UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048938 |
|---|---|
| Receipt number | R000055758 |
| Scientific Title | A study to confirm the effect of research food intake on immune function - Randomized, double-blind, parallel-group comparison method -. |
| Date of disclosure of the study information | 2024/01/30 |
| Last modified on | 2024/02/27 11:33:40 |
* 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
A study to confirm the effect of research food intake on improving immune function - Randomized, double-blind, parallel-group comparison method
Acronym
A study to confirm the effect of research food intake on improving immune function
Scientific Title
A study to confirm the effect of research food intake on immune function - Randomized, double-blind, parallel-group comparison method -.
Scientific Title:Acronym
A study to confirm the effect of research food intake on improving immune function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of the intake of the research food on immune function with control foods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NK cell activity
Key secondary outcomes
pDC activity, salivary sIgA (concentration, rate of secretion, amount secreted), concentration of IFN-alfa in blood, cold-like symptoms questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
4-week intake of research food (high dose)
Interventions/Control_2
4-week intake of research food (low dose)
Interventions/Control_3
4-week intake of control food
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. Males and females from 20 to 65 years old at the time of the informed.
2. Subjects who often suffer from fever or illness.
3. Subjects who have been fully informed of the purpose and content of the research, have the capacity to consent, and have voluntarily volunteered to participate based on a good understanding of the purpose and content of the research, and have agreed to participate in the research in writing.
Key exclusion criteria
Subjects - -
1. scheduled to be vaccinated for 3 weeks prior to each examination.
2. suffering from diabetes, renal or hepatic disease or other serious diseases, or metabolic diseases, autoimmune diseases, undergoing treatment, or with a history of such diseases.
3. with chronic illnesses who take pharmaceuticals on a daily basis.
4. who regularly use medicines that may affect immunity, foods for specified health uses, etc, and who are unable to stop taking them during the study period.
5. who are unable to stop taking Lactobacillus and Bifidobacteria-rich foods during the study period.
6. who have taken antibiotics for 1 month prior to the screening test.
7. who constantly consumes alcohol in excess of the appropriate amount.
8. who are unable to abstain from alcohol for 2 days prior to each test.
9. with declared food allergies.
10. with a history or current history of hay fever.
11. with atopic dermatitis, allergic rhinitis, bronchial asthma, or chronic bronchitis.
12. who work day and night shifts.
13. who work full-time telecommuters.
14. who have dental or oral problems that involve bleeding, or plan to undergo dental or oral treatment.
15. who have a habit of jogging or other strenuous exercise.
16. who smoke.
17. with gastrointestinal diseases and absorption and a history of gastrointestinal surgery (except appendicitis).
18. who a pregnant, intending to become pregnant during the study period, or breastfeeding.
19. with a history or current history of drug or alcohol dependence.
20. who are currently participating in research involving the ingestion of other foods or the use of pharmaceuticals, or who intend to participate in such research.
21. who have donated more than 200 mL of blood or component blood within 1 month or 400 mL within 3 months prior to the date consent was obtained.
22. who deemed inappropriate as research subjects by the principal investigator--.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Yoshikawa |
| Middle name | |
| Last name | Eiji |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.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
| 2024 | Year | 01 | Month | 30 | 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
75
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 | 08 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | 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 | 09 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055758
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
