UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety of Overconsumption (Five Dose) of a Food Containing of Mushroom Mycelium
Title of the study (Brief title)	Safety of Overconsumption (Five Dose) of a Food Containing of Mushroom Mycelium
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines safety of overconsumption (five dose) of a food containing of mushroom mycelium.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Existence and its contents of side effects(Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods)
Key secondary outcomes	*Secondary outcomes [1]Adverse events (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [2]Blood pressure, pulsation (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [3]Weight, body fat percentage, BMI (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [4]Body temperature (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [5]Hematologic test (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [6]Blood biochemical test (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [7]Urine analysis (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [8]Doctor's questions (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) *Other index [1]Subject's diary (each day during the test period)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Oral intake of the test product (containing mushroom mycelium powder; 10 capsules / day for 4 weeks)
Interventions/Control_2
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	20 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Japanese males and females aged 20-69 years [2]Individuals who are sensitive to the cold [3]Individuals whose written informed consent has been obtained [4]Individuals who can come to the designated venue for this study and be inspected [5]Individuals judged appropriate for the study by the principal
Key exclusion criteria	[1]Individuals using medical products [2]Individuals who is patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia [3]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis) [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 30 [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 a 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 with possible changes of life style, such as conducting a long-term travel, during the test period [13]Individuals who participated in other clinical studies in the past 3 months [14]Individuals judged inappropriate for the study by the principal
Target sample size	20

Research contact person
Name of lead principal investigator	Takahiro Ono
Organization	Medical Corporation Wakei-kai Medics Hongo Clinic
Division name	Director
Address	2-2-6 Mukogaoka Bunkyo-ku Hongo Tokyo 113-0023, JAPAN
TEL	03-6801-9761
Email	info@tes-h.co.jp

Public contact
Name of contact person	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd.
Division name	Division of Clinical Trial, Department of Development for Clinical Trials
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 09 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 23 Day
Anticipated trial start date	2016 Year 09 Month 14 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 09 Month 06 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=R000027250