UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058011 |
|---|---|
| Receipt number | R000066313 |
| Scientific Title | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study to Evaluate the Efficacy of Oral Lipopolysaccharide Derived from Pantoea agglomerans in Preventing Cognitive Decline |
| Date of disclosure of the study information | 2025/06/02 |
| Last modified on | 2025/05/30 15:56:00 |
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Basic information
Public title
Evaluation of the efficacy of LPS derived from Pantoea agglomerans in preventing cognitive decline:RCT
Acronym
Evaluation of the efficacy of LPS derived from Pantoea agglomerans in preventing cognitive decline:RCT
Scientific Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study to Evaluate the Efficacy of Oral Lipopolysaccharide Derived from Pantoea agglomerans in Preventing Cognitive Decline
Scientific Title:Acronym
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study to Evaluate the Efficacy of Oral Lipopolysaccharide Derived from Pantoea agglomerans in Preventing Cognitive Decline
Region
| Japan |
Condition
Condition
Cognitively normal status at the preclinical stage of mild cognitive impairment
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy of consumption of the LPS derived from Pantoea agglomerans in preventing cognitive decline in healthy individuals with cognitive declin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cognitive function measurement scores using the Cognitrax test 12 weeks after intake
(Raw test scores and standardized scores for each cognitive domain, raw test scores and standardized scores for each cognitive domain comprising overall memory, and changes and rates of change from screening tests).
Key secondary outcomes
1. Total score on the Mini-Mental State Examination (MMSE) 12 weeks after consumption of the test food (actual values, change from pre-consumption test, and rate of change)
2. Hippocampal volume measured by MRI (Brain Suite) (actual values and comparison values for same sex and age group, change from pre-consumption test, and rate of change)
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
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food: Tablets containing LPS from Pantoea agglomerans
Duration of intake: 12 weeks
Dosage and administration: 3 tablets daily intake
Interventions/Control_2
Control food: Pantoea agglomerans-derived LPS-free tablets
Intake period: 12 weeks
Dosage and administration: 3 tablets daily intake
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, and have freely volunteered to participate in the trial with their consent obtained in writing.
2.Men and women aged 60 to 79 years.
3.Individuals who scored between 89 and 102 points on the Cognitrax test administered during screening (total score of language memory and visual memory: 60 points each, total 120 points).
4.Individuals who are able to consume the trial food provided daily in the specified amounts.
Key exclusion criteria
1. Individuals who have been diagnosed with dementia by a physician
2. Individuals currently taking or who have previously taken medications for dementia
3. Individuals who cannot cease consumption of foods containing ingredients recognized to improve cognitive function
4. Individuals with severe symptoms of diabetes, liver disease, kidney disease, cerebrovascular disease, heart disease, malignant neoplasms, or other conditions
5. Individuals deemed unsuitable as participants based on responses to the participant background survey
6. Individuals with a history of alcohol dependence or current alcohol dependence
7. Individuals with injuries or illnesses that impair the ability to operate computers, smartphones, tablets, or other devices, or to perform cognitive function tests
8. Individuals who have reported food allergies to any components of the test food
9. Individuals with extremely irregular eating habits or lifestyle rhythms
10. Pregnant women, women who intend to become pregnant during the trial period, or women who are currently breastfeeding
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Maya |
| Middle name | |
| Last name | Uenobe |
Organization
Nonprofit Organization Innate Immune Network
Division name
Clinical subcommittee
Zip code
761-0301
Address
Bio Research Laboratory, 3rd Floor, FROM Kagawa, 2217-16 Hayashi-cho, Takamatsu City, Kagawa
TEL
087-813-9201
uenobe.maya@u-nagano.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Nakamoto |
Organization
Nonprofit Organization Innate Immune Network
Division name
Secretariat
Zip code
761-0301
Address
Bio Research Laboratory, 3rd Floor, FROM Kagawa, 2217-16 Hayashi-cho, Takamatsu City, Kagawa
TEL
087-813-9201
Homepage URL
npolsinlsin@lsin.org
Sponsor or person
Institute
Nonprofit Organization Innate Immune Network
Institute
Department
Personal name
Funding Source
Organization
Macrophi Inc.
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,Innate Immune Network
Address
Bio Research Laboratory, 3rd Floor, FROM Kagawa, 2217-16 Hayashi-cho, Takamatsu City, Kagawa
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
那珂川病院（福岡）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | 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
| 2025 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 09 | 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
| 2025 | Year | 05 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066313
