A Study for the Effect of a Food Containing Bifidobacterium on Blood Pressure A Randomized, Double-blind, Placebo-controlled, Parallel-group Study

A Study for the Effect of a Food Containing Bifidobacterium on Blood Pressure A Randomized, Double-blind, Placebo-controlled, Parallel-group Study - A Study for the Effect of a Food Containing Bifidobacterium on Blood Pressure

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000041447

Enrollment

110

Registered

2021-08-16

Start date

2020-08-28

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

Healthy adults

Interventions

Participants will intake one active capsule per day for twelve weeks. They will also get clinical tests before and 4, 8, 12 weeks after the beginning of the intervention. Participants will intake one

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects with diastolic blood pressure of 85-89 mmHg or systolic blood pressure of 130-139 mmHg at clinic.

Exclusion criteria

Exclusion criteria: 1. Subjects who have a disease and are receiving continuous pharmaceutical treatment 2. Subjects with prior receipt of any continuous pharmaceutical treatment, aiming to cure a symptom, less than a month before enrolment (excluding medicine for common cold and pollen allergy) 3. Subjects with current alcohol/drug abuse and receiving treatment; or those with previous history of alcohol/drug abuse 4. Subjects with previous and/or current medical history of serious disease (e.g. liver, kidney, heart, lung, blood) 5. Subjects with prevalence of digestive system comorbidities and previous medical history of the system 6. Subjects with serious anemia 7. Subjects with a risk of presenting allergic reaction to test capsule, other food, and medicine 8. Females who are pregnant and/or lactating, or those with willingness/intention to become pregnant during the study 9. Subjects that plan to have irregular life cycle (e.g. midnight shift work, travel) and/or those with extremely irregular dining and sleep habits 10. Subjects with planned or prior (less than 3 months) continuous receipt of any food/functional food/supplement claiming an effect on blood pressure improvement 11. Subjects that cannot restrict themselves from taking yogurt, fermented milk, or food/intestinal medicine/supplement that contain effective microorganisms (e.g. Lactobacillus, Bifidobacterium), or functional food/supplement that effect intestinal environment (e.g. oligosaccharide, dietary fiber) 12. Subjects that cannot maintain their usual amount and frequency of alcohol intake 13. Subjects with current or past (less than 3 months) experience of participating in other clinical studies 14. Subjects with current or past (less than 1 month) history of smoking

Design outcomes

Primary

Measure	Time frame
Blood pressure Amount of salt intake Questionnaire	—

Secondary

Measure	Time frame
SNPs Safety	—

Countries

Japan

Contacts

Public ContactShoko Sassa

DeNA Life Science, Inc MYCODE service Dept

IRB_dis@dena.com0343667219

Outcome results

None listed

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