Effect of Prebiotics on Blood Pressure Management

NCT05364736 | Not Yet Recruiting DMC

• 1 other identifier: 2020HBβG-H
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Gastrointestinal Microbiome

Keywords

Hypertension; Gastrointestinal Microbiome; Prebiotics

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• gut microbiota

  baseline and 12 weeks

• pulse wave velocity

  baseline and 12 weeks

• ankle Brachial Index

  baseline and 12 weeks

• microbial metabolite

  baseline and 12 weeks

• central aortic pressure

  baseline and 12 weeks

Study Arms (2)

Highland barley β-glucan group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Highland barley β-glucan dietary supplement DIETARY_SUPPLEMENT

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

Highland barley β-glucan group

Placebo controls OTHER

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

Placebo group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Min Xia, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Xia, PhD

CONTACT

+86 20 87332433; xiamin@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Participants, investigators and care providers at the scene are all blinded to the allocation of treatment group. Data collected will be analyzed by another investigator who is blinded to the study design.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: placebo-controlled, randomized clinical trial

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 6, 2022
• Study Start: October 17, 2022
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)