Effect of Probiotics on Lipid Management

Not Applicable

• Conditions: Primary Hypercholesterolemia

• Registration Number: NCT03952169
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-05-12
• Study First Submitted: 2019-05-12
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-05
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Triglyceride	baseline, 4 weeks, 8 weeks and 12 weeks	changes of triglyceride levels in plasma by automatic biochemical analyzer
Total cholesterol	baseline, 4 weeks, 8 weeks and 12 weeks	changes of total cholesterol levels in plasma by automatic biochemical analyzer
LDL-cholesterol	baseline, 4 weeks, 8 weeks and 12 weeks	changes of LDL-cholesterol levels in plasma by automatic biochemical analyzer
gut microbiota	baseline, 4 week, 8 weeks and 12 weeks	changes of gut microbiota by metagenomics
non HDL-cholesterol	baseline, 4 weeks, 8 weeks and 12 weeks	changes of non HDL-cholesterol levels in plasma

Secondary Outcome Measures

Name	Time	Method
blood pressure	baseline, 4 week, 8 week and 12 weeks	changes of blood pressure
pulse wave velocity	baseline and after 12-week intervention	changes of pulse wave velocity by VP-1000plus from Omron
microbial metabolite	baseline and after 12-week intervention	changes of microbial metabolite by untargeted metabolomics
ankle Brachial Index	baseline and after 12-week intervention	changes of ankle Brachial Index by VP-1000plus from Omron

Trial Locations

Locations (1)

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