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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023945
Receipt No. R000027250
Scientific Title Safety of Overconsumption (Five Dose) of a Food Containing of Mushroom Mycelium
Date of disclosure of the study information 2016/09/07
Last modified on 2017/02/09

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Basic information
Public title Safety of Overconsumption (Five Dose) of a Food Containing of Mushroom Mycelium
Acronym Safety of Overconsumption (Five Dose) of a Food Containing of Mushroom Mycelium
Scientific Title Safety of Overconsumption (Five Dose) of a Food Containing of Mushroom Mycelium
Scientific Title:Acronym 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
1st name
Middle name
Last name Takahiro Ono
Organization Medical Corporation Wakei-kai Medics Hongo Clinic
Division name Director
Zip code
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
1st name
Middle name
Last name Toshiyasu Tamura
Organization TES Holdings Co., Ltd.
Division name Division of Clinical Trial, Department of Development for Clinical Trials
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 08 Month 23 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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