A Study on the Effect of Food Containing Plant Extract on Skin Conditions -A Randomized, Double-blind, Placebo controlled, Parallel-group Study-

UMIN ID: UMIN000056595

Registered date:06/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: No
• Date of first enrollment: 2025/01/07
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Food containing plant extract, 12 weeks consumption
Food not containing plant extract, 12 weeks consumption

Outcome(s)

• Primary Outcome: Transepidermal water loss of scalp after 12 weeks of intake
• Secondary Outcome: Firmness of scalp after 12 weeks of intake, Questionnaire after 12 weeks of intake

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 64years-old
• Gender: Male and Female
• Exclude criteria: Subjects(who) 1)regularly use medications affecting skin. 2)with skin disease, such as atopic dermatitis or with strange skin conditions at measurement points. 3)with severe hay fever symptoms and had been allergic symptoms. 4)have any food allergies. 5)contract or are under treatment for serious diseases (eg, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, vascular disorder, and/or metabolic disease). 6)had been conducted or will conduct an cosmetic operation or beauty treatment on the test spot or had been received hormone replacement therapy in the past 6 months. 7)can't avoid direct sunlight exposure, such as sunburn or sports. 8)with alopecia areata or other hair loss disorders (eczema of the head, seborrheic eczema, psoriasis, tinea capitis, or other scalp infections). 9)regularly use wigs or wigs, or who have had or are planning to have hair transplants or hair extension. 10)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting skin. 11)have a history and/or a surgical history of digestive disease affecting digestion and absorption. 12)are pregnant, breastfeed or planning to become pregnant. 13)have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent, habit of drinking not less than 5 days a week, or can't stop drinking from the days before each measurement. 14)are under treatment for or have a history of drug addiction and/or alcoholism. 15)smoke 20 or more cigarettes a day, or cannot quit smoking during from waking to inspection completed. 16)are shiftworker and/or midnight-shift worker. 17)are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. 18)are judged as unsuitable for the current study by the investigator for other reasons.

Related Information

• Primary Sponsor: Miura Clinic, Medical Corporation Kanonkai
• Source(s) of Monetary Support: TOYO SHINYAKU Co., Ltd.