UMIN-CTR Clinical Trial

Public title

Effects of a Food Containing Mushroom Mycelium Powder to Reduce Temporal Discomfort by the Ingestion of Alcohol.

Acronym

Effects of a Food Containing Mushroom Mycelium Powder to Reduce Temporal Discomfort by the Ingestion of Alcohol.

Scientific Title

Effects of a Food Containing Mushroom Mycelium Powder to Reduce Temporal Discomfort by the Ingestion of Alcohol.

Scientific Title:Acronym

Effects of a Food Containing Mushroom Mycelium Powder to Reduce Temporal Discomfort by the Ingestion of Alcohol.

Region

Japan

Condition

Healthy adults (susceptible to alcohol)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study examines effects of a food containing mushroom mycelium powder to reduce temporal discomfort by the ingestion of alcohol.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

*Alcohol Metabolic Capacity
[1]Blood alcohol content (First observation, Second observation)
[2]Acetaldehyde (First observation, Second observation)
[3]Urine creatinine (First observation, Second observation)

Key secondary outcomes

*Antioxidant
[1]Diacron-Reactive Oxygen Metabolites test (First observation, Second observation)
[2]Biological Antioxidant Potential test (First observation, Second observation)
[3]Urinary 8-OHdG (First observation, Second observation)

*Discomfort
[1]Profile of Mood States (Japanese version) (First observation, Second observation)
[2]Visual Analogue Scale (First observation, Second observation)

*Safety
[1]Blood pressure, pulsation (Preliminary observation, First observation, Second observation)
[2]Weight, body fat percentage, BMI (Preliminary observation, First observation, Second observation)
[3]Body temperature (Preliminary observation, First observation, Second observation)
[4]Doctor's questions (Preliminary observation, First observation, Second observation)

*Other indexes
[1]Hematologic test (Preliminary observation, First observation, Second observation)
[2]Blood biochemical test (Preliminary observation, First observation, Second observation)
[3]Urine analysis (Preliminary observation, First observation, Second observation)
[4]Subject's diary (each day during the test period)
[5]Ethanol patch test (Preliminary observation)

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

[1]Oral intake of the test product (containing mushroom mycelium powder; 2 capsules / day, 1 time)
[2]Alcohol intake
[3]Observation
[4]Washout (1 week)
[5]Oral intake of the placebo product (not containing mushroom mycelium powder; 2 capsules / day, 1 time)
[6]Alcohol intake
[7]Observation

Interventions/Control_2

[1]Oral intake of the test product (not containing mushroom mycelium powder; 2 capsules / day, 1 time)
[2]Alcohol intake
[3]Observation
[4]Washout (1 week)
[5]Oral intake of the placebo product (containing mushroom mycelium powder; 2 capsules / day, 1 time)
[6]Alcohol intake
[7]Observation

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

60

years-old

>

Gender

Male and Female

Key inclusion criteria

[1]Japanese males and females aged 20-59 years
[2]Individuals who are healthy
[3]Individuals who can intake alcohol and cause flushing response or have a hangover by small amount ingestion (result of ethanol patch test is ND or NN)
[4]Individuals who do not have a habit of intaking alcohol
[5]Individuals whose written informed consent has been obtained
[6]Individuals who can come to the de signated venue for this study and be inspected
[7]Individuals judged appropriate for the study by the principal

Key exclusion criteria

[1]Individuals whose result of ethanol patch test is DD
[2]Individuals using medical products
[3]Individuals who is patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia
[4]Individuals who take medicine in the past 1 month to remedy disease (except of temporal taking medicine for headache, menstrual pain, or cold)
[5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease
[6]Individuals who is a patient or have a history of or endocrine disease
[7]Individuals whose BMI is over 30kg/m2
[8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[9]Individuals with serious anemia
[10]Individuals who are sensitive to test product or other foods, and medical products
[11]Individuals who are or are possibly, or are lactating
[12]Individuals whose life style will change during the test period (ex. a night shift, travel for a long time, job transfer)
[13]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements to improve liver function in the past 3 month or will ingest those foods during the test period
[14]Individuals who participated in other clinical studies in the past 3 months
[15]Individuals judged inappropriate for the study by the principal

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Mamoru Oki

Organization

Seishukai Medical Corporation Seishukai Hospital

Division name

Head

Zip code

Address

3-18-5 Matsugaya Taito-ku Tokyo 111-0036, JAPAN

TEL

03-3847-8866

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

Department of Clinical Trial

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

07

Month

02

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

06

Month

13

Day

Date of IRB

Anticipated trial start date

2016

Year

07

Month

04

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

07

Month

01

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=R000026453