Healthy subjects
Conditions
Interventions
Continuous intake of the test food for 5 weeks
Continuous intake of control foods for 5 weeks
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese males and females who are between 30 and 59 years of age at the time of written informed consent. 2.Subjects with Fitzpatrick skin phototype II or III (a skin phototype characterized by burning and then tanning after sunbathing for 30 to 45 minutes during the spring or summer). 3.Subjects who are fully informed of the purpose and details of the study, capable of giving informed consent, and volunteering to participate in the study based on a full understanding of it, and who have given written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Subjects diagnosed with photosensitivity by a physician. 2.Subjects receiving medication or outpatient treatment for a serious disease. 3.Subjects receiving exercise or diet therapy under the supervision of a physician. 4.Subjects who maybe for allergic reactions to the material of the test food. 5.Subjects with current or previous history of drug dependence or alcohol dependence. 6.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder (e.g., insomnia, sleep apnea syndrome) or have previous history of a psychiatric disorder. 7.Night or shift workers with irregular life patterns. 8.Subjects whose eating, sleeping, and other habits are extremely irregular. 9.Subjects who are having a very unbalanced diet. 10.Subjects with current or previous history of a brain disease, malignancy, immunological disease, diabetes mellitus, hepatic disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, metabolic disease, or other serious diseases. 11.Subjects who use for the site of UV irradiation (the back) or take an anti-inflammatory agent for the skin (topical or oral agent) once a month or more frequently. 12.Subjects who have any factors on the skin of the site of UV irradiation (the back) that may affect the results of the study (disorders such as atopic dermatitis and urticaria, inflammation, eczema, traumatic injury, acne, pimple, wart, spot, tattoo, or other similar conditions or scars of such conditions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal Erythema Dose | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) L* value (at the site irradiated with 1.5 MED as well as the difference between the non-irradiated site and the site irradiated with 1.5 MED), amount of melanin (at the site irradiated with 1.5 MED as well as the difference between the non-irradiated site and the site irradiated with 1.5 MED) (Safety endpoints) Vital signs, physical measurements(body weight and BMI),adverse events | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed