Back to resultsEffect of Prebiotics on Blood Pressure Management
Primary Purpose
Hypertension, Gastrointestinal Microbiome
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Highland barley β-glucan dietary supplement
Placebo controls
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension focused on measuring Hypertension, Gastrointestinal Microbiome, Prebiotics
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)
Sites / Locations
- Sun Yat-Sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Highland barley β-glucan group
Placebo group
Arm Description
Participants will be given oral liquids mainly containing highland barley β-glucan once daily for 12 weeks followed by comprehensive physical and clinical examinations.
Participants will be given oral liquids mainly containing Corn starch once daily for 12 weeks followed by comprehensive physical and clinical examinations.
Outcomes
Primary Outcome Measures
changes of systolic blood pressure
changes of systolic blood pressure
changes of diastolic blood pressure
changes of diastolic blood pressure
changes of gut microbiota
changes of gut microbiota by metagenomics
Secondary Outcome Measures
gut microbiota
changes of gut microbiota by metagenomics
pulse wave velocity
changes of pulse wave velocity by VP-1000plus from Omron
ankle Brachial Index
changes of ankle Brachial Index by VP-1000plus from Omron
microbial metabolite
changes of microbial metabolite by untargeted metabolomics
central aortic pressure
changes of central aortic pressure by VICORDER Complete Vascular Laboratory
flow-mediated dilation
changes of flow-mediated dilation by VICORDER Complete Vascular Laboratory
carotid-femoral pulse wave velocity
changes of carotid-femoral pulse wave velocity by VICORDER Complete Vascular Laboratory
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05364736
Brief Title
Effect of Prebiotics on Blood Pressure Management
Official Title
An Interventional Study for the Effects of Highland Barley β-glucan on the Management of Hypertension and Cardiovascular Risk
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 17, 2022 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Gastrointestinal Microbiome
Keywords
Hypertension, Gastrointestinal Microbiome, Prebiotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
placebo-controlled, randomized clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Highland barley β-glucan group
Arm Type
Experimental
Arm Description
Participants will be given oral liquids mainly containing highland barley β-glucan once daily for 12 weeks followed by comprehensive physical and clinical examinations.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Participants will be given oral liquids mainly containing Corn starch once daily for 12 weeks followed by comprehensive physical and clinical examinations.
Intervention Type
Dietary Supplement
Intervention Name(s)
Highland barley β-glucan dietary supplement
Intervention Description
100 mL oral liquid mainly containing highland barley β-glucan once daily for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo controls
Intervention Description
Placebo with a similar appearance and taste to highland barley β-glucan supplement
Primary Outcome Measure Information:
Title
changes of systolic blood pressure
Description
changes of systolic blood pressure
Time Frame
baseline and 12 weeks
Title
changes of diastolic blood pressure
Description
changes of diastolic blood pressure
Time Frame
baseline and 12 weeks
Title
changes of gut microbiota
Description
changes of gut microbiota by metagenomics
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
gut microbiota
Description
changes of gut microbiota by metagenomics
Time Frame
baseline and 12 weeks
Title
pulse wave velocity
Description
changes of pulse wave velocity by VP-1000plus from Omron
Time Frame
baseline and 12 weeks
Title
ankle Brachial Index
Description
changes of ankle Brachial Index by VP-1000plus from Omron
Time Frame
baseline and 12 weeks
Title
microbial metabolite
Description
changes of microbial metabolite by untargeted metabolomics
Time Frame
baseline and 12 weeks
Title
central aortic pressure
Description
changes of central aortic pressure by VICORDER Complete Vascular Laboratory
Time Frame
baseline and 12 weeks
Title
flow-mediated dilation
Description
changes of flow-mediated dilation by VICORDER Complete Vascular Laboratory
Time Frame
baseline and 12 weeks
Title
carotid-femoral pulse wave velocity
Description
changes of carotid-femoral pulse wave velocity by VICORDER Complete Vascular Laboratory
Time Frame
baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Xia, PhD
Phone
+86 20 87332433
Email
xiamin@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Xia, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Xia, PhD
Phone
+86-2087332433
Email
xiamin@mail.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Prebiotics on Blood Pressure Management
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