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

UMIN ID: UMIN000055563

Registered date:22/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: No
• Date of first enrollment: 2024/10/08
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 one time a day for 8 weeks).

Outcome(s)

• Primary Outcome: AGEs score (Week 0, Week 4, Week 8)
• Secondary Outcome: * 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

Key inclusion & exclusion criteria

• Age minimum: 35years-old
• Age maximum: 55years-old
• Gender: Female
• Exclude 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.

Related Information

• Primary Sponsor: TES Holdings Co., Ltd.
• Source(s) of Monetary Support: Morinaga Milk Industry Co., Ltd.