UMIN-CTR Clinical Trial

Public title

Optimal intake dose setting test of Basidiomycetes-X

Acronym

Optimal intake dose setting test of Basidiomycetes-X

Scientific Title

Optimal intake dose setting test of Basidiomycetes-X

Scientific Title:Acronym

Optimal intake dose setting test of Basidiomycetes-X

Region

Japan

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yoshikazu Yonei

Organization

Faculty of Life and Medical Sciences,Doshisha University

Division name

Anti-Aging Medical Research Center

Zip code

Address

1-3 Tatara Miyakodani,Kyotanabe City,Kyoto

TEL

0774-65-6394

Email

yyonei@mail.doshisha.ac.jp

Name of contact person

1st name
Middle name
Last name	Tatsuya Honda

Organization

DRC Co.,Ltd.

Division name

Product Testing & Studies Division

Zip code

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

Institute

Mycology Techno CORP.

Institute

Department

Personal name

Organization

Mycology Techno CORP.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

いきいきクリニック（大阪府）

Date of disclosure of the study information

2018

Year

08

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

07

Month

23

Day

Date of IRB

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

Other related information

Registered date

2018

Year

08

Month

10

Day

Last modified on

2018

Year

12

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038302