UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063264 |
|---|---|
| Receipt number | R000072323 |
| Scientific Title | Effects of intake of food containing Bifidobacterium animalis subsp. lactis LKM512 and arginine on cognitive function: A randomized, double-blind, placebo-controlled trial |
| Date of disclosure of the study information | 2026/10/13 |
| Last modified on | 2026/10/13 23:14:43 |
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Basic information
Public title
A study to investigate the effects of food containing Bifidobacterium LKM512 and arginine on cognitive function: A randomized, double-blind, placebo-controlled trial
Acronym
A study to investigate the effects of food containing Bifidobacterium LKM512 and arginine on cognitive function
Scientific Title
Effects of intake of food containing Bifidobacterium animalis subsp. lactis LKM512 and arginine on cognitive function: A randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym
Effects of intake of food containing Bifidobacterium animalis subsp. lactis LKM512 and arginine on cognitive function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of consuming food containing Bifidobacterium animalis subsp. lactis LKM512 and arginine on cognitive function in healthy middle-aged and older adults.
Basic objectives2
Others
Basic objectives -Others
Fecal and blood samples will be collected to analyze factors related to the gut microbiota-gut-brain axis, including polyamines, in order to explore the underlying mechanisms of action.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitrax assessment
Semantic verbal fluency test
FNAME (Face-Name Associative Memory Exam), modified for use in Japanese participants
NowKNOW cognitive function assessment (https://nouknow.jp/)
Key secondary outcomes
Blood biochemical parameters
Faecal microbiome and metabolome, focusing on physiologically active substances such as polyamines
Blood metabolite profiles
Blood lymphocyte profiles
Measurements obtained using an advanced glycation end-products (AGEs) sensor
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
Participants will intake 3 g of a powdered food containing at least 1 x 10^9 CFU of Bifidobacterium animalis subsp. lactis LKM512 and 600 mg of arginine once daily for 16 weeks.
Interventions/Control_2
Participants will intake 3 g of a powdered food (placebo) containing only excipients, without Bifidobacterium animalis subsp. lactis LKM512 or arginine, once daily for 16 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
| 40 | years-old | <= |
Age-upper limit
| 79 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese men and women aged 40 years or older but younger than 79 years.
2. Healthy individuals who can perform activities of daily living without difficulty.
3. Individuals who subjectively perceive a decline in their memory.
4. Individuals who have received a sufficient explanation of the purpose and procedures of the study, fully understood the information provided, voluntarily agreed to participate, and provided written informed consent.
Key exclusion criteria
1. Individuals with suspected dementia (defined as a MMSE score of 23 or lower).
2. Individuals with current or previous psychiatric disorders or sleep disorders.
3. Individuals with current or previous neurological or cerebrovascular diseases.
4. Individuals with current or previous serious underlying diseases, including diabetes mellitus, liver disease, kidney disease, or heart disease.
5. Individuals who regularly consume supplements, functional foods, or medications that may affect cognitive function, or who have consumed them within 3 months before providing informed consent.
6. Individuals undergoing treatment for brain function-related conditions or receiving prescribed medications related to brain function, including traditional Japanese Kampo medicines.
7. Individuals with current or previous drug or food allergies.
8. Individuals with diseases requiring continuous medication.
9. Individuals who regularly consume yogurt, lactic acid bacteria beverages, supplements, or other products containing probiotics or prebiotics, or who have consumed such products within 3 months before providing informed consent.
10. Individuals who have donated apheresis blood before the start of the study.
11. Individuals who have donated 400 mL of whole blood within 4 months before the start of the study.
12. Individuals who participated in or are currently participating in another clinical trial or clinical study within 1 month before providing informed consent.
13. Individuals who are currently pregnant or breastfeeding, or who intend to become pregnant during the study period.
14. Individuals who habitually consume excessive amounts of alcohol (equivalent to 60 g or more of pure alcohol/day).
15. Individuals with extremely irregular eating habits or irregular daily routines, including shift workers.
16. Individuals who smoke.
17. Individuals who are deemed unsuitable for participation in this study by the principal investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mitsuharu |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyodo Milk Industry Co. Ltd.
Division name
Research Laboratories
Zip code
190-0182
Address
20-1 Hirai, Hinode-machi, Nishitama-gun, Tokyo, Japan
TEL
+81-42-597-5911
m-matumoto@meito.co.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takahama |
Organization
Seishukai Clinic
Division name
Clinical trial office
Zip code
111-0036
Address
3-18-5 Matsugaya, Taito-ku, Tokyo, Japan
TEL
+81-80-4410-9269
Homepage URL
t-takahama@seishukai.or.jp
Sponsor or person
Institute
Research Laboratories, Kyodo Milk Industry Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Research Laboratories, Kyodo Milk Industry 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
Seishukai Clinic Institutional Review Board
Address
3-18-5 Matsugaya, Taito-ku, Tokyo
Tel
08044109269
t-takahama@seishukai.or.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
| 2026 | Year | 10 | Month | 13 | 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
| 2026 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 13 | Day |
Last modified on
| 2026 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072323
