HypertensionNCT05364736
Effect of Prebiotics on Blood Pressure Management
A study testing Highland barley β-glucan dietary supplement in people with Hypertension and Gastrointestinal Microbiome, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Gastrointestinal Microbiome
- What is being tested?
- Highland barley β-glucan dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2022to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Min Xia, PhD, +86-2087332433, xiamin@mail.sysu.edu.cn
About this study
Official title: An Interventional Study for the Effects of Highland Barley β-glucan on the Management of Hypertension and Cardiovascular Risk
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.
Read the 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.
- Conditions
- Hypertension, Gastrointestinal Microbiome
- Being tested
- Highland barley β-glucan dietary supplement, Placebo controls
- Keywords
- Hypertension, Gastrointestinal Microbiome, Prebiotics
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highland barley β-glucan dietary supplementDietary supplement
100 mL oral liquid mainly containing highland barley β-glucan once daily for 12 weeks
Placebo controlsOther
Placebo with a similar appearance and taste to highland barley β-glucan supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of systolic blood pressure
changes of systolic blood pressure
Measured: baseline and 12 weeks
changes of diastolic blood pressure
changes of diastolic blood pressure
Measured: baseline and 12 weeks
changes of gut microbiota
changes of gut microbiota by metagenomics
Measured: baseline and 12 weeks
Secondary outcomes (7)
gut microbiota
changes of gut microbiota by metagenomics
Measured: baseline and 12 weeks
pulse wave velocity
changes of pulse wave velocity by VP-1000plus from Omron
Measured: baseline and 12 weeks
ankle Brachial Index
changes of ankle Brachial Index by VP-1000plus from Omron
Measured: baseline and 12 weeks
microbial metabolite
changes of microbial metabolite by untargeted metabolomics
Measured: baseline and 12 weeks
central aortic pressure
changes of central aortic pressure by VICORDER Complete Vascular Laboratory
Measured: baseline and 12 weeks
flow-mediated dilation
changes of flow-mediated dilation by VICORDER Complete Vascular Laboratory
Measured: baseline and 12 weeks
carotid-femoral pulse wave velocity
changes of carotid-femoral pulse wave velocity by VICORDER Complete Vascular Laboratory
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start17 Oct 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo-controlled, randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Xia, Sun Yat-sen University
- Investigators
- Min Xia, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364736
- Sponsor's protocol ID
- 2020HBβG-H
- Status last verified
- May 2022
- First submitted
- 3 May 2022
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study for the Effects of Highland Barley β-glucan on the Management of Hypertension and Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT05364736
- Acronym / sponsor ID
- 2020HBβG-H
- Conditions
- Hypertension, Gastrointestinal Microbiome
- Keywords
- Hypertension, Gastrointestinal Microbiome, Prebiotics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 17 Oct 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- placebo-controlled, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Highland barley β-glucan group | Experimental | Dietary Supplement: Highland barley β-glucan dietary supplementParticipants will be given oral liquids mainly containing highland barley β-glucan once daily for 12 weeks followed by comprehensive physical and clinical examinations. |
| Placebo group | Placebo comparator | Other: Placebo controlsParticipants will be given oral liquids mainly containing Corn starch once daily for 12 weeks followed by comprehensive physical and clinical examinations. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Highland barley β-glucan dietary supplement100 mL oral liquid mainly containing highland barley β-glucan once daily for 12 weeks | Dietary supplement | Highland barley β-glucan group |
| Placebo controlsPlacebo with a similar appearance and taste to highland barley β-glucan supplement | Other | Placebo group |
Primary outcome
changes of systolic blood pressure
Time frame: baseline and 12 weeks
changes of systolic blood pressure
changes of diastolic blood pressure
Time frame: baseline and 12 weeks
changes of diastolic blood pressure
changes of gut microbiota
Time frame: baseline and 12 weeks
changes of gut microbiota by metagenomics
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Min Xia, PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Highland barley β-glucan dietary supplement in people with Hypertension and Gastrointestinal Microbiome, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Xia, PhD (+86 20 87332433, xiamin@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of systolic blood pressure (time frame: baseline and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.