N/A (healthy adults)
Conditions
Interventions
Oral intake of healthy meals (two times in a day [eating for breakfast and lunch or dinner
four weeks [from every Monday to Friday).
Oral intake of normal meals (keeping habit of eating before participating with the study
four weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [1]Healthy Japanese males and females aged 20-65 years. [2]Individuals whose BMI is more than 25.0 kg 2 and less than 30.0 Kg 2. [3]Individuals who anxious about skin dryness, sag, and tone. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can visit an inspection facility and be inspected in designated days. [6]Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals who cannot continue to eat a test meal for 4 weeks. [2]Individuals who are in constipation. [3]Individuals using medical products. [4]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [5]Individuals who used or applied a drug for treatment of disease in the past 1 month. [6]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [7]Individuals who contract or have a history of serious endocrine disease. [8]Individuals who recorded weight gain and loss (+-2 kg) in the past 1 month. [9]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [10]Individuals who are sensitive to test product or other foods, and medical products. [11]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [12]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [13]Individuals who will develop seasonal allergy symptoms like hay fever and a drug. [14]Individuals who neglect skin care. [15]Individuals who cannot avoid daylight exposure during the test period. [16]Individuals who had been conducted an operation or beauty treatment on the test spot. [17]Individuals who had a habit to ingest health-promoting foods, or supplements in the past 3 months or will ingest those foods during the test period. [18]Individuals who are or are possibly, or are lactating. [19]Individuals who participated in other clinical studies in the past 3 months. [20]Individuals who are or whose family is engaged in health foods of functional foods. [21]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Indexes for body fat(1), skin properties(1) and QOL(2). (1):Screening, Week 0, Week 4. (1):Week 0, Week 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1]Specific blood test(1). [2]Specific urinary test(1). [3]Specific saliva test(1). [4]Specific fecal test(1). [5]Specific exhalation test(1). *Safety [1]Blood pressure, pulsation(2). [2]Hematologic test(2). [3]Blood biochemical test(2). [4]Urine analysis(2). [5]Subject's diary(3). [6]Doctor's questions(2). [7]Side effects and adverse events(1). (1):Week 0, Week 4. (2):Screening, Week 0, Week 4. (3):From the first day of ingestion of a test material to the last day of the test. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed