Effects of a Food Containing Mushroom Mycelium Powder on Temporal or Long-Term Fatigue by Physical Labour, Quality of Sleep, and Vitality.
- Conditions
- Healthy adults feeling tired by work
- Registration Number
- JPRN-UMIN000022974
- Lead Sponsor
- RCT Japan Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 64
Not provided
[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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [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 Outcome Measures
Name Time Method [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)