Effect of Prebiotics on Blood Pressure Management

Not Applicable

Not yet recruiting

• Conditions: Gastrointestinal Microbiome; Hypertension
• Interventions: Other: Placebo controls; Dietary Supplement: Highland barley β-glucan dietary supplement

• Registration Number: NCT05364736
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-03
• Last Update Submitted: 2022-05-03
• Study First Posted: 2022-05-06
• Last Update Posted: 2022-05-06
• Study Start: 2022-10-17
• Primary Completion: 2023-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo controls	Participants will be given oral liquids mainly containing Corn starch once daily for 12 weeks followed by comprehensive physical and clinical examinations.
Highland barley β-glucan group	Highland barley β-glucan dietary supplement	Participants will be given oral liquids mainly containing highland barley β-glucan once daily for 12 weeks followed by comprehensive physical and clinical examinations.

Primary Outcome Measures

Name	Time	Method
changes of gut microbiota	baseline and 12 weeks	changes of gut microbiota by metagenomics
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

Secondary Outcome Measures

Name	Time	Method
microbial metabolite	baseline and 12 weeks	changes of microbial metabolite by untargeted metabolomics
flow-mediated dilation	baseline and 12 weeks	changes of flow-mediated dilation by VICORDER Complete Vascular Laboratory
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
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

Trial Locations

Locations (1)

Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China