Effect of Prebiotics on Blood Pressure Management

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05364736
• Other study ID #: 2020HBßG-H
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: December 31, 2030

Study information

• Verified date: May 2022
• Source: Sun Yat-sen University
• Contact: Min Xia, PhD
• Phone: +86 20 87332433
• Email: xiamin[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gastrointestinal Microbiome
• Hypertension

Intervention

Dietary Supplement:
• Highland barley ß-glucan dietary supplement
100 mL oral liquid mainly containing highland barley ß-glucan once daily for 12 weeks

Other:
• Placebo controls
Placebo with a similar appearance and taste to highland barley ß-glucan supplement

Locations

Country	Name	City	State
China	Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of systolic blood pressure	changes of systolic blood pressure	baseline and 12 weeks
Primary	changes of diastolic blood pressure	changes of diastolic blood pressure	baseline and 12 weeks
Primary	changes of gut microbiota	changes of gut microbiota by metagenomics	baseline and 12 weeks
Secondary	gut microbiota	changes of gut microbiota by metagenomics	baseline and 12 weeks
Secondary	pulse wave velocity	changes of pulse wave velocity by VP-1000plus from Omron	baseline and 12 weeks
Secondary	ankle Brachial Index	changes of ankle Brachial Index by VP-1000plus from Omron	baseline and 12 weeks
Secondary	microbial metabolite	changes of microbial metabolite by untargeted metabolomics	baseline and 12 weeks
Secondary	central aortic pressure	changes of central aortic pressure by VICORDER Complete Vascular Laboratory	baseline and 12 weeks
Secondary	flow-mediated dilation	changes of flow-mediated dilation by VICORDER Complete Vascular Laboratory	baseline and 12 weeks
Secondary	carotid-femoral pulse wave velocity	changes of carotid-femoral pulse wave velocity by VICORDER Complete Vascular Laboratory	baseline and 12 weeks