UMIN-CTR Clinical Trial

Public title

A randomized, 2 groups crossover comparison study on the effects of continuous intake of supplements containing mushroom-derived ingredients on human immune function and others

Acronym

A study on the effects of continuous intake of mushroom-derived ingredients on human immune function and others

Scientific Title

A randomized, 2 groups crossover comparison study on the effects of continuous intake of supplements containing mushroom-derived ingredients on human immune function and others

Scientific Title:Acronym

A study on the effects of continuous intake of mushroom-derived ingredients on human immune function and others

Region

Japan

Condition

Healthy subjects

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effects of continuous intake of mushroom-derived ingredients on human immune function and others

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Questionnaire for physical condition

Key secondary outcomes

1.NK cell activity
2.Levels of Cytokine in blood
3.Profile of Mood State(POMS)
4.Occupational stress
5.Levels of IgA in blood
6.Food Frequency Questionnaire
7.Physical activity questionnaire
8.Safety evaluation (General biochemical test)

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) 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

8 tablets/day of Supplements containing mushroom-derived ingredients intake for 4 weeks

Interventions/Control_2

8 tablets/day of Placebo tablet intake for 4 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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Japanese men and women aged 20 years or older at the time of registration (As a general rule, only workers).
2.Those who are aware that they tend to get sick during winter or when seasons change (Priority will be given to those who have had two or more upper respiratory tract infections within the past year.)
3.Those who do not have any disease receiving continuous treatment, medication, and lifestyle guidance.
4.Those who do not plan to take drugs (including over-the-counter drugs) for allergic diseases such as hay fever, bronchial asthma, or chronic bronchitis during the research period.
5.Those who can respond to electronic diaries and questionnaire surveys on a PC
6Those who can use Excel, Word, and online meeting tools 7.Those who are able to report daily on test food intake status and physical condition using an electronic diary.
8.Priority will be given to those who have not been vaccinated within the past month and have no plans to be vaccinated during the trial period.
9.Those who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.

Key exclusion criteria

1.Those who are receiving any types of medicines and/or Chinese medical treatment except a dose of medicine taken only once.
2.Those who had been experiencing a severe disease.
3.Those who have a drug/food allergy. (Those who may have an allergic reaction when ingesting the test food)
4.Those who have currently been taking commercially available drugs, quasi-drug products, and foods or supplements with functional claims. However, those who can discontinue taking these foods during the trial period after obtaining informed consent will be allowed to join the trial.
5.Those who drink more than 60 g alcohol/day.
6.Those who have excessive smoking habits (21 or more cigarettes/day).
7.Those who frequently have to redo of blood for medical examinations, and who have felt unwell due to blood collection in the past.
8.Those who work on the shiftwork.
9.Those who have plans of major change on their lifestyle (e.g. diet, sleep and exercise) during the study period.
10.Those who are planning to travel abroad during the study period.
11.Those who have joined other clinical trials in the past 1 month before receiving informed consent in this study, or are currently joining other clinical trials, or are planning to join other clinical trials.
12.Women who are pregnant or may become pregnant, or lactating.
13.Those who are unsuitable for this trial that judged by the principal investigator.

Target sample size

80

Name of lead principal investigator

1st name	Risa
Middle name
Last name	Araki

Organization

National Agriculture and Food Research Organization

Division name

Institute of Food Research, National Agriculture and Food Research Organization

Zip code

305-8642

Address

Kannondai 2-1-12, Tsukuba, Ibaraki, Japan

TEL

0298388083

Email

arakir778@affrc.go.jp

Name of contact person

1st name	Risa
Middle name
Last name	Araki

Organization

National Agriculture and Food Research Organization

Division name

Institute of Food Research, National Agriculture and Food Research Organization

Zip code

305-8642

Address

Kannondai 2-1-12, Tsukuba, Ibaraki, Japan

TEL

0298388083

Homepage URL

Email

arakir778@affrc.go.jp

Institute

National Agriculture and Food Research Organization

Institute

Department

Personal name

Organization

Ministry of Agriculture, Forestry and Fisheries

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

NARO Human Subjects Research Ethics Review Committee

Address

Kannondai 3-1-1, Tsukuba, Ibaraki, Japan

Tel

029-838-6932

Email

naro-human-jikken@ml.affrc.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

農研機構食品研究部門（茨城県）

Date of disclosure of the study information

2026

Year

03

Month

31

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

Open public recruiting

Date of protocol fixation

2023

Year

09

Month

21

Day

Date of IRB

2023

Year

09

Month

21

Day

Anticipated trial start date

2023

Year

10

Month

27

Day

Last follow-up date

2024

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

01

Month

11

Day

Last modified on

2024

Year

01

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060868