None listed
Conditions
Interventions
Oral intake of the test product (3 pills in a day
4 weeks).
Oral intake of the placebo product (3 pills in a day
4 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Japanese males and females aged 30-64 years [2]Individuals who are healthy and are not suffered from a chronic malady including skin disease. [3] Individuals with physical fatigue in daily life. [4] Individuals with stiff shoulders, back pain, or eye strain due to fatigue in daily life. [5] Individuals who work five days a week during the daytime and have weekends off; who are full-time housewives but their cohabitants work five days a week during the day or commute to school or work on weekdays, and have a regular lifestyle. [6] Individuals whose written informed consent has been obtained. [7] Individuals who can come to the designated venue for this study and be inspected. [8] Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1] Persons with chronic fatigue. [2] Individuals with no physical fatigue in daily life. [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 a drug to treat a disease in the past 1 month. [6] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [7] Individuals who are a patient or have a history of or endocrine disease. [8] Individuals whose BMI is over 30 kg/m2. [9] Individuals with serious anemia. [10] Individuals who are sensitive to test product or other foods, and medical products. [11] Individuals who are a patient of alcohol dependent syndrome or excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [12] Individuals with possible changes of life style during the test period. [13] Individuals who have and had a habit to ingest food with functional claims, health foods, or supplements in the past 3 months or will ingest those foods during the test period (excepting individuals who can suspend ingest for the test period at obtaining informed consent). [14] Individuals who have a habit of consuming foodstuffs related to the test food with high frequency on a daily basis. [15] Individuals who are or are possibly pregnant, or are lactating. [16]Individuals who participated in other clinical studies in the past 3 months. [17] Individuals who are or whose family is engaged in healthy or functional foods. [18]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Physical Fatigue-Related Surveys [2]Antioxidant indexes | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed