UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052736 |
|---|---|
| Receipt number | R000060170 |
| Scientific Title | A Confirmatory Study of the Immunomodulatory Function of Test Supplements in Healthy Adults - A Randomized, Double-Blind, Placebo-Controlled Comparative Trial |
| Date of disclosure of the study information | 2023/11/12 |
| Last modified on | 2023/11/30 09:50:04 |
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Basic information
Public title
A Confirmatory Study of the Immunomodulatory Function of Test Supplements in Healthy Adults - A Randomized, Double-Blind, Placebo-Controlled Comparative Trial
Acronym
A Confirmatory Study of the Immunomodulatory Function of Test Supplements in Healthy Adults
Scientific Title
A Confirmatory Study of the Immunomodulatory Function of Test Supplements in Healthy Adults - A Randomized, Double-Blind, Placebo-Controlled Comparative Trial
Scientific Title:Acronym
A Confirmatory Study of the Immunomodulatory Function of Test Supplements in Healthy Adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the immunostimulatory effect of test supplements in men and women aged 20 to 64 years with 12-week continuous intake.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective questionnaire
Key secondary outcomes
Protein expression of cell surface antigens on plasmacytoid dendritic cells (HLA-DR, CD40, CD80, CD86 on CD123+/BDCA4+ cells)
NK cell cytotoxicity
IFN-alpha and IL-12 level in blood
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take six tablets of the placebo supplement with water or warm water after breakfast every day.
Interventions/Control_2
Take six tablets of the active supplement with water or warm water after breakfast every 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Over 20 years old and less than 65 years old.
2. Male and female.
3. BMI is over 18.5 kg/m^2 and less than 30 kg/m^2.
4. Those who have been upper respiratory infection diseases or common-cold-like symptoms over one time every year.
5. Those who work outside the home for at least 3 days of the week.
6. Those who can use smartphones or PC to record a digital diary.
7. Received a sufficient explanation for the study objective, and voluntarily joined the study with the agreement to informed consent.
Key exclusion criteria
1.Currently receiving any medical treatment with drugs or Chinese herbs. Medications used as needed are acceptable.
2.Currently receiving any dietary treatment or exercise treatment under medical doctors.
3.Have malignancy or serious illnesses, or a history of serious illnesses in respiratory, digestive, endocrine, or metabolic organs.
4.Have been received resection of digestive organs, excluding cecum resection.
5.Have been used medical drugs which have immune modulatory effects, such as anti-allergy drugs and antibiotics, within one month before the screening visit.
6.Have been taking foods or dietary supplements with functional health claims that affect the outcome of the study. Who can discontinue intake during the study is acceptable.
7.Voluntarily consume yogurt or beverages containing lactic acid bacteria and bifidobacterial, over three times per week. Who can discontinue intake during the study is acceptable.
8.Have allergic rhinitis.
9.Have a history or current condition of asthma or atopic dermatitis.
10.Have allergies to drugs or foods.
11.Workers on night shifts or with irregular work schedules.
12.Have been vaccinated against influenza viruses or SARS-CoV-2 or infected with these viruses within 12 weeks before the screening visit, or are planning to be vaccinated during the study.
13.Heavy Smoker, over 21 cigarettes/day.
14.Alcohol drinkers, over 40 g/day of pure alcohol.
15.Are planning to make significant changes in lifestyle, such as eating habits, sleep duration, or exercise habits.
16.Are planning to travel abroad during the study period.
17.Currently pregnant or breastfeeding, or planning to become pregnant during the study.
18.Those who have participated in other clinical trials within one month before enrolling in the study, those who are currently participating in other clinical trials, and those who plan to participate in other clinical trials after enrolling in the study.
19.Who are unsuitable for the study, as determined by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Nozaki |
Organization
BHN Co., Ltd.
Division name
Research and Development Dept.
Zip code
101-0054
Address
1-16, Kandanishiki, Chiyoda, Tokyo, 101-0054, Japan
TEL
03-5281-5661
t-nozaki@bhn.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
BHN Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.co.jp
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 08 | Day |
Last modified on
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060170
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| Registered date | File name |
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