Effect of Probiotics on Blood Pressure Management

Not Applicable

Suspended

• Conditions: Hypertension
• Interventions: Dietary Supplement: Lactobacillus paracasei dietary supplement; Dietary Supplement: Placebo controls

• Registration Number: NCT03973710
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-04
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-09
• Study Start: 2022-06-03
• Primary Completion: 2023-03-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics group	Lactobacillus paracasei dietary supplement	Participants will be given capsules containing Lactobacillus paracasei once daily for 12 weeks followed by comprehensive physical and clinical examinations.
Placebo group	Placebo controls	Participants will be given capsules containing microcrystalline cellulose once daily for 12 weeks followed by comprehensive physical and clinical examinations.

Primary Outcome Measures

Name	Time	Method
changes of gut microbiota	baseline, 4 weeks, 8 weeks and 12 weeks	changes of gut microbiota by metagenomics
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Nutrition and Food Hygiene; 🇨🇳 Guangzhou, Guangdong, China