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NCT Number: NCT05364736

Effect of Prebiotics on Blood Pressure Management

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Highland barley β-glucan dietary supplement

Dietary Supplement

100 mL oral liquid mainly containing highland barley β-glucan once daily for 12 weeks

Placebo controls

Other

Placebo with a similar appearance and taste to highland barley β-glucan supplement

Primary outcomes

  1. changes of systolic blood pressure

    Time frame: baseline and 12 weeks

    changes of systolic blood pressure

  2. changes of diastolic blood pressure

    Time frame: baseline and 12 weeks

    changes of diastolic blood pressure

  3. changes of gut microbiota

    Time frame: baseline and 12 weeks

    changes of gut microbiota by metagenomics

Secondary outcomes

  1. gut microbiota

    Time frame: baseline and 12 weeks

    changes of gut microbiota by metagenomics

  2. pulse wave velocity

    Time frame: baseline and 12 weeks

    changes of pulse wave velocity by VP-1000plus from Omron

  3. ankle Brachial Index

    Time frame: baseline and 12 weeks

    changes of ankle Brachial Index by VP-1000plus from Omron

  4. microbial metabolite

    Time frame: baseline and 12 weeks

    changes of microbial metabolite by untargeted metabolomics

  5. central aortic pressure

    Time frame: baseline and 12 weeks

    changes of central aortic pressure by VICORDER Complete Vascular Laboratory

  6. flow-mediated dilation

    Time frame: baseline and 12 weeks

    changes of flow-mediated dilation by VICORDER Complete Vascular Laboratory

  7. carotid-femoral pulse wave velocity

    Time frame: baseline and 12 weeks

    changes of carotid-femoral pulse wave velocity by VICORDER Complete Vascular Laboratory

Study contacts

Contact information is provided by the study sponsor or research team.

Min Xia, PhD

CONTACT

[email protected]

+86 20 87332433

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2030
First posted
May 6, 2022
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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