NIPH Clinical Trials Search

UMIN ID: UMIN000052879

Registered date:23/11/2023

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

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedNone (Healthy subjects)
Date of first enrollment2023/11/24
Target sample size80
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Ingestion of dairy ingredient for 12 weeks. Ingestion of placebo for 12 weeks.


Primary OutcomeIndex for skin conditions (Skin moisture content, Transepidermal water loss)
Secondary OutcomeFeeling of dry skin.

Key inclusion & exclusion criteria

Age minimum30years-old
Age maximum59years-old
Include criteria
Exclude criteria1)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


public contact
Name Miwa Kaneko
Address 3F Daiwa A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo Japan 105-0013
Telephone 03-5408-1555
Affiliation SOUKEN Co., Ltd. Secretariat
scientific contact
Name Takashi Koikeda
Address 6F Daiwa A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo Japan
Telephone 03-5408-1599
Affiliation Shiba Palace Clinic Hospital director