Effect of Probiotics on Lipid Management
- Conditions
- Primary Hypercholesterolemia
- Interventions
- Other: Placebo controlsDietary Supplement: Lactobacillus paracasei dietary supplement
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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
- Arm && Interventions
Group Intervention Description Placebo group Placebo controls Participants will be given capsules containing microcrystalline cellulose once daily for 12 weeks followed by comprehensive physical and clinical examinations. Probiotics group Lactobacillus paracasei dietary supplement Participants will be given capsules containing Lactobacillus paracasei once daily for 12 weeks followed by comprehensive physical and clinical examinations.
- 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