Arteriosclerosis (Subclinical stage)
Conditions
Interventions
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.
Participants in the plac
Sponsors
Kyodo Milk Industry Co. Ltd., Research Laboratories
The University of Tokyo, Institute of Medical Science
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flow-mediated dilation (FMD) value Blood pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood biochemical data Fecal microbiome and metabolome data Blood plasma metabolome BMI Waist circumference | — |
Countries
Japan
Contacts
Public ContactTsuyoshi Takahama
Seishukai Clinic Clinical trial office
Outcome results
None listed