N/A(healthy adults)
Conditions
Interventions
Oral ingestion of the test product A
Oral ingestion of the test product B
Oral ingestion of the placebo product
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese males aged 30-64 years. [2]Individuals who are healthy and are not received treatment of disease. [3]Individuals who have daily fatigue. [4]Individuals who have shoulder stiffness, lower back pain, or eyestrain derived from fatigue. [5]Individuals who work on daytime from Monday to Friday and have Saturdays and Sundays off. [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]Individuals who have chronic fatigue. [2]Individuals using medical products. [3]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [4]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [6]Individuals who are a patient or have a history of or endocrine disease. [7]Individuals whose BMI is over 30. [8]Individuals with serious anemia. [9]Individuals who are sensitive to a test product or other foods, and medical products. [10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [11]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [12]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements with components contained in the test product in the past 3 month or will ingest those foods during the test period. [13]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [14]Individuals who are or are possibly, or are lactating. [15]Individuals who participated in other clinical studies in the past 3 months. [16]Individuals who are or whose family is engaged in functional foods or cosmetics. [17]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Indexes for evaluating fatigue (Visual Analogue Scale for fatigue and menopause , Japanese Translation of Chalder Fatigue Scale , Japanese Translation of Profile of Mood States). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Safety [1]Blood pressure, pulsation. [2]Weight, body fat percentage, BMI. [3]Doctor's questions. [4]Subject's diary. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed