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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046154
Receipt No. 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 2021/11/24

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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
Email 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
Email npolsinlsin@lsin.org

Sponsor
Institute Innate Immune Network
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 11 Month 15 Day
Date of IRB
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
2021 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052679

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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