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Effects of a test food for improvement of skin-related indices: a randomized, double-blind, placebo-controlled trial

Effects of a test food for improvement of skin-related indices: a randomized, double-blind, placebo-controlled trial - Effects of a test food for improvement of skin-related indices: a randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055563
Enrollment
120
Registered
2024-09-22
Start date
2024-10-08
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 food (Dissolve 1 packet in 100-150mL of water and intaking one time a day for 8 weeks). Oral intake of the placebo food (Dissolve 1 packet in 100-150mL of water and intaking on

Sponsors

TES Holdings Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Healthy Japanese females aged 35-54 years. 2) Individuals who are healthy and have no chronic disease including skin disease. 3) Individuals who are aware of or concerned about dullness of their skin.

Exclusion criteria

Exclusion criteria: 1) Individuals who have a past or present history of serious illness. 2) Individuals who have wounds or inflammation in the evaluation site. 3) Individuals who are sensitive to the test food. 4) Individuals who have had a habit of continuously ingesting drugs, quasi-drugs, health functional foods, health foods, or supplements that claim whitening/skin improvement effects within 3 months before the start of the test, or who plan to use them during the test period. 5) Individuals who have used cosmetics that claim whitening effects within 3 months before the start of the test, or who plan to use them during the test period. 6) Individuals who are or are possibly pregnant, or are lactating. 7) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). 8) Individuals who are a smoker. 9) Individuals with possible changes of life style during the test period. 10) Individuals who will develop seasonal allergy symptoms like hay fever and be to suffer from worsening eyes and nose symptoms or use anti-allergic drugs during the test period. 11) Individuals who will get sunburned during the test period. 12) Individuals who had been conducted an operation or beauty treatment on the evaluation area within 6 months before the start of the test. 13) Individuals who participated in other clinical studies in the past 3 months. 14) Individuals judged inappropriate for the study by the principal.

Design outcomes

Primary

MeasureTime frame
AGEs score (Week 0, Week 4, Week 8)

Secondary

MeasureTime frame
* Secondary indexes 1) Visual Analogue Scale(1) 2) Skin color ( Color-difference measurement ) (1) 3) Image analysis by VISIA(1) 4) Observation for skin condition by dermatologists (Texture, Skin quality) (1) 5) The Japanese version of the Pittsburgh Sleep Quality Index(1) *Other 1) Adverse events and side effects(2) (1): Week 0, Week 4, Week 8 (2): During the test period

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

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026