Status:
NOT_YET_RECRUITING
Effect of Prebiotics on Blood Pressure Management
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hypertension
Gastrointestinal Microbiome
Eligibility:
All Genders
30-65 years
Phase:
NA
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 hypert...
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 unc...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05364736
Start Date
October 17 2022
End Date
December 31 2030
Last Update
May 6 2022
Active Locations (1)
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1
Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080