Effects of a dairy ingredient on skin condition in healthy subjects: a randomized, double-blind, placebo-controlled trial.

UMIN ID: UMIN000052879

Registered date:23/11/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: None (Healthy subjects)
• Date of first enrollment: 2023/11/24
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ingestion of dairy ingredient for 12 weeks.
Ingestion of placebo for 12 weeks.

Outcome(s)

• Primary Outcome: Index for skin conditions (Skin moisture content, Transepidermal water loss)
• Secondary Outcome: Feeling of dry skin.

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 59years-old
• Gender: Female
• Exclude criteria: 1)Subjects having a milk allergy. 2)Subjects whose lifestyle or living environment is possibly to change significantly during the study. 3)Subjects whose bedtime and/or waking time may change significantly during the study. 4)Subjects who are receiving invasive medical treatments or spa treatments impacting measured skin locations. 5)Subjects who have participated in other clinical trials within the past 3 months. 6)Subjects who are pregnant or under lactation, or who is expected to be pregnant during the study. 7)Subjects who have serious disease in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, metabolic system, or have chronic disease etc. Or those who have serious medical history of these. 8)Subjects who have skin diseases, mental illness, a sleep disorder, or a medical history. 9)Subjects who needs to be on medication for allergic diseases such as pollinosis. 10)Smokers. 11)Extremely heavy drinkers (more than 60g/day of alcohol). 12)Subjects who use medicines or who habitually consume health-promoting foods. 13)Subjects who plan to engage in activities that affect skin condition at measured sites during the study. 14)Others who have been determined as ineligible for the research subject of this study, judging from the principal researcher/doctor's opinions on the findings of their background etc.

Related Information

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