UMIN-CTR Clinical Trial

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

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

RCT Japan Inc.

Institute

Department

Personal name

Organization

Golden Biotechnology 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

Date of disclosure of the study information

2016

Year

09

Month

07

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

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 related information

Registered date

2016

Year

09

Month

06

Day

Last modified on

2017

Year

02

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027250