Effect of Probiotics on Blood Pressure Management

Hypertension Clinical Trial

Official title:

Role of Probiotics in the Prevention of Hypertension

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03973710
• Other study ID #: ProHealth-2
• Status: Suspended
• Phase: N/A
• Start date: June 3, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• Lactobacillus paracasei dietary supplement
a commercial probiotic dietary supplement
• Placebo controls
placebo with a similar appearance to probiotics supplement

Locations

Country	Name	City	State
China	Department of Nutrition and Food Hygiene	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of systolic blood pressure	changes of systolic blood pressure	baseline, 4 weeks, 8 weeks and 12 weeks
Primary	changes of diastolic blood pressure	changes of diastolic blood pressure	baseline, 4 weeks, 8 weeks and 12 weeks
Primary	changes of gut microbiota	changes of gut microbiota by metagenomics	baseline, 4 weeks, 8 weeks and 12 weeks
Secondary	changes of pulse wave velocity	changes of pulse wave velocity	baseline and after 12-week intervention
Secondary	changes of ankle brachial index	changes of ankle brachial index	baseline and after 12-week intervention
Secondary	changes of microbial metabolite	changes of microbial metabolite by untargeted metabolomics	baseline and after 12-week intervention