UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of a Food Containing Mushroom Mycelium Powder on Temporal or Long-Term Fatigue by Physical Labour, Quality of Sleep, and Vitality.
Title of the study (Brief title)	Effects of a Food Containing Mushroom Mycelium Powder on Temporal or Long-Term Fatigue by Physical Labour, Quality of Sleep, and Vitality.
Region	Japan

Condition
Condition	Healthy adults feeling tired by work
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[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)
Key secondary outcomes	[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)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test products containing 150mg mushroom mycelium powder (2 grains x 1 times per a day; 12 weeks)
Interventions/Control_2	Oral ingestion of the control products not containing mushroom emycelium powder (2 grains x 1 times per a day; 12 weeks)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key 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
Key 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
Target sample size	64

Research contact person
Name of lead principal investigator	Mitsuhiro Sugimoto
Organization	Otsubokai Medical Corporation Tohto Bunkyo Hospital
Division name	Head
Address	3-5-7 Yushima Bunkyo-ku Tokyo 113-0034, JAPAN
TEL	03-3831-2181
Email	info@tes-h.co.jp

Public contact
Name of contact person	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd.
Division name	Department of Clinical Trial
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	03-6801-8480
Homepage URL
Email	info@tes-h.co.jp

Sponsor
Institute	RCT Japan Inc.
Institute
Department

Funding Source
Organization	Golden Biotechnology Corp.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 13 Day
Anticipated trial start date	2016 Year 07 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 01 Day
Last modified on	2017 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026301