Effect of Probiotics on Lipid Management

Role of Probiotics in the Management of Hypercholesterolemia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: Lactobacillus paracasei dietary supplement; Other: Placebo controls

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Department of Nutrition and Food Hygiene

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics group; 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; a commercial probiotic dietary supplement
Placebo Comparator: Placebo group; Participants will be given capsules containing microcrystalline cellulose once daily for 12 weeks followed by comprehensive physical and clinical examinations.	Other: Placebo controls; placebo with a similar appearance to probiotics supplement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Min Xia, PhD, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 12, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Probiotics; Cardiovascular risk; Primary Hypercholesterolemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: ProHealth-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No