Effect of Prebiotics on Blood Pressure Management
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Highland barley β-glucan dietary supplement
Dietary supplement100 mL oral liquid mainly containing highland barley β-glucan once daily for 12 weeks
Placebo controls
Other interventionPlacebo with a similar appearance and taste to highland barley β-glucan supplement
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Highland barley β-glucan groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
changes of systolic blood pressure
changes of systolic blood pressure
Time frame
baseline and 12 weeks2
changes of diastolic blood pressure
changes of diastolic blood pressure
Time frame
baseline and 12 weeks3
changes of gut microbiota
changes of gut microbiota by metagenomics
Time frame
baseline and 12 weeksSecondary outcomes
1
gut microbiota
changes of gut microbiota by metagenomics
Time frame
baseline and 12 weeks2
pulse wave velocity
changes of pulse wave velocity by VP-1000plus from Omron
Time frame
baseline and 12 weeks3
ankle Brachial Index
changes of ankle Brachial Index by VP-1000plus from Omron
Time frame
baseline and 12 weeks4
microbial metabolite
changes of microbial metabolite by untargeted metabolomics
Time frame
baseline and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: