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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
130
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.
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.
Department of Nutrition and Food Hygiene
Guangzhou, Guangdong, China
Sun Yat-Sen University
Guangzhou, Guangdong, China
Flow-mediated slowing (FMS)
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.
Time frame: from baseline to 12 weeks after intervention
gut microbiota
Alterations of the composition of gut microbiota evaluated by metagenomics
Time frame: from baseline to 12 weeks after intervention
microbial metabolites
alterations of microbial metabolites evaluated by High performance liquid chromatography-mass spectrometry
Time frame: from baseline to 12 weeks after intervention
Metabolic Syndrome Severity Z Score (MetZ score)
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.
Time frame: from baseline to 12 weeks after intervention
Lipid profiles
alterations of blood lipids including total cholesterol, triglyceride, LDL cholesterol and HDL cholesterol determined by automatic biochemical analyser
Time frame: from baseline to 12 weeks after intervention
Blood pressure
alterations of blood pressure
Time frame: from baseline to 12 weeks after intervention
Insulin sensitivity
alterations of HOMA-IR index
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: from baseline to 12 weeks after intervention