Effect of Probiotics on Blood Pressure Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of Probiotics in the Prevention of Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: Lactobacillus paracasei dietary supplement
* Dietary Supplement: Placebo controls


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics group<br>Participants will be given capsules containing Lactobacillus paracasei once daily for 12 weeks followed by comprehensive physical and clinical examinations. | Dietary Supplement: Lactobacillus paracasei dietary supplement<br>* a commercial probiotic dietary supplement<br>|
| Placebo Comparator: Placebo group<br>Participants will be given capsules containing microcrystalline cellulose once daily for 12 weeks followed by comprehensive physical and clinical examinations. | Dietary Supplement: Placebo controls<br>* placebo with a similar appearance to probiotics supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of systolic blood pressure | changes of systolic blood pressure | baseline, 4 weeks, 8 weeks and 12 weeks | 
| changes of diastolic blood pressure | changes of diastolic blood pressure | baseline, 4 weeks, 8 weeks and 12 weeks | 
| changes of gut microbiota | changes of gut microbiota by metagenomics | baseline, 4 weeks, 8 weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of pulse wave velocity | changes of pulse wave velocity | baseline and after 12-week intervention | 
| changes of ankle brachial index | changes of ankle brachial index | baseline and after 12-week intervention | 
| changes of microbial metabolite | changes of microbial metabolite by untargeted metabolomics | baseline and after 12-week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Prevention, Hypertension