Effect of Probiotics on Lipid 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 of hypercholesterolemia in both humans and animal models. Probiotics have been reported to have ameliorative effects in murine models. However, whether probiotics could help alleviate dyslipidemia 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 lipid management in Chinese adults. By understanding the mechanism by which probiotics exert the beneficial effects, we can better control the rising prevalence of hypercholesterolemia, which is a major risk factor for cardiovascular diseases.

Official Title
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Role of Probiotics in the Management of Hypercholesterolemia

Conditions
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Primary Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Lactobacillus paracasei dietary supplement
* Other: 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 primary hypercholesterolemia who has a total cholesterol level of 5.18 mmol/L or higher and/ or an LDL cholesterol level of 2.59 mmol/L or higher; Absence of any diet, dietary supplement and medication that might interfere with lipid homoeostasis and gut microbiota, especially antibiotics and probiotics. Exclusion Criteria: Triglyceride levels higher than 3.95 mmol/L, or 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
Interventional Model Description: placebo-controlled, randomized clinical trial
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. | Other: 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 |
| --- | --- | --- |
| Total cholesterol | changes of total cholesterol levels in plasma by automatic biochemical analyzer | baseline, 4 weeks, 8 weeks and 12 weeks | 
| LDL-cholesterol | changes of LDL-cholesterol levels in plasma by automatic biochemical analyzer | baseline, 4 weeks, 8 weeks and 12 weeks | 
| Triglyceride | changes of triglyceride levels in plasma by automatic biochemical analyzer | baseline, 4 weeks, 8 weeks and 12 weeks | 
| non HDL-cholesterol | changes of non HDL-cholesterol levels in plasma | baseline, 4 weeks, 8 weeks and 12 weeks | 
| gut microbiota | changes of gut microbiota by metagenomics | baseline, 4 week, 8 weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | changes of blood pressure | baseline, 4 week, 8 week and 12 weeks | 
| pulse wave velocity | changes of pulse wave velocity by VP-1000plus from Omron | baseline and after 12-week intervention | 
| ankle Brachial Index | changes of ankle Brachial Index by VP-1000plus from Omron | baseline and after 12-week intervention | 
| 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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Primary Hypercholesterolemia, Probiotics, Cardiovascular risk