UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053429 |
|---|---|
| Receipt number | R000060964 |
| Scientific Title | Effects of test food intake on immune indicators and subjective symptoms related to physical condition changes in healthy individuals. -A randomized, placebo-controlled, double-blind, parallel-group comparison study - |
| Date of disclosure of the study information | 2024/02/02 |
| Last modified on | 2024/01/24 17:09:15 |
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Basic information
Public title
Effects of test food intake on immune indicators and subjective symptoms related to physical condition changes in healthy individuals.
-A randomized, placebo-controlled, double-blind, parallel-group comparison study -
Acronym
Effects of test food intake on immune indicators and subjective symptoms related to physical condition changes in healthy individuals.
Scientific Title
Effects of test food intake on immune indicators and subjective symptoms related to physical condition changes in healthy individuals.
-A randomized, placebo-controlled, double-blind, parallel-group comparison study -
Scientific Title:Acronym
Effects of test food intake on immune indicators and subjective symptoms related to physical condition changes in healthy individuals.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain new physiological function data of test food and clarify its immune activation effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major immune markers
Key secondary outcomes
questionnaire (Physical condition, QOL)
Other immune markers
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
Consume test food once a day for 8 weeks.
Interventions/Control_2
Consume placebo food once a day for 8 weeks.
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) Healthy males and females aged 20 to 64 years-old.
2) Subjects who have reported being susceptible to colds and influenza and have had upper respiratory infections within the past two years.
3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
Subjects(who)
1. have serious illnesses such as diabetes, kidney and liver diseases, heart diseases, thyroid diseases, adrenal diseases, other metabolic diseases, those who are undergoing treatment, and those with a medical history.
2. have a chronic disease and regularly use medications.
3. with hay fever, atopic dermatitis, bronchial asthma, and chronic bronchitis.
4. contract or have a surgical history of digestive disease affecting digestion and absorption.
5. have been diagnosed as dry mouth.
6. have dental or oral problems accompanied by bleeding (such as canker sores).
7. have received dental treatment or dental checkups within 24 hours prior to the screening test date, or willing to receive dental treatment or dental checkups within 24 hours prior to each examination.
8)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting immune functions
9. are unable to stop taking supplements and health foods (including functional foods) that may affect their immunity.
10. have an excessive drinking habit of more than approximately 60 grams of pure alcohol per day and who consume more than 20 grams of alcohol per day during the study period.
11. are unable to abstain from alcohol for 2 days before each examination, including the screening test.
12. have declared allergic reaction to ingredients of test foods.
13. smoke 21 or more cigarettes a day.
14. are under treatment for or have a history of drug addiction and/or alcoholism.
15. are shift worker and/or midnight-shift worker.
16. to 22. are listed in the "Other related information" column.
Target sample size
140
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 | Yoshika |
| Middle name | |
| Last name | Komori |
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
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
NIHON SHOKUHIN KAKO CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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 | 02 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects(who)
16. plan to travel abroad, including overseas travel, during the study period.
17. are pregnant or breastfeed or planning to become pregnant.
18. Subjects who have used drugs (including antiallergic drugs and antibiotics) that are considered to affect their immune function within 2 weeks prior to the screening test date.
19. were deemed unsuitable as research subjects based on blood tests conducted during the screening test.
20. have donated blood or blood components exceeding 200 mL within 4 weeks or 400 mL within 3 months, those who have participated in other studies within 1 month of obtaining consent, and those who intend to participate.
21. wish to receive influenza and COVID-19 (mRNA vaccine) vaccinations after October 2023.
22. were judged as unsuitable for the current study by the investigator for other reasons.
Management information
Registered date
| 2024 | Year | 01 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060964
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
