Unique ID issued by UMIN | UMIN000022974 |
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Receipt number | R000026301 |
Scientific Title | Effects of a Food Containing Mushroom Mycelium Powder on Temporal or Long-Term Fatigue by Physical Labour, Quality of Sleep, and Vitality. |
Date of disclosure of the study information | 2016/07/01 |
Last modified on | 2017/02/09 09:45:01 |
Effects of a Food Containing Mushroom Mycelium Powder on Temporal or Long-Term Fatigue by Physical Labour, Quality of Sleep, and Vitality.
Effects of a Food Containing Mushroom Mycelium Powder on Temporal or Long-Term Fatigue by Physical Labour, Quality of Sleep, and Vitality.
Effects of a Food Containing Mushroom Mycelium Powder on Temporal or Long-Term Fatigue by Physical Labour, Quality of Sleep, and Vitality.
Effects of a Food Containing Mushroom Mycelium Powder on Temporal or Long-Term Fatigue by Physical Labour, Quality of Sleep, and Vitality.
Japan |
Healthy adults feeling tired by work
Adult |
Others
NO
This study examines effects of a food containing mushroom mycelium powder on temporal of long-term fatigue by physical labour, quality of sleep, and vitality.
Safety,Efficacy
[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)
[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)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
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; 12 weeks)
40 | years-old | <= |
65 | years-old | > |
Male and Female
[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
[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
64
1st name | |
Middle name | |
Last name | Mitsuhiro Sugimoto |
Otsubokai Medical Corporation Tohto Bunkyo Hospital
Head
3-5-7 Yushima Bunkyo-ku Tokyo 113-0034, JAPAN
03-3831-2181
info@tes-h.co.jp
1st name | |
Middle name | |
Last name | Toshiyasu Tamura |
TES Holdings Co., Ltd.
Department of Clinical Trial
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
03-6801-8480
info@tes-h.co.jp
RCT Japan Inc.
Golden Biotechnology Corp.
Profit organization
NO
2016 | Year | 07 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 06 | Month | 13 | Day |
2016 | Year | 07 | Month | 02 | Day |
2016 | Year | 07 | Month | 01 | Day |
2017 | Year | 02 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026301
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