UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058095 |
|---|---|
| Receipt number | R000066376 |
| Scientific Title | A double-blind, placebo-controlled study to evaluate the effects of a food containing Bifidobacterium animalis subsp. lactis LKM512 and arginine on vascular endothelial function and blood pressure. |
| Date of disclosure of the study information | 2025/06/08 |
| Last modified on | 2025/06/05 17:37:01 |
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Basic information
Public title
A study on the effects of food containing the probiotic Bifidobacterium LKM512 and arginine on vascular endothelial function and blood pressure
Acronym
A study on the effects of food containing the probiotic Bifidobacterium LKM512 and arginine on vascular endothelial function and blood pressure
Scientific Title
A double-blind, placebo-controlled study to evaluate the effects of a food containing Bifidobacterium animalis subsp. lactis LKM512 and arginine on vascular endothelial function and blood pressure.
Scientific Title:Acronym
A double-blind, placebo-controlled study to evaluate the effects of a food containing Bifidobacterium LKM512 and arginine on vascular endothelial function and blood pressure.
Region
| Japan |
Condition
Condition
Arteriosclerosis (Subclinical stage)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of oral administration of a food containing probiotic Bifidobacterium LKM512 and arginine on vascular endothelial function in individuals at a subclinical stage of arteriosclerosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Flow-mediated dilation (FMD) value
Blood pressure
Key secondary outcomes
Blood biochemical data
Fecal microbiome and metabolome data
Blood plasma metabolome
BMI
Waist circumference
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants receive a 16-week daily intake of 3 g of a food product containing Bifidobacterium LKM512 (approximately 1 billion viable bacterial cells) and 600 mg of arginine.
Interventions/Control_2
Participants in the placebo group receive a 16-week daily intake of 3 g of a food product that contains neither Bifidobacterium LKM512 nor arginine.
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese men and women aged between 35 and 64 years
2. Body-mass index (BMI) >=25.0 kg/m2
3. Individuals who voluntarily agreed to participate in the study after receiving sufficient explanation and providing written informed consent
Key exclusion criteria
1. Individuals who currently require medication or regular medical visits
2. Individuals undergoing dietary or exercise therapy under medical supervision
3. Individuals with current or past history of serious diseases
4. Individuals who regularly consume over-the-counter medications, quasi-drugs, dietary supplements, or foods with health claims such as Foods for Specified Health Uses (FOSHU) or Foods with Functional Claims (FFC); however, those who are able to discontinue such use after giving consent may be eligible to participate.
5. Individuals with drug or food allergies
6. Individuals who have donated blood components or 200 mL of whole blood within one month prior to the start of the study
7. Individuals who have donated 400 mL of whole blood within four months prior to the start of the study
8. Individuals who have participated in other clinical trials or clinical studies within one month prior to obtaining informed consent, are currently participating, or plan to participate during the study period.
9. Women who are currently pregnant or breastfeeding, or who plan to become pregnant during the study period.
10. Individuals with habitual excessive alcohol consumption (>=60 grams of ethanol per day)
11. Individuals with irregular lifestyles, including those with highly irregular eating habits, shift work, or night shifts
12. Individuals with a smoking habit
13. Individuals judged by the principal medical doctor to be inappropriate for participation in the study
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
TEL
042-597-5911
m-matumoto@metio.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
TEL
080-4410-9269
Homepage URL
t-takahama@seishukai.or.jp
Sponsor or person
Institute
Kyodo Milk Industry Co. Ltd., Research Laboratories
Institute
Department
Personal name
Funding Source
Organization
Kyodo Milk Industry Co. Ltd., Research Laboratories
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
The University of Tokyo, Institute of Medical Science
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
080-4410-9269
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
| 2025 | Year | 06 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 11 | 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 | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066376
