atopic dermatitis 9. use any products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, skin lotions such as face masks, milky lotions, and sunscreen for daily skincare 10. habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 11. have undergone cosmetic surgery 12. are allergic to medicines and foods related to the test product 13. have lactose intolerance 14. are pregnant, lactating, or planning to become pregnant during this study 15. 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 16. are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

MeasureTime frame
1. The measured value of transepidermal water loss (TEWL) at 12 weeks after intervention (12w)

Secondary

MeasureTime frame
1. The measured value of moisture content of skin surface at 12w

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026