Effect of Probiotics on Cardiometabolic Health

Cardiometabolic Risk Factors Clinical Trial

Official title:

An Interventional Study for the Beneficial Effects of Probiotics on Cardio-metabolic Health in Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005754
• Other study ID #: Pro-2021
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: February 28, 2022

Study information

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

Clinical Trial Summary

Atherosclerosis is a major risk factor for cardiovascular diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of atherosclerosis. Animal studies have demonstrated that administration of probiotics help delay the progression of atherosclerosis through several mechanisms. This trial aims to examine its protective effect in humans.

Description:

Atherosclerosis is a major risk factor for cardiovascular diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of atherosclerosis. Animal studies have demonstrated that administration of probiotics help delay the progression of atherosclerosis through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids.

However, whether administration of probiotics also has a protective effect in subjects with metabolic syndrome (MetS), who are at high risk for developing atherosclerosis, remain unknown.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Local residents aged between 30-60 years old;

• Stable weight (<5% weight change over last 3 months);

• Central obesity defined as waist circumference =90 cm in males or =80 cm in females, Plus any two of the following four conditions i) Elevated triglycerides: serum triglycerides =150 mg/dL (1.7 mmol/L); ii) Reduced HDL cholesterol: serum HDL-c <40 mg/dL (1.03 mmol/L) in males or <50 mg/dL (1.29 mmol/L) in females; iii) Elevated blood pressure: systolic blood pressure =130 mmHg or diastolic blood pressure =85 mmHg; iv) Elevated fasting plasma glucose: fasting plasma glucose =100 mg/dL (5.6 mmol/L)

• Absence of any systemic, cardiovascular diseases, as well as infections within the previous month;

• Absence of any diet or medication that might interfere with metabolic homoeostasis and gut microbiota, especially antibiotics and probiotics 4 weeks before recruitment.

Exclusion Criteria:

• Acute illness or current evidence of acute or chronic inflammatory of infective diseases;

• Participation in regular diet 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

• Cardiometabolic Risk Factors

Intervention

Dietary Supplement:
• Probiotics
During the study period, subjects are instructed to take one capsule of probiotics daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.
• Placebo control
During the study period, subjects are instructed to take one capsule of placebo control daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.

Locations

Country	Name	City	State
China	Department of Nutrition and Food Hygiene	Guangzhou	Guangdong
China	Sun Yat-Sen University	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	Flow-mediated slowing (FMS)	FMS is a simple test for endothelial functions measured by Vicorder. In patients whose endothelial function or flow-mediated vasodilation are compromised, the FMS is substantially reduced.	from baseline to 12 weeks after intervention
Secondary	gut microbiota	Alterations of the composition of gut microbiota evaluated by metagenomics	from baseline to 12 weeks after intervention
Secondary	microbial metabolites	alterations of microbial metabolites evaluated by High performance liquid chromatography-mass spectrometry	from baseline to 12 weeks after intervention
Secondary	Metabolic Syndrome Severity Z Score (MetZ score)	MetZ score is an weighted score of the five traditional components of Metabolic syndrome (waist, triglyceride, HDL cholesterol, SBP and fasting glucose). It's used to evaluate the severity of metabolic disorder, and a higher score indicates a more severe status.	from baseline to 12 weeks after intervention
Secondary	Lipid profiles	alterations of blood lipids including total cholesterol, triglyceride, LDL cholesterol and HDL cholesterol determined by automatic biochemical analyser	from baseline to 12 weeks after intervention
Secondary	Blood pressure	alterations of blood pressure	from baseline to 12 weeks after intervention
Secondary	Insulin sensitivity	alterations of HOMA-IR index	from baseline to 12 weeks after intervention