UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046160
Receipt No. R000052685
Scientific Title The verifying efficacy and safety of test food consumption on immune function in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Date of disclosure of the study information 2021/11/24
Last modified on 2021/11/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of consumption of test food consumption on immune function in healthy Japanese subjects
Acronym The verifying efficacy and safety of test food consumption on immune function in healthy Japanese subjects
Scientific Title The verifying efficacy and safety of test food consumption on immune function in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym The verifying efficacy and safety of test food consumption on 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 efficacy and safety of test food consumption on immune function and inflammatory markers in healthy Japanese subjects
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. 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 measured values and amount of change from before consumption (Scr) in each of the following items at eight weeks after consumption (8w):
immunity test {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}, the amount of change of inflammatory markers {interleukin (IL)-6, IL-1 beta, tumor necrosis factor-alfa, high sensitivity C-reactive protein, the number of leukocyte, leukocyte image (the ratio and number of neutrophil, lymphocyte, monocyte, eosinophil, and basophil)} and neutrophil/lymphocyte ratio

3. The measured values and amount of change from Scr in each of the following items at 8w and 12 weeks after consumption (12w): Circulating markers of liver function {asparate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyltranspeptidase (gamma-GT)}, body weight, body mass index, body fat percentage, and muscle mass

* 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

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 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Duration: 12 weeks
Test food: A
Administration: Take two capsules of the test food with water before 10 to 15 minutes in breakfast and dinner

*If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2 Duration: 12 weeks
Test food: B
Administration: Take two capsules of the test food with water before 10 to 15 minutes in breakfast and dinner

*If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_3 Duration: 12 weeks
Test food: Placebo
Administration: Take two capsules of the test food with water before 10 to 15 minutes in breakfast and dinner

*If you forget to take the test food, take it as soon as you remember within the day.
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 are judged as eligible to participate in the study by the physician

6. Subjects whose scoring of immunological vigor is relatively low
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. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, gastroesophageal reflux disease, hormone sensitive diseases, iron deficiency, or any other chronic diseases

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

5. Subjects currently taking medicines (include herbal medicines) and supplements

6. Subjects who are allergic to medications and/or the test-food-related products

7. Subjects who suffer from COVID-19

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

9 .Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

10. Subjects who are smokers

11. Subjects who have autoimmune disease

12. Subjects who are taking immunosuppressants such as steroids

13. Subjects who have received vaccination for influenza within the last three months

14. Subjects who have surgery within the last two weeks

15. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 90

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 Theravalues,Inc
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 11 Month 24 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
2021 Year 11 Month 17 Day
Date of IRB
2021 Year 11 Month 17 Day
Anticipated trial start date
2021 Year 11 Month 24 Day
Last follow-up date
2022 Year 05 Month 27 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 11 Month 24 Day
Last modified on
2021 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052685

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.