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Not yet recruiting NCT05364736

Effect of Prebiotics on Blood Pressure Management

No phase Interventional Hypertension Gastrointestinal Microbiome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Highland barley β-glucan dietary supplement, Placebo controls.
Who it may be relevant to
Registry conditions: Hypertension, Gastrointestinal Microbiome. Basic parameters: 30 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Dietary supplement Highland barley β-glucan dietary supplement
    100 mL oral liquid mainly containing highland barley β-glucan once daily for 12 weeks
  • Other Placebo controls
    Placebo with a similar appearance and taste to highland barley β-glucan supplement

Primary outcome measures

  • changes of systolic blood pressure [Time frame: baseline and 12 weeks]
  • changes of diastolic blood pressure [Time frame: baseline and 12 weeks]
  • changes of gut microbiota [Time frame: baseline and 12 weeks]
Secondary outcome measures (7)
  • gut microbiota [Time frame: baseline and 12 weeks]
  • pulse wave velocity [Time frame: baseline and 12 weeks]
  • ankle Brachial Index [Time frame: baseline and 12 weeks]
  • microbial metabolite [Time frame: baseline and 12 weeks]
  • central aortic pressure [Time frame: baseline and 12 weeks]
  • flow-mediated dilation [Time frame: baseline and 12 weeks]
  • carotid-femoral pulse wave velocity [Time frame: baseline and 12 weeks]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Sun Yat-Sen University — Guangzhou

Identifiers

NCT: NCT05364736 · 2020HBβG-H

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗