Hypertension
Conditions
Keywords
Probiotics, Prevention, Hypertension
Brief summary
Dysbiosis of gut microbiota has been reported to be involved in the development and progression of hypertension in both humans and animal models. Probiotics have been reported to have ameliorative effects in murine models. However, whether probiotics could help alleviate hypertension in adults remain obscure.
Detailed description
Probiotics are live microorganisms that have been associated with multiple health benefits. However, its protective role in adults has long been controversial. This study aims to examine the effect of 12-week probiotics supplementation on the prevention of hypertension in Chinese adults. By understanding the mechanisms by which probiotics exert this beneficial effects, we can better control the rising prevalence of hypertension, which is a major risk factor for cardiovascular diseases.
Interventions
DIETARY_SUPPLEMENTLactobacillus paracasei dietary supplement
a commercial probiotic dietary supplement
DIETARY_SUPPLEMENTPlacebo controls
placebo with a similar appearance to probiotics supplement
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, investigators and care providers at the scene are all blinded to the allocation of treatment group. Data collected will be analyzed by another investigator who is blinded to the study design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Eligible subjects include men and women 18 to 75 years of age with pre-hypertension who has a systemic blood between 120 and 139 mmHg and/ or a diastolic blood pressure between 80 and 80 mmHg; * Absence of any diet, dietary supplement and medications that might interfere with blood pressure and gut microbiota, especially antibiotics and probiotics.
Exclusion criteria
* Any other systemic, metabolic and cardiovascular or cerebrovascular diseases; * Type 1 diabetes, type 2 diabetes treated with insulin or other medications; * Acute illness or current evidence of acute or chronic inflammatory or infective diseases; * Participation in any diet or lifestyle program more than 2 times per week in the latest 3 months prior to recruitment; * Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes of systolic blood pressure | baseline, 4 weeks, 8 weeks and 12 weeks | changes of systolic blood pressure |
| changes of diastolic blood pressure | baseline, 4 weeks, 8 weeks and 12 weeks | changes of diastolic blood pressure |
| changes of gut microbiota | baseline, 4 weeks, 8 weeks and 12 weeks | changes of gut microbiota by metagenomics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes of pulse wave velocity | baseline and after 12-week intervention | changes of pulse wave velocity |
| changes of ankle brachial index | baseline and after 12-week intervention | changes of ankle brachial index |
| changes of microbial metabolite | baseline and after 12-week intervention | changes of microbial metabolite by untargeted metabolomics |
Countries
China
Outcome results
None listed