Effects of consumption of the Mallotus japonicus leaf extract powder on skin in healthy Japanese subjects

UMIN ID: UMIN000051165

Registered date:16/09/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy Japanese subjects
• Date of first enrollment: 2023/05/25
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: Eight weeks Test food: Capsule containing Mallotus japonicus leaf extract powder Administration: Take one capsule per day after breakfast with water *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: Eight weeks Test food: Capsule containing excipients Administration: Take one capsule per day after breakfast with water *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Outcome(s)

• Primary Outcome: 1. The moisture of the skin, transepidermal water loss, and viscoelasticity of the skin
• Secondary Outcome: 1. The score of advanced glycation end products (AGEs), oxidative stress, blood flow volume, and original questionnaires

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who are currently using medications or other products that may affect the skin, such as medicinal lotions 10. Subjects who take foods or supplements that may affect the skin, such as procyanidins, sodium hyaluronate, or glucosylceramide 11. Subjects who regularly take supplements with rich ellagitannins such as pomegranate, guava, and "Ten-Cha" (sweet Chinese tea) 12. Subjects who take foods or supplements that may affect blood flow, such as elastin, chlorogenic acid 13. Subjects who engage in occupations involving outdoor work 14. Subjects who plan to take trips that will expose them to a lot of sunlight, such as swimming in the sea during this trial 15. Subjects who are judged as ineligible to participate in this study by the physician

Related Information

• Primary Sponsor: ORTHOMEDICO Inc.
• Secondary Sponsor: Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
• Source(s) of Monetary Support: ORTHOMEDICO Inc.,API CO.,LTD.