Primary Hypercholesterolemia
Conditions
Keywords
Primary Hypercholesterolemia, Probiotics, Cardiovascular risk
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus paracasei dietary supplement
a commercial probiotic dietary supplement
OTHERPlacebo controls
placebo with a similar appearance to probiotics supplement
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, investigators and care providers at the scene are all blinded to the allocation of treatment group. Data collected will be analyzed by another investigator who is blinded to the study design.
Intervention model description
placebo-controlled, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| gut microbiota | baseline, 4 week, 8 weeks and 12 weeks | changes of gut microbiota by metagenomics |
| 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 |
| Triglyceride | baseline, 4 weeks, 8 weeks and 12 weeks | changes of triglyceride levels in plasma by automatic biochemical analyzer |
| non HDL-cholesterol | baseline, 4 weeks, 8 weeks and 12 weeks | changes of non HDL-cholesterol levels in plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| ankle Brachial Index | baseline and after 12-week intervention | changes of ankle Brachial Index by VP-1000plus from Omron |
| microbial metabolite | baseline and after 12-week intervention | changes of microbial metabolite by untargeted metabolomics |
Countries
China
Outcome results
None listed