UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042195
Receipt number R000048166
Scientific Title Effects of consumption of the test food on the immune function: A randomized, double-blind, placebo-controlled, parallel-group comparison trial
Date of disclosure of the study information 2020/10/21
Last modified on 2022/10/28 14:17:51

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Basic information

Public title

Effects of consumption of the test food on the immune function

Acronym

Effects of consumption of the test food on the immune function

Scientific Title

Effects of consumption of the test food on the immune function: A randomized, double-blind, placebo-controlled, parallel-group comparison trial

Scientific Title:Acronym

Effects of consumption of the test food on the immune function

Region

Japan


Condition

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effects of 8-week consumption of the test food on the immune function

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The cumulative number of days with common cold symptoms during the intervention period per subject

Key secondary outcomes

1. The maximum duration of the days with common cold symptoms during the intervention period per subject

2. The cumulative number of days with common cold symptoms during the intervention period per group

3. The percentage of subjects who have infected with the influenza virus during the intervention period

4. The measured values and changes from screening and advance examination of the following items at four and eight weeks after consumption:
physical component summary (PCS), mental component summary (MCS), physical functioning, role physical, bodily pain, general health, social functioning, role emotional, mental health, scoring of immunological vigor, immunological grade, T lymphocyte age (upper limit), the score of T cells, the score of CD8+CD28+T cells, the score of ratio of CD4+T cells to CD8+T cells, the score of naive T cells, the score of ratio of naive T cells to memory T cells, the score of B cells, the score of NK cells, the number of T cells, the ratio of CD4+T cells to CD8+T cells, the number of naive T cells, the ratio of naive T cells to memory T cells, the number of B cells, the number of NK cells, the number of CD8+CD28+T cells, and salivary IgA


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: Eight weeks
Test food: Sulforaphane glucosinolate powder
Administration: Take one pack per day at any time during the day

* Daily dose should be taken within the day.

Interventions/Control_2

Duration: Eight weeks
Test food: Placebo powder
Administration: Take one pack per day at any time during the day

* Daily dose should be taken within the day.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Healthy Japanese adult subjects

2. Subjects who catch colds easily

3. Subjects who are judged as eligible to participate in the study by the physician

4. Subjects who have relatively low scoring of general health in SF-8 (SF8 Health Survey) at screening (before consumption)

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who are pollen allergy

5. Subjects who have a past or current medical history of respiratory disease

6. Subjects who have an autoimmune disease

7. Subjects who are taking immunosuppressants such as steroids

8. Subjects who have received vaccination for infectious diseases such as influenza

9. Subjects who have a vigorous exercise habit

10. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily

11. Subjects who take broccoli sprouts in daily

12. Subjects who are currently taking medications (including herbal medicines) and supplements

13. Subjects who are allergic to medicines and/or the test food related products

14. Subjects who are pregnant, breast-feeding, and planning to become pregnant

15. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial

16. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Tsuyoshi
Middle name
Last name Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

TEL

03-5793-3623

Email

t-takara@takara-clinic.com


Public contact

Name of contact person

1st name Naoko
Middle name
Last name Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL


Email

nao@orthomedico.jp


Sponsor or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



Funding Source

Organization

MURAKAMI FARM CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

IRB@takara-clinic.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)


Other administrative information

Date of disclosure of the study information

2020 Year 10 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

66

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



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 10 Month 16 Day

Date of IRB

2020 Year 10 Month 16 Day

Anticipated trial start date

2020 Year 10 Month 22 Day

Last follow-up date

2021 Year 04 Month 02 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 10 Month 21 Day

Last modified on

2022 Year 10 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048166


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name