Healthy adults feeling tired by work
Conditions
Interventions
Oral ingestion of the test products containing 150mg mushroom mycelium powder (2 grains x 1 times per a day
12 weeks)
Oral ingestion of the control products not containing mushroom emycelium powder (2 grains x 1 times per a day
Sponsors
RCT Japan Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese males and females aged 40-64 years [2]Individuals who are healthy and are not received treatment of disease [3]Individuals who feel tired by a physical labor [4]Individuals who serve a five-day work week (from Monday to Friday) and whose working hours are over 40 hours per a week [5]Individuals whose written informed consent has been obtained [6]Individuals who can come to the designated venue for this study and be inspected [7]Individuals judged appropriate for the study by the principal
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products [2]Individuals who have a history of psychiatric disease, sleep disorder, high blood pressure, diabetes, and hyperlipidemia [3]Individuals who take medicine in the past 1 month to remedy disease [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease [5]Individuals who is a patient or have a history of or endocrine disease [6]Individuals whose BMI is over 30kg/m2 [7]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [8]Individuals with serious anemia [9]Individuals who are sensitive to test product or other foods, and medical products [10]Individuals who are or are possibly, or are lactating [11]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [12]Individuals whose life style will change during the test period (ex. a night shift, travel for a long time, job transfer) [13]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 month or will ingest those foods during the test period [14]Individuals who participated in other clinical studies in the past 3 months [15]Individuals judged inappropriate for the study by the principal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Fatigue and vitality] (1)CFS (Chalder's Fatigue Scale) (Week 0, 1, 4, 8, 12) (2)Japanese Edition of Profile of Mood States (Week 0, 1, 4, 8, 12) [Sleep] (1)Pittsburgh Sleep Quality Index, Japanese Version (Week 0, 4, 8, 12) (2)Obstructive Sleep Apnea Questionnaire (Week 0, 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| [Antioxidant] (1)Diacron-Reactive Oxygen Metabolites test (Week 0, 1, 4, 8, 12) (2)Biological Antioxidant Potential test (Week 0, 1, 4, 8, 12) (3)Blood thiobarbituric acid reactive substances (Week 0, 1, 4, 8, 12) (4)Urinary isoprostane (Week 0, 4, 8, 12) (5)Urinary 8-OHdG (Week 0, 4, 8, 12) [Safety] (1)Blood pressure, pulsation (Week 0, 1, 4, 8, 12) (2)Weight, body fat percentage, BMI (Week 0, 1, 4, 8, 12) (3)Hematologic test (Week 0, 4, 8, 12) (4)Blood biochemical test (Week 0, 4, 8, 12) (5)Urine analysis (Week 0, 4, 8, 12) (6)Doctor's questions (Week 0, 1, 4, 8, 12) [Other] (1)Subject's diary (each day during the test period) | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd. Department of Clinical Trial
Outcome results
None listed