Highland barley β-glucan dietary supplement: 100 mL oral liquid mainly containing highland barley β-glucan once daily for 12 weeks
Placebo controls: Placebo with a similar appearance and taste to highland barley β-glucan supplement
Study 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.
Eligibility
Sex
ALL
Min age
30 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Age:30-65 years old
2. 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.
3. BMI≥18 kg/m2
Exclusion Criteria:
1. Receiving or have been treated with antihypertensive drugs.
2. Complications including cardiovascular and cerebrovascular diseases such as coronary heart disease and stroke.
3. 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).
4. Autoimmune diseases or thyroid diseases.
5. Women who are pregnant, nursing, or prepare to give birth during the trail.
6. Malignant disease, infectious disease, inflammatory disease and advanced liver disease.
7. Mental or intellectual abnormalities, unable to sign informed consent.
8. Complications including chronic gastrointestinal disease; or suffered from acute gastrointestinal diseases within 1 months before screening visit.
9. Received antibiotics, probiotics within 3 months before screening visit or throughout the trail.
10. Major operations were performed within six months of screening visit, or will be made during the trial.
11. Alcohol abuse (alcohol intake\>60g/d for male and alcohol intake\>40g/d for female)
Primary outcome measure(s)
changes of systolic blood pressure — baseline and 12 weeks changes of systolic blood pressure
changes of diastolic blood pressure — baseline and 12 weeks changes of diastolic blood pressure
changes of gut microbiota — baseline and 12 weeks changes of gut microbiota by metagenomics
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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