UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048135 |
|---|---|
| Receipt number | R000054841 |
| Scientific Title | Effects of consumption of the test food on the immune function in healthy Japanese subjects: an open-label trial |
| Date of disclosure of the study information | 2022/06/22 |
| Last modified on | 2023/07/05 18:19:59 |
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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
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
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
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
17
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
| 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
| 2023 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054841
