UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food on the immune function in healthy Japanese subjects: an open-label trial
Acronym	Effects of consumption of the test food on the immune function in healthy Japanese subjects: an open-label trial
Scientific Title	Effects of consumption of the test food on the immune function in healthy Japanese subjects: an open-label trial
Scientific Title:Acronym	Effects of consumption of the test food on the immune function in healthy Japanese subjects
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 consumption of the test food on the immune function as well as the secondary effects on sleep quality and subjective fatigue/stress in healthy Japanese subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Scoring of immunological vigor
Key secondary outcomes	1. T lymphocyte age, the rate of CD3+T cells, the number of CD3+T cells, the score of CD3+T cells, the rate of CD4+T cells, the number of CD4+T cells, the rate of CD8+T cells, the number of CD8+T cells, the rate of naive T cells (CD4+), the number of naive T cells (CD4+), the score of naive T cells (CD4+), the rate of memory T cells (CD4+), the number of memory T cells (CD4+), the score of memory T cells (CD4+), CD8+CD28+T cells, the rate of B (CD20+) cells, the number of B cells (CD20+), the score of B cells (CD20+), the rate of NK cells (CD56+CD16-), the rate of NK cells (CD56+CD16+), the rate of NK cells (CD56-CD16+), the number of NK cells, the score of NK cells, the ratio of CD4+/CD8+T cells, the score of ratio of CD4+/CD8+T cells, the ratio of naive T cells to memory T cells, the score of ratio of naive T cells to memory T cells, and immunological grade 2. "Sleepiness on rising", "Initiation and maintenance of sleep", "frequent dreaming", "refreshing", "sleep length", and each item in the OSA sleep inventory MA version 3. The total score, "Sleep quality"(C1), "Sleep latency"(C2), "Sleep duration"(C3), "Habitual sleep efficiency"(C4), "Sleep disturbance"(C5), "Use of sleeping medication"(C6), "Daytime dysfunction"(C7), and each items in Pittsburgh Sleep Quality Index 4. Sleep score, sleep onset, sleep offset, midpoint of sleep, time in bed after sleep offset, sleep onset latency, StageR latency, NotScored total time, N1 total time, N2 total time, N3 total time, REM (rapid eye moving) total time, total sleep time (TST), wake time after sleep onset (WASO), sleep efficiency[%total recording time (TRT)], percentage of N1[%TST], percentage of N2[%TST], percentage of N3[%TST], and percentage of REM[%TST] in sleep test 5. LF (low frequency), HF (how frequency), LF/HF ratio, average heart rate, maximum heart rate, minimum heart rate, TP (total power), ccvTP (coefficient of component variance TP), deviation value of autonomic function, and autonomic functional age

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Duration: Test food: Food containing fermented Panax ginseng, fermented Korean red ginseng extract, and royal jelly Administration: Take two packets with water without chewing at any time during the day * 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
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Japanese 2. Men or women 3. Subjects aged 40 or more 4. Healthy subjects 5. Subjects who easily catch colds and are concerned about sleep quality 6. Subjects whose scoring of immunological vigor are relatively low at screening (before consumption; Scr)
Key exclusion criteria	Subjects (who/whose) 1.undergoing medical treatment or having a medical history of malignant tumor, heart failure, and myocardial infarction 2.have a pacemaker or an ICD 3.undergoing treatment for chronic diseases such as arrhythmia, hepatopathy, nephropathy, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, or hypertension 4.take "Foods for Specified Health Uses," or "Foods with Functional Claims" on daily 5.usually taking medicines (including herbal medicines) or supplements 6.are allergic to medicines or the test food related products 7.are pregnant or lactation / become pregnant 8.have COVID-19 9.have been enrolled in other clinical trials within the last 3 months before the agreement to participate in this trial or plan to participate in another trial during this trial 10.judged as ineligible to participate in the study by the physician 11.working hours are irregular 12.have irregular ifestyles (such as diet, and exercise) 13.sleep habits are irregular 14.usually sleeping less than 6 hours / will sleep less than 6 hours during the test period on daily 15.live with their infants less than one year old 16.sleep with their children (1 to 6 years old) 17. live with requiring long-term care persons 18.sleep with more than one person 19. have nocturia three times or more 20.drink to excess (average of more than about 20 g/day as absolute alcohol intake) 21.take food/beverage containing functional ingredients that may influence immune function, sleep quality, or subjective fatigue/stress 22.have autoimmune disease 23.taking immunosuppressants 24.have perennial allergic rhinitis 25.undergoing treatment for sleep disorder such as insomnia or sleep apnea syndrome 26.smoke 27.have medical history of dermatitis, hypotension, atopy, bronchial asthma, cardiopathy, organ transplantation, psychiatric disorder, HIV/AIDS, short bowel syndrome, arteriosclerosis, histoplasmosis, hypercalcemia, lymphoma, sarcoidosis, or tuberculosis
Target sample size	15

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 Bldg., 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	NAGASE BeautyCare 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	2022 Year 06 Month 22 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
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	Open public recruiting
Date of protocol fixation	2022 Year 06 Month 15 Day
Date of IRB	2022 Year 06 Month 15 Day
Anticipated trial start date	2022 Year 06 Month 23 Day
Last follow-up date	2022 Year 11 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 06 Month 22 Day
Last modified on	2022 Year 06 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054841

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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