Study of the effects of test food intake on skin function and intestinal microflora

UMIN ID: UMIN000055488

Registered date:11/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: No
• Date of first enrollment: 2024/09/25
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Oral intake of the test food (Dissolve 1 packet per day in about 100mL of water and consume; 8 weeks).
Oral intake of the placebo food (Dissolve 1 packet per day in about 100mL of water and consume; 8 weeks).

Outcome(s)

• Primary Outcome: Skin Physical and Chemical Examination (Week 0, Week 8)
• Secondary Outcome: *Secondary indexes 1) Intestinal Microflora Analysis (Week 0, Week 8) 2) Observation for skin condition by dermatologists (Week 0, Week 8) 3) Visual Analogue Scale (Week 0, Week 8) *Safety 1) Blood pressure, pulsation (Week 0, Week 8) 2) Weight, body fat percentage, BMI (Week 0, Week 8) 3) Doctor's questions (Week 0, Week 8) 4) Subject's diary (From the first day of ingestion of a test material to the last day of the test)

Key inclusion & exclusion criteria

• Age minimum: 35years-old
• Age maximum: 65years-old
• Gender: Female
• Exclude criteria: 1) Individuals using medical products. 2) Individuals who have been diagnosed and are under treatment for functional constipation at a medical institution. 3) Individuals who are determined to have chronic constipation in the diagnostic criteria for chronic constipation. 4) Individuals undergoing hormone replacement procedures. 5) Individuals with skin disease symptoms such as atopic dermatitis. 6) Individuals with wounds or inflammation at the site of evaluation. 7) Individuals who used a drug to treat a disease in the past 1 month. 8) Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. 9) Individuals who are a patient or have a history of or endocrine disease. 10) Individuals with mental disabilities. 11) Individuals whose BMI is over 30 kg/m2. 12) Individuals who are sensitive to test product or other foods, and medical products. 13) Individuals who have been continuously using lactobacillus-enriched foods, foods for specified health uses, foods with functional claims, or health foods that improve skin and bowel movements at present or within the past three months. 14) Individuals who excessively take alcohol. 15) Individuals who are a smoker. 16) Individuals who engage in a night work. 17) Individuals with possible changes of life style during the test period. 18) Individuals who are at risk of developing hay fever or other seasonal allergic symptoms during the study period and may take pharmaceutical medication or use nasal drops. 19) Individuals who will get sunburned during the test period. 20) Individuals who neglect skin care. 21) Individuals with a history of cosmetic treatment or treatment for the evaluation area. 22) Individuals who are or are possibly pregnant, or are lactating. 23) Individuals who participated in other clinical studies in the past 3 months. 24) Individuals judged inappropriate for the study by the principal.

Related Information

• Primary Sponsor: TES Holdings Co., Ltd.
• Source(s) of Monetary Support: Fuji Nihon Seito Corporation