UMIN-CTR Clinical Trial

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 eight-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 * The common cold symptom is defined as the onset of more than one of the following symptoms: whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, blocked nose, throat pain, cough, joint pain, and muscle pain
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 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, NK cell activity 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: Brolico Administration: Take nine tablets per day in the morning * Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2	Duration: Eight weeks Test food: Placebo Administration: Take nine tablets per day in the morning * Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember 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. Japanese 2. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who catch colds easily 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects who have low scoring of immunological vigor at screening
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 use or take ""Foods for Specified Health Uses,"" ""Foods with Functional Claims,"" or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines, the test food related products, or pollen 7. Subjects who are pregnant, breast-feeding, and planning to become pregnant 8. 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 9. Subjects who are smokers 10. Subjects who have a past or current medical history of respiratory disease 11. Subjects who have an autoimmune disease 12. Subjects who have a history of salivary glands treatment 13. Subjects who are taking immunosuppressants such as steroids 14. Subjects who have received vaccination for infectious diseases such as influenza within a year 15. Subjects who have an exercise habit with 4.0 METs or more (such as vigorous running) 16. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	30

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
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	Imagine Global Care Corporation
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	2021 Year 01 Month 26 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	32
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	2021 Year 01 Month 13 Day
Date of IRB	2021 Year 01 Month 13 Day
Anticipated trial start date	2021 Year 01 Month 27 Day
Last follow-up date	2021 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 26 Day
Last modified on	2022 Year 02 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049247