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Dysbiosis of gut microbiota has been reported to be involved in the development and progression of hypertension in both humans and animal models. Probiotics have been reported to have ameliorative effects in murine models. However, whether probiotics could help alleviate hypertension 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 the prevention of hypertension in Chinese adults. By understanding the mechanisms by which probiotics exert this beneficial effects, we can better control the rising prevalence of hypertension, 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus paracasei dietary supplement | Dietary Supplement | a commercial probiotic dietary supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes of systolic blood pressure | changes of systolic blood pressure | baseline, 4 weeks, 8 weeks and 12 weeks |
| changes of diastolic blood pressure | changes of diastolic blood pressure | baseline, 4 weeks, 8 weeks and 12 weeks |
| changes of gut microbiota | changes of gut microbiota by metagenomics | baseline, 4 weeks, 8 weeks and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| changes of pulse wave velocity | changes of pulse wave velocity | baseline and after 12-week intervention |
| changes of ankle brachial index | changes of ankle brachial index |
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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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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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 | Dietary Supplement | placebo with a similar appearance to probiotics supplement |
|
| baseline and after 12-week intervention |
| changes of microbial metabolite | changes of microbial metabolite by untargeted metabolomics | baseline and after 12-week intervention |