Cardiometabolic Risk Factors
Conditions
Brief summary
Atherosclerosis is a major risk factor for cardiovascular diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of atherosclerosis. Animal studies have demonstrated that administration of probiotics help delay the progression of atherosclerosis through several mechanisms. This trial aims to examine its protective effect in humans.
Detailed description
Atherosclerosis is a major risk factor for cardiovascular diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of atherosclerosis. Animal studies have demonstrated that administration of probiotics help delay the progression of atherosclerosis through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids. However, whether administration of probiotics also has a protective effect in subjects with metabolic syndrome (MetS), who are at high risk for developing atherosclerosis, remain unknown.
Interventions
DIETARY_SUPPLEMENTProbiotics
During the study period, subjects are instructed to take one capsule of probiotics daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.
DIETARY_SUPPLEMENTPlacebo control
During the study period, subjects are instructed to take one capsule of placebo control daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Local residents aged between 30-60 years old; * Stable weight (\<5% weight change over last 3 months); * Central obesity defined as waist circumference ≥90 cm in males or ≥80 cm in females, Plus any two of the following four conditions i) Elevated triglycerides: serum triglycerides ≥150 mg/dL (1.7 mmol/L); ii) Reduced HDL cholesterol: serum HDL-c \<40 mg/dL (1.03 mmol/L) in males or \<50 mg/dL (1.29 mmol/L) in females; iii) Elevated blood pressure: systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; iv) Elevated fasting plasma glucose: fasting plasma glucose ≥100 mg/dL (5.6 mmol/L) * Absence of any systemic, cardiovascular diseases, as well as infections within the previous month; * Absence of any diet or medication that might interfere with metabolic homoeostasis and gut microbiota, especially antibiotics and probiotics 4 weeks before recruitment.
Exclusion criteria
* Acute illness or current evidence of acute or chronic inflammatory of infective diseases; * Participation in regular diet 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 |
|---|---|---|
| Flow-mediated slowing (FMS) | from baseline to 12 weeks after intervention | FMS is a simple test for endothelial functions measured by Vicorder. In patients whose endothelial function or flow-mediated vasodilation are compromised, the FMS is substantially reduced. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| microbial metabolites | from baseline to 12 weeks after intervention | alterations of microbial metabolites evaluated by High performance liquid chromatography-mass spectrometry |
| Metabolic Syndrome Severity Z Score (MetZ score) | from baseline to 12 weeks after intervention | MetZ score is an weighted score of the five traditional components of Metabolic syndrome (waist, triglyceride, HDL cholesterol, SBP and fasting glucose). It's used to evaluate the severity of metabolic disorder, and a higher score indicates a more severe status. |
| gut microbiota | from baseline to 12 weeks after intervention | Alterations of the composition of gut microbiota evaluated by metagenomics |
| Blood pressure | from baseline to 12 weeks after intervention | alterations of blood pressure |
| Insulin sensitivity | from baseline to 12 weeks after intervention | alterations of HOMA-IR index |
| Lipid profiles | from baseline to 12 weeks after intervention | alterations of blood lipids including total cholesterol, triglyceride, LDL cholesterol and HDL cholesterol determined by automatic biochemical analyser |
Countries
China
Outcome results
None listed