UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047280 |
|---|---|
| Receipt number | R000053913 |
| Scientific Title | The effect of continuous intake of test foods on immune marker |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2023/03/27 08:17:14 |
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Basic information
Public title
The effect of continuous intake of test foods on immune marker
Acronym
The effect of continuous intake of test foods on immune marker
Scientific Title
The effect of continuous intake of test foods on immune marker
Scientific Title:Acronym
The effect of continuous intake of test foods on immune marker
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of continuous intake of test foods for 4 weeks on immune marker in male and female aged 20 to under 65 years old.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major immune marker
Key secondary outcomes
Questionnaires to assess health condition
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take 1 packet of test foods daily for 4 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Male and Female who aged 20 to under 65 at the time of informed consent.
2. Those who are susceptible to colds and influenza and are subject to suffered from upper respiratory tract infection within the last two years
3. Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1. Patients who have a medical history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
2. Those who have chronic diseases and use medicines constantly
3. Those with atopic dermatitis, bronchial asthma, or chronic bronchitis
4. Those who have hay fever and allergic rhinitis
5. Those who have digestive organ disease, surgical history affecting digestion and absorption of foods, or a disorder such as stenosis in the digestive tract.
6. Those who cannot stop eating foods which may activate immune functions
7. Those who have excessive smoking habits (21 or more cigarettes / day)
8. Those who have been vaccinated against influenza vaccine after October 2020, or who are planning to be vaccinated during the test period
9. Those with a food allergy
10. Those who consume alcohol excessively (alcohol equivalent 60g or more / day)
11. Those who cannot stop drinking for 2 days until the screening and each checkup
12. Those who are under treatment or have a history of drug/alcohol dependence
13. Those who work in shifts, such as those who work night shifts
14. Those who are planning to travel abroad during the test period
15. Those who are judged as unsuitable for the study based on the results of blood tests
16. Those who are positive for HBs antibody, HBs antigen or HCV antibody
17. Those who wish to become pregnant, breastfeeding, or during the test period
18. Those who donated blood over 200 mL in the past a month or over 400mL in the past three months from the date of informed consent
19. Those who are participating in other study that using food(s), or pharmaceutical(s), and cosmetic(s) now, or who have participated or are willing to participate in other studies within a month from the date of informed consent
20. Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Sagami |
Organization
Shinagawa Season Terrace Heaith Care Clinic
Division name
Director
Zip code
108-0075
Address
1-2-70, Kounan, MInato-ku, Tokyo,The 5th of Shinagawa SeasonTerrace
TEL
03-3452-3382
shinagawa@sempos.or.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7, Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Funabashiya 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,Gumma
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
| 2022 | Year | 12 | Month | 01 | 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
20
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 | 02 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 29 | 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 | 03 | Month | 25 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053913
