UMIN-CTR Clinical Trial

Public title

Effects of a Food Containing Mushroom Mycelium Powder on Temporal or Long-Term Fatigue by Physical Labour, Quality of Sleep, and Vitality.

Acronym

Effects of a Food Containing Mushroom Mycelium Powder on Temporal or Long-Term Fatigue by Physical Labour, Quality of Sleep, and Vitality.

Scientific Title

Effects of a Food Containing Mushroom Mycelium Powder on Temporal or Long-Term Fatigue by Physical Labour, Quality of Sleep, and Vitality.

Scientific Title:Acronym

Effects of a Food Containing Mushroom Mycelium Powder on Temporal or Long-Term Fatigue by Physical Labour, Quality of Sleep, and Vitality.

Region

Japan

Condition

Healthy adults feeling tired by work

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study examines effects of a food containing mushroom mycelium powder on temporal of long-term fatigue by physical labour, quality of sleep, and vitality.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[Fatigue and vitality]
(1)CFS (Chalder's Fatigue Scale) (Week 0, 1, 4, 8, 12)
(2)Japanese Edition of Profile of Mood States (Week 0, 1, 4, 8, 12)
[Sleep]
(1)Pittsburgh Sleep Quality Index, Japanese Version (Week 0, 4, 8, 12)
(2)Obstructive Sleep Apnea Questionnaire (Week 0, 1)

Key secondary outcomes

[Antioxidant]
(1)Diacron-Reactive Oxygen Metabolites test (Week 0, 1, 4, 8, 12)
(2)Biological Antioxidant Potential test (Week 0, 1, 4, 8, 12)
(3)Blood thiobarbituric acid reactive substances (Week 0, 1, 4, 8, 12)
(4)Urinary isoprostane (Week 0, 4, 8, 12)
(5)Urinary 8-OHdG (Week 0, 4, 8, 12)
[Safety]
(1)Blood pressure, pulsation (Week 0, 1, 4, 8, 12)
(2)Weight, body fat percentage, BMI (Week 0, 1, 4, 8, 12)
(3)Hematologic test (Week 0, 4, 8, 12)
(4)Blood biochemical test (Week 0, 4, 8, 12)
(5)Urine analysis (Week 0, 4, 8, 12)
(6)Doctor's questions (Week 0, 1, 4, 8, 12)
[Other]
(1)Subject's diary (each day during the test period)

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

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Oral ingestion of the test products containing 150mg mushroom mycelium powder (2 grains x 1 times per a day; 12 weeks)

Interventions/Control_2

Oral ingestion of the control products not containing mushroom emycelium powder (2 grains x 1 times per a day; 12 weeks)

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

40

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

[1]Japanese males and females aged 40-64 years
[2]Individuals who are healthy and are not received treatment of disease
[3]Individuals who feel tired by a physical labor
[4]Individuals who serve a five-day work week (from Monday to Friday) and whose working hours are over 40 hours per a week
[5]Individuals whose written informed consent has been obtained
[6]Individuals who can come to the designated venue for this study and be inspected
[7]Individuals judged appropriate for the study by the principal

Key exclusion criteria

[1]Individuals using medical products
[2]Individuals who have a history of psychiatric disease, sleep disorder, high blood pressure, diabetes, and hyperlipidemia
[3]Individuals who take medicine in the past 1 month to remedy disease
[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 30kg/m2
[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 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 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 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

64

Name of lead principal investigator

1st name
Middle name
Last name	Mitsuhiro Sugimoto

Organization

Otsubokai Medical Corporation Tohto Bunkyo Hospital

Division name

Head

Zip code

Address

3-5-7 Yushima Bunkyo-ku Tokyo 113-0034, JAPAN

TEL

03-3831-2181

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

01

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

02

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=R000026301