Healthy subjects
Conditions
Interventions
Continuous ingestion of the test food 1 for 12 weeks
Continuous ingestion of the test food 2 for 12 weeks
Continuous ingestion of the test food 3 for 12 weeks
Continuous ingestion of the placebo
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Japanese females who are aged 45 years or older and younger than 65 years at the time of written informed consent. 2.Subjects whose BMI is 21 kg/m2 or more and less than 30 kg/m2. 3.Subjects who feel they have dry skin. 4.Non-smokers. 5.Subjects whose mean alcohol consumption of less than 30 g per day (as an average of one week). 6.Subjects who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1.Subjects receiving medication or outpatient treatment for a serious disease. 2.Subjects receiving exercise or diet therapy under the supervision of a physician. 3.Subjects who maybe for allergic reactions to the material of the test food (dietary ingredient). 4.Subjects with current or previous history of drug dependence or alcohol dependence. 5.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. 6.Subjects with symptoms of serious skin diseases such as atopic dermatitis. 7.Night or shift workers with extremely irregular life patterns. 8.Subjects doing physical work for 10 hours or more per week. 9.Subjects whose eating, sleeping, and other habits are extremely irregular. 10.Subjects who are having a very unbalanced diet. 11.Subjects doing exercise to maintain or improve strength for 30 minutes or more twice a week. 12.Subjects whose body weight increased or decreased by 5 kg or more in the last 2 months. 13.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. 14.Subjects who take products that impact antioxidant capacity such as health foods, supplements, and drugs (e.g., vitamins E and C, astaxanthin, beta-carotene, sesamin) three or more days a week. 15.Subjects who take edible oils intended to maintain and improve health (e.g., MCT, flaxseed oil, perilla oil, EPA, DHA, olive oil) three or more days a week. 16.Subjects who are unable to stop intentional exposure to direct sunlight such as tanning. 17.Subjects who routinely care for their skin using methods for cosmetic purposes such as facial equipment and esthetic salon treatments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Index of skin instrumental analysis (transepidermal water loss [TEWL], stratum corneum water content, viscoelasticity) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Index of skin questionnaire (Visual Analog Scale), index of fatigue questionnaire (Visual Analog Scale), index of mood states questionnaire (POMS 2-A short), arterial stiffness (brachial-ankle pulse wave velocity), blood fatty acid concentrations, blood lipid levels, index of skin instrumental analysis (texture) (Safety evaluation) 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