Effect of Probiotics on Cardiometabolic Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cardiometabolic Risk Factors

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Dietary Supplement: Placebo control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 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<br>Subjects are instructed to take one capsule of probiotics daily for a total of 3 months | Dietary Supplement: Probiotics<br>* 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.<br>|
| Placebo Comparator: Placebo Control<br>Subjects are instructed to take one capsule of placebo daily for a total of 3 months | Dietary Supplement: Placebo control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gut microbiota | Alterations of the composition of gut microbiota evaluated by metagenomics | from baseline to 12 weeks after intervention | 
| microbial metabolites | alterations of microbial metabolites evaluated by High performance liquid chromatography-mass spectrometry | from baseline to 12 weeks after intervention | 
| 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 | 
| 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 | 
| Blood pressure | alterations of blood pressure | from baseline to 12 weeks after intervention | 
| Insulin sensitivity | alterations of HOMA-IR index | from baseline to 12 weeks after intervention |