Clinical trial NCT05364736: Effect of Prebiotics on Blood Pressure Management
Official title: An Interventional Study for the Effects of Highland Barley β-glucan on the Management of Hypertension and Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Gastrointestinal Microbiome
Keywords: Hypertension
Gastrointestinal Microbiome
Prebiotics
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo-controlled, randomized clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: changes of systolic blood pressure
timeFrame: baseline and 12 weeks
measure: changes of diastolic blood pressure
timeFrame: baseline and 12 weeks
measure: changes of gut microbiota
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: gut microbiota
timeFrame: baseline and 12 weeks
measure: pulse wave velocity
timeFrame: baseline and 12 weeks
measure: ankle Brachial Index
timeFrame: baseline and 12 weeks
measure: microbial metabolite
timeFrame: baseline and 12 weeks
measure: central aortic pressure
timeFrame: baseline and 12 weeks
measure: flow-mediated dilation
timeFrame: baseline and 12 weeks
measure: carotid-femoral pulse wave velocity
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Min Xia, PhD
role: PRINCIPAL_INVESTIGATOR
References: