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Effects of yogurt containing probiotic bifidobacterium LKM512 and arginine on vascular endothelial function and blood pressure

An open-label,\x{00a0}single-arm study to evaluate the efficacy of yogurt containing probiotic bifidobacterium LKM512 and arginine on vascular endothelial function and blood pressure - An open-label,\x{00a0}single-arm study to evaluate the efficacy of yogurt containing probiotic bifidobacterium LKM512 and arginine on vascular endothelial function and blood pressure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049792
Enrollment
60
Registered
2023-01-01
Start date
2022-12-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Individuals with preclinical stage of arteriosclerosis

Interventions

The participants are given a 16-week treatment with 100 g yogurt containing bifidobacterium LKM512 (approximately 1 billion viable bacterial cells) and arginine (600 mg) once a day.

Sponsors

Kyodo Milk Industry Co., Ltd.
Lead Sponsor
The University of Tokyo, Institute of Medical Science,\x{00a0}Prof. Toru Suzuki
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria:

Exclusion criteria

Exclusion criteria: 1. Participants who take a medicine, or visit the hospital for disease 2. Participants who are undergoing diet therapy or exercise therapy under medical supervision 3. Participants with current or past history of serious illness 4. Participants who can't stop taking over-the-counter drugs, quasi-drugs, and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) 5. Participants who have drug or food allergies 6. Participants who donated component blood or 200 ml of whole blood within 1 month prior to the start of this study 7. Participants who donated 400 ml of whole blood within 4 months prior to the start of this study 8. Participants who have participated or are participating in other clinical study within one month prior to the obtaining consent, or those who plan to participate during the study period 9. Participants who are pregnant or breastfeeding, or those who might become pregnant during the study period 10. Participants who drink a lot of alcohol (60 g/day, the volume of pure alcohol) 11. Participants who have an irregular life rhythm, such as those who have extremely irregular eating habits, those who are shift workers, or those who work the graveyard shift 12. Inappropriate cases evaluated by medical doctors

Design outcomes

Primary

MeasureTime frame
Flow-mediated dilation (FMD) value Blood pressure

Secondary

MeasureTime frame
BMI Waist circumference Hematological test, blood biochemical test Fecal data (fecal microbiome; metabolites such as polyamines and trimethylamine)

Countries

Japan

Contacts

Public ContactTakahama Tsuyoshi

Seishukai Clinic Clinical trial office

t-takahama@seishukai.or.jp080-4410-9269

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026