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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics group | Experimental | Participants will be given capsules containing Lactobacillus paracasei once daily for 12 weeks followed by comprehensive physical and clinical examinations. |
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| Placebo group | Placebo Comparator | Participants will be given capsules containing microcrystalline cellulose once daily for 12 weeks followed by comprehensive physical and clinical examinations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus paracasei dietary supplement | Dietary Supplement | a commercial probiotic dietary supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total cholesterol | changes of total cholesterol levels in plasma by automatic biochemical analyzer | baseline, 4 weeks, 8 weeks and 12 weeks |
| LDL-cholesterol | changes of LDL-cholesterol levels in plasma by automatic biochemical analyzer | baseline, 4 weeks, 8 weeks and 12 weeks |
| Triglyceride | changes of triglyceride levels in plasma by automatic biochemical analyzer | baseline, 4 weeks, 8 weeks and 12 weeks |
| non HDL-cholesterol | changes of non HDL-cholesterol levels in plasma | baseline, 4 weeks, 8 weeks and 12 weeks |
| gut microbiota | changes of gut microbiota by metagenomics | baseline, 4 week, 8 weeks and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure | changes of blood pressure | baseline, 4 week, 8 week and 12 weeks |
| pulse wave velocity | changes of pulse wave velocity by VP-1000plus from Omron |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Xia, PhD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition and Food Hygiene | Guangzhou | Guangdong | 510080 | China |
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placebo-controlled, randomized clinical trial
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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.
| Placebo controls | Other | placebo with a similar appearance to probiotics supplement |
|
| baseline and after 12-week intervention |
| ankle Brachial Index | changes of ankle Brachial Index by VP-1000plus from Omron | baseline and after 12-week intervention |
| microbial metabolite | changes of microbial metabolite by untargeted metabolomics | baseline and after 12-week intervention |