A Study for the Effect of a Food Containing Bifidobacterium on Blood Pressure A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000041447
- Lead Sponsor
- DeNA Life Science, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 110
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood pressure Amount of salt intake Questionnaire
- Secondary Outcome Measures
Name Time Method SNPs Safety