Effect of Prebiotics on Blood Pressure Management

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Interventional Study for the Effects of Highland Barley β-glucan on the Management of Hypertension and Cardiovascular Risk

Conditions
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Hypertension, Gastrointestinal Microbiome

Intervention / Treatment
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* Dietary Supplement: Highland barley β-glucan dietary supplement
* Other: Placebo controls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:30-65 years old Newly diagnosed hypertension did not use antihypertensive drugs OR Systolic blood pressure ≥140mmHg on the physical examination OR Diastolic blood pressure ≥90mmHg on the physical examination. BMI≥18 kg/m2 Exclusion Criteria: Receiving or have been treated with antihypertensive drugs. Complications including cardiovascular and cerebrovascular diseases such as coronary heart disease and stroke. Severe liver or renal insufficiency (alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase is greater than 3 times the upper limit of normal OR GFR<30ml/min/1.73m2). Autoimmune diseases or thyroid diseases. Women who are pregnant, nursing, or prepare to give birth during the trail. Malignant disease, infectious disease, inflammatory disease and advanced liver disease. Mental or intellectual abnormalities, unable to sign informed consent. Complications including chronic gastrointestinal disease; or suffered from acute gastrointestinal diseases within 1 months before screening visit. Received antibiotics, probiotics within 3 months before screening visit or throughout the trail. Major operations were performed within six months of screening visit, or will be made during the trial. Alcohol abuse (alcohol intake>60g/d for male and alcohol intake>40g/d for female)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: placebo-controlled, randomized clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Highland barley β-glucan group<br>Participants will be given oral liquids mainly containing highland barley β-glucan once daily for 12 weeks followed by comprehensive physical and clinical examinations. | Dietary Supplement: Highland barley β-glucan dietary supplement<br>* 100 mL oral liquid mainly containing highland barley β-glucan once daily for 12 weeks<br>|
| Placebo Comparator: Placebo group<br>Participants will be given oral liquids mainly containing Corn starch once daily for 12 weeks followed by comprehensive physical and clinical examinations. | Other: Placebo controls<br>* Placebo with a similar appearance and taste to highland barley β-glucan supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Gastrointestinal Microbiome, Prebiotics