4-week continuous skin and intestinal environmental improvement test of oligolactic acid and placebo products

UMIN ID: UMIN000045485

Registered date:14/09/2021

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 2021/09/16
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Take 1 cup of test food with water(when you like)for 4 weeks.
Take 1 cup of test food with water(when you like)for 4 weeks.

Outcome(s)

• Primary Outcome: Defecation frequency Percutaneous water evaporation
• Secondary Outcome: Property of stool Feeling during defecation Volume of stool Gut microbiota Horny water content Amount of sebum Sebum flexibility Sebum elasticity Hydrogen ion index Multiple peeling Wrinkle analysis using replica images Pore analysis using replica images Texture analysis using replica images Visual dullness evaluation Visual spot evaluation Visual evaluation of redness Visual evaluation of acne Visual evaluation of pore Visual evaluation of blackheads in the pores Visual evaluation of roughness of texture Visual evaluation of wrinkle Visual evaluation of rough skin Visual evaluation of appearance tension Visual evaluation of clarity

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 59years-old
• Gender: Male and Female
• Exclude criteria: 1)Those suffering from skin diseases such as psoriasis 2)Those suffering from skin diseases such as atopic dermatitis 3)Those suffering from skin diseases such as atopic dermatitis 4)Those who are taking or applying medications that may affect the test results 5)Those who have contact allergies or may show allergic symptoms 6)Those who currently attend dermatology 7)Those who have eczema, rash, sunburn, spots, scratch marks etc. at the test site 8)Pregnant or likely to be breastfeeding 9)Those with irregular lifestyle 10)Those who drink more than 20 grams of alcohol per day 11)Those who have smoking habits 12)Those who smoke more than 21 cigarettes per day 13)Those who use pharmaceuticals foods for specific health foods and other health foods 14)Those who cannot refrain from consuming food in certain health uses, functionally labeled foods, or so-called health foods during the inspection period 15)Those who cannot take test food as instructed 16)Those who have unders been subjected to chemical peel, laser treatment, light irradiation treatment, skin injection treatment or surgical treatment, etc. at the test site within 4 weeks prior to the start date of the test, or who have unders been subjected to esthetic treatment. 17)Those who are judged by the person in charge of test implementation tobe inappropriate for participating in the test.

Related Information

• Primary Sponsor: Mibyou Life Science Inc. Clinical Trial Division
• Source(s) of Monetary Support: GLART INC.