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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033706
Receipt No. R000038302
Official scientific title of the study Optimal intake dose setting test of Basidiomycetes-X
Date of disclosure of the study information 2018/08/10
Last modified on 2018/08/30

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Basic information
Official scientific title of the study Optimal intake dose setting test of Basidiomycetes-X
Title of the study (Brief title) Optimal intake dose setting test of Basidiomycetes-X
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to establish the optimal dose by ingestion for 12 weeks for food containing Basidiomycetes-X and verify the safety.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ChE(6W,12W), TG(6W,12W)
Key secondary outcomes AST,ALT,Gamma-GT,ALP,LDH,T-cho,LDL-cho,HDL-cho(6W,12W)

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 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Take a test food (low dose) (12 weeks)
Interventions/Control_2 Take a test food (medium dose) (12 weeks)
Interventions/Control_3 Take the test food (high dose) (12 weeks)
Interventions/Control_4 Take the control food (12 weeks)
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 40-65 years
[2]Individuals who are healthy and are not received treatment of disease
[3]Individuals whose BMI is 23 to 30kg/m2
[4]Individuals whose written informed consent has been obtained
[5]Individuals who can come to the designated examination date and receive the examination
[6]Individuals judged appropriate for the study by the principal
Key exclusion criteria [1]Individuals using medical products
[2]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders
[3]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc.
[4]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.)
[5]Individuals with history of gastrointestinal disorders except for appendicitis
[6]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[7]Individuals who have experienced mood disorder or condition deterioration due to blood sampling in the past
[8]Individuals with serious anemia
[9]Individuals deemed sensitive to the test product or highly allergic to foods or medical drugs
[10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 40mg/day)
[11]Individuals whose number of smokers exceeds 20 on average per day
[12]Individuals whose life style will change during the test period (ex. travel for a long time)
[13]Individuals who are pregnant or are posslibly, or are lactating
[14]Individuals who participated in other clinical studies in the past three months
[15]Individual with potential conflict of interest
[16]Individuals judged inappropriate for the study by the principal
Target sample size 100

Research contact person
Name of lead principal investigator Yoshikazu Yonei
Organization Faculty of Life and Medical Sciences,Doshisha University
Division name Anti-Aging Medical Research Center
Address 1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL 0774-65-6394
Email yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person Tatsuya Honda
Organization DRC Co.,Ltd.
Division name Product Testing & Studies Division
Address Tabuchi Bldg.No.9 3F,2-10-31,Higashi-Temma,Kita-ku,Osaka
TEL 06-6882-1130
Homepage URL
Email honda@drc-web.co.jp

Sponsor
Institute Mycology Techno CORP.
Institute
Department

Funding Source
Organization Mycology Techno 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 いきいきクリニック(大阪府)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 10 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 07 Month 23 Day
Anticipated trial start date
2018 Year 08 Month 10 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
2018 Year 08 Month 10 Day
Last modified on
2018 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038302

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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