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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | Subjects are instructed to take one capsule of probiotics daily for a total of 3 months |
|
| Placebo Control | Placebo Comparator | Subjects are instructed to take one capsule of placebo daily for a total of 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from baseline to 12 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| gut microbiota | Alterations of the composition of gut microbiota evaluated by metagenomics | from baseline to 12 weeks after intervention |
| microbial metabolites | alterations of microbial metabolites evaluated by High performance liquid chromatography-mass spectrometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition and Food Hygiene | Guangzhou | Guangdong | 510080 | China | ||
| Sun Yat-Sen University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37506599 | Derived | Yang J, Huang J, Huang Z, Xu Y, Li W, Zhu S, Zhao Y, Ye B, Liu L, Zhu J, Xia M, Liu Y. Cardiometabolic benefits of Lacticaseibacillus paracasei 8700:2: A randomized double-blind placebo-controlled trial. Clin Nutr. 2023 Sep;42(9):1637-1646. doi: 10.1016/j.clnu.2023.07.017. Epub 2023 Jul 21. |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| Placebo control | Dietary Supplement | 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. |
|
| 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. | 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 | from baseline to 12 weeks after intervention |
| Blood pressure | alterations of blood pressure | from baseline to 12 weeks after intervention |
| Insulin sensitivity | alterations of HOMA-IR index | from baseline to 12 weeks after intervention |
| Guangzhou |
| Guangdong |
| 510080 |
| China |
| D019602 |
| Food and Beverages |