Gastrointestinal Microbiome, Hypertension
Conditions
Keywords
Hypertension, Gastrointestinal Microbiome, Prebiotics
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTHighland barley β-glucan dietary supplement
100 mL oral liquid mainly containing highland barley β-glucan once daily for 12 weeks
OTHERPlacebo controls
Placebo with a similar appearance and taste to highland barley β-glucan supplement
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
placebo-controlled, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age:30-65 years old 2. 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. 3. BMI≥18 kg/m2
Exclusion criteria
1. Receiving or have been treated with antihypertensive drugs. 2. Complications including cardiovascular and cerebrovascular diseases such as coronary heart disease and stroke. 3. 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). 4. Autoimmune diseases or thyroid diseases. 5. Women who are pregnant, nursing, or prepare to give birth during the trail. 6. Malignant disease, infectious disease, inflammatory disease and advanced liver disease. 7. Mental or intellectual abnormalities, unable to sign informed consent. 8. Complications including chronic gastrointestinal disease; or suffered from acute gastrointestinal diseases within 1 months before screening visit. 9. Received antibiotics, probiotics within 3 months before screening visit or throughout the trail. 10. Major operations were performed within six months of screening visit, or will be made during the trial. 11. Alcohol abuse (alcohol intake\>60g/d for male and alcohol intake\>40g/d for female)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes of systolic blood pressure | baseline and 12 weeks | changes of systolic blood pressure |
| changes of diastolic blood pressure | baseline and 12 weeks | changes of diastolic blood pressure |
| changes of gut microbiota | baseline and 12 weeks | changes of gut microbiota by metagenomics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| microbial metabolite | baseline and 12 weeks | changes of microbial metabolite by untargeted metabolomics |
| central aortic pressure | baseline and 12 weeks | changes of central aortic pressure by VICORDER Complete Vascular Laboratory |
| gut microbiota | baseline and 12 weeks | changes of gut microbiota by metagenomics |
| carotid-femoral pulse wave velocity | baseline and 12 weeks | changes of carotid-femoral pulse wave velocity by VICORDER Complete Vascular Laboratory |
| flow-mediated dilation | baseline and 12 weeks | changes of flow-mediated dilation by VICORDER Complete Vascular Laboratory |
| pulse wave velocity | baseline and 12 weeks | changes of pulse wave velocity by VP-1000plus from Omron |
| ankle Brachial Index | baseline and 12 weeks | changes of ankle Brachial Index by VP-1000plus from Omron |
Countries
China
Contacts
Primary ContactMin Xia, PhD
Outcome results
None listed