UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046154 |
|---|---|
| Receipt number | R000052679 |
| Scientific Title | A study on the effects of 8-week continuous intake of LPS-containing foods on immune function in a parallel-group randomized, double-blind trial in healthy adults |
| Date of disclosure of the study information | 2021/11/25 |
| Last modified on | 2023/01/06 13:07:39 |
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Basic information
Public title
A study on the effects of LPS-containing foods on immune function
Acronym
A study on the effects of LPS-containing foods on immune function
Scientific Title
A study on the effects of 8-week continuous intake of LPS-containing foods on immune function in a parallel-group randomized, double-blind trial in healthy adults
Scientific Title:Acronym
A study on the effects of 8-week continuous intake of LPS-containing foods on immune function in a double-blind trial
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of continuous intake of LPS-containing food for 8 weeks on immune function in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wisconsin upper respiratory symptom survey-21 (WURSS-21)
Key secondary outcomes
1)Phagocytic activity of peripheral blood cell, mCSF1 gene expression of peripheral blood leukocytes
2)Amount of IgA in saliva
3)Number of immune cells
4)Hematology examination
5)Biochemical test
6)Subjective symptoms questionnaire
7)Height, Weight, BMI
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the test food for 8 weeks
Interventions/Control_2
Intake of the placebo food 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Subjects who have received at least two doses of the new coronary vaccine at the time of intake and at least four weeks have passed since the most recent vaccination date.
2)Those who have received an explanation of the study in advance, understand its contents, and agree to participate in the study.
Key exclusion criteria
1)Those who are currently taking medication or visiting a hospital for treatment of any disease.
2)Those who are currently undergoing exercise or diet therapy under the supervision of a physician.
3)Those who may develop allergies to the test food.
4)Pregnant women and lactating women.
5)Those who are using medicines (antibiotics, immunosuppressive drugs, anti-inflammatory drugs, anti-rheumatic drugs, antihistamines, antiallergic drugs, lactobacillus preparations, etc.) that the physician in charge of the study judges may affect their participation in the study.
6)Those who are unable to stop eating foods that the physician in charge of the study judges may affect their participation in the study (health foods that may affect immune function, etc.) during the study period.
7)Those who are participating or planning to participate in other clinical trials.
8)Those who have donated 400 mL or more of blood at least three months prior to the date of consent, or 200 mL or more at least one month prior to the date of consent.
9)Those who are judged by the physician in charge of the study to be unsuitable for participation in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoshimura |
Organization
Innate Immune Network
Division name
Clinical subcommittee
Zip code
7610301
Address
Kagawa prefecture 2217-16 Takamatsu Shi Hayashi cho FROM Kagawa 3rd floor biotechnology laboratory
TEL
087-813-9201
npolsinlsin@lsin.org
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Nakamoto |
Organization
Innate Immune Network
Division name
Secretariat
Zip code
7610301
Address
Kagawa prefecture 2217-16 Takamatsu Shi Hayashi cho FROM Kagawa 3rd floor biotechnology laboratory
TEL
087-813-9201
Homepage URL
npolsinlsin@lsin.org
Sponsor or person
Institute
Innate Immune Network
Institute
Department
Personal name
Funding Source
Organization
Macrophi Inc.
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
Ethics Committee, Innate Immunity Network
Address
Kagawa prefecture 2217-16 Takamatsu Shi Hayashi cho FROM Kagawa 3rd floor biotechnology laboratory
Tel
087-813-9201
npolsinlsin@lsin.org
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
| 2021 | Year | 11 | Month | 25 | 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
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | 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
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052679
