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This survey is designed to investigate the effect of highland barley β-glucan supplementation on the regulatory of blood pressure, gut microbiota and cardiovascular risk fators in subjects with hypertention.
Highland barley β-glucan belongs to the group of prebiotics and has been found to be associated with multiple health benefits. However, its protective role in subjects with hypertension are remain unclear. This study aims to examine the effect of 12-week prebiotics supplementation on blood pressure management in subjects with hypertension. By understanding the mechanism by which prebiotics exert the 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 |
|---|---|---|---|
| Highland barley β-glucan group | Experimental | Participants will be given oral liquids mainly containing highland barley β-glucan once daily for 12 weeks followed by comprehensive physical and clinical examinations. |
|
| Placebo group | Placebo Comparator | Participants will be given oral liquids mainly containing Corn starch once daily for 12 weeks followed by comprehensive physical and clinical examinations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Highland barley β-glucan dietary supplement | Dietary Supplement | 100 mL oral liquid mainly containing highland barley β-glucan once daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes of systolic blood pressure | changes of systolic blood pressure | baseline and 12 weeks |
| changes of diastolic blood pressure | changes of diastolic blood pressure | baseline and 12 weeks |
| changes of gut microbiota | changes of gut microbiota by metagenomics | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| gut microbiota | changes of gut microbiota by metagenomics | baseline 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Xia, PhD | Contact | +86 20 87332433 | xiamin@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Min Xia, PhD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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placebo-controlled, randomized clinical trial
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) 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 and taste to highland barley β-glucan supplement |
|
| baseline and 12 weeks |
| ankle Brachial Index | changes of ankle Brachial Index by VP-1000plus from Omron | baseline and 12 weeks |
| microbial metabolite | changes of microbial metabolite by untargeted metabolomics | baseline and 12 weeks |
| central aortic pressure | changes of central aortic pressure by VICORDER Complete Vascular Laboratory | baseline and 12 weeks |
| flow-mediated dilation | changes of flow-mediated dilation by VICORDER Complete Vascular Laboratory | baseline and 12 weeks |
| carotid-femoral pulse wave velocity | changes of carotid-femoral pulse wave velocity by VICORDER Complete Vascular Laboratory | baseline and 12 weeks |