Effect of Prebiotics on Blood Pressure Management

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Gastrointestinal Microbiome
• Intervention / Treatment: Other: Placebo controls; Dietary supplement: Highland barley β-glucan dietary supplement

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Xia, PhD; Phone Number: +86 20 87332433; Email: xiamin@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Sun Yat-sen University
      • Contact: Min Xia, PhD; Phone Number: +86-2087332433; Email: xiamin@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Highland barley β-glucan group; 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; 100 mL oral liquid mainly containing highland barley β-glucan once daily for 12 weeks
Placebo Comparator: Placebo group; 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; Placebo with a similar appearance and taste to highland barley β-glucan supplement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Min Xia, PhD, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 17, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Hypertension; Gastrointestinal Microbiome; Prebiotics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2020HBβG-H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No