Effect of Probiotics on Lipid Management

Primary Hypercholesterolemia Clinical Trial

Official title:

Role of Probiotics in the Management of Hypercholesterolemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03952169
• Other study ID #: ProHealth-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 12, 2019
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia
• Primary Hypercholesterolemia

Intervention

Dietary Supplement:
• Lactobacillus paracasei dietary supplement
a commercial probiotic dietary supplement

Other:
• Placebo controls
placebo with a similar appearance to probiotics supplement

Locations

Country	Name	City	State
China	Department of Nutrition and Food Hygiene	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cholesterol	changes of total cholesterol levels in plasma by automatic biochemical analyzer	baseline, 4 weeks, 8 weeks and 12 weeks
Primary	LDL-cholesterol	changes of LDL-cholesterol levels in plasma by automatic biochemical analyzer	baseline, 4 weeks, 8 weeks and 12 weeks
Primary	Triglyceride	changes of triglyceride levels in plasma by automatic biochemical analyzer	baseline, 4 weeks, 8 weeks and 12 weeks
Primary	non HDL-cholesterol	changes of non HDL-cholesterol levels in plasma	baseline, 4 weeks, 8 weeks and 12 weeks
Primary	gut microbiota	changes of gut microbiota by metagenomics	baseline, 4 week, 8 weeks and 12 weeks
Secondary	blood pressure	changes of blood pressure	baseline, 4 week, 8 week and 12 weeks
Secondary	pulse wave velocity	changes of pulse wave velocity by VP-1000plus from Omron	baseline and after 12-week intervention
Secondary	ankle Brachial Index	changes of ankle Brachial Index by VP-1000plus from Omron	baseline and after 12-week intervention
Secondary	microbial metabolite	changes of microbial metabolite by untargeted metabolomics	baseline and after 12-week intervention