Verification test of improvements in skin condition by intake of amla extract and fish collagen peptide.

UMIN ID: UMIN000034932

Registered date:01/12/2018

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy female
• Date of first enrollment: 2018/12/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Ingestion of test food containing amla extract and collagen peptide in 8 weeks.

Outcome(s)

• Primary Outcome: Collagen density in derma (0w, 8w)
• Secondary Outcome: Moisture content of the stratum corneum (0w, 8w). The image analysis of the skin surface (0w, 8w). Oxidative stress markers (8-OHdG and IPs) (0w, 8w). Urine metabolite (0w, 8w). Glycation markers (0w, 8w). Improvement of symptoms (0w, 4w, 8w).

Key inclusion & exclusion criteria

• Age minimum: 32years-old
• Age maximum: 58years-old
• Gender: Female
• Exclude criteria: (1)Subjects with allergies to raw materials for test foods. (2)Subjects who take healthy foods obtaine amla extract and fish collagen peptide. (3)Subjects who routinely take healthy foods. (4)Subjects who has a factor (diseases such as atopic dermatitis and hives, inflammation, eczema, trauma, breakouts, warts, blemishes, etc. or traces) influencing the test at evaluation site. (5)Subjects with experience in cosmetic medicine (Botox injections, hyaluronic acid, collagen infusion, photofacial, etc.) at the evaluation site or who are expected to undergo the test period. (6)Subjects who has received a special skin care treatment (beauty salon, esthetic, etc.) for the evaluation site within the past four weeks or is expected to undergo during the examination period. (7)Subjects who changed the basic cosmetics and sunscreen material used for the evaluation site within the past four weeks, or newly started using it. (8)Night Shift and day and night shift workers. (9)Subjects who has received a treatment (hormone replacement therapy, drug therapy, exercise therapy, diet, etc.) at a medical institution for the treatment or prevention of disease and is deemed to be in need of treatment at the time of consent acquisition. (10)Glucose metabolism, lipid metabolism, liver function, renal function, heart, cardiovascular, respiratory tract, endocrine system, immune system, subjects with a history of serious diseases or psychiatric disorders of the nervous system. (11)subjects who has dependence of drug and alcohol. (12)Subjects with allergies to cosmetics or foods. (13)Pregnant women, those who may be pregnant, lactating women, or women who hope to become pregnant during the study period. (14)Subjects who has participated in other human studies within the past four weeks, or subjects who plan to participate in other human studies during the planned period of the study. (15)Subjects who were considered inappropriate for the study by an investigator.

Related Information

• Primary Sponsor: Miki Corporation
• Source(s) of Monetary Support: Miki Corporation