Efficacy evaluation of a food ingredient to skin condition in healthy adults -Randomized, double-blind, placebo-controlled, parallel-group study-

UMIN ID: UMIN000056126

Registered date:13/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: None
• Date of first enrollment: 2024/11/13
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intakes of test capsules for 8 weeks
Intakes of placebo capsules for 8 weeks

Outcome(s)

• Primary Outcome: skin moisture
• Secondary Outcome: Evaluation of skin condition Blood biochemical analysis

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: Subjects 1.who have some diseases with drug therapy. 2.who consecutively receive medications in the last 1 month. 3.who have severe disease histories in liver or the other tissues. 4.who have a comorbidity or disease history in respiratory system. 5.Systolic and diastolic blood pressures are over 160 mmHg and 100 mmHg, respectively. 6.who have donated over 200 or 400 mL of blood in the last 1 or 3 months. 7.who have severe anemia. 8.who could have some allergy to the test diet. 9.who are pregnant, breastfeeding, or planning to be pregnant in the near future. 10.who are alcoholic or have mental disorder. 11.who have a smoking habit. 12.who have irregular defecation. 13.who could change their life style during the study. 14.whose skin is extremely sensitive, or who have chronic ruddy complexion, outstanding pores or freckles. 15.who have some skin diseases. 16.who could have a seasonal allergy. 17.who have severe menopausal symptoms. 18.who have severe poor circulation. 19.who habitually shave their face with a razor blade. 20.who are willing to get sunburn, spend long time outdoors, during the study. 21.who habitually intake functional foods that could get skin condition better in the last 3 months. 22.who habitually consume cosmetics or foods made of microbes. 23.who routinely use pharmaceuticals that could get skin condition better. 24.who use cosmetics that could have strong effects on skin moisture or wrinkles. 25.who received a surgery on their faces or arms in the last 6 months. 26.who participated in other clinical trials in the last 3 months. 27.who and whose family work for a company manufacturing or selling healthy foods, functional foods or cosmetics. 28.who have a weakened immune system. 29.who refuse to disclose their biological sex. 30.who are judged unsuitable for this study by the investigator for other reasons.

Related Information

• Primary Sponsor: TES Holdings Co., Ltd
• Source(s) of Monetary Support: Kirin Holdings Company, Limited