Clinical trial NCT03952169: Effect of Probiotics on Lipid Management
Official title: Role of Probiotics in the Management of Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Hypercholesterolemia
Keywords: Primary Hypercholesterolemia
Probiotics
Cardiovascular risk
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo-controlled, randomized clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total cholesterol
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: LDL-cholesterol
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: Triglyceride
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: non HDL-cholesterol
timeFrame: baseline, 4 weeks, 8 weeks and 12 weeks
measure: gut microbiota
timeFrame: baseline, 4 week, 8 weeks and 12 weeks
Secondary outcomes:
measure: blood pressure
timeFrame: baseline, 4 week, 8 week and 12 weeks
measure: pulse wave velocity
timeFrame: baseline and after 12-week intervention
measure: ankle Brachial Index
timeFrame: baseline and after 12-week intervention
measure: microbial metabolite
timeFrame: baseline and after 12-week intervention
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nutrition and Food Hygiene
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Min Xia, PhD
role: PRINCIPAL_INVESTIGATOR
References: