Effect of Prebiotics on Blood Pressure Management

Официальное название

An Interventional Study for the Effects of Highland Barley β-glucan on the Management of Hypertension and Cardiovascular Risk

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Highland barley β-glucan dietary supplement
  100 mL oral liquid mainly containing highland barley β-glucan once daily for 12 weeks
• Другое Placebo controls
  Placebo with a similar appearance and taste to highland barley β-glucan supplement

Первичные конечные точки

• changes of systolic blood pressure [Срок оценки: baseline and 12 weeks]
• changes of diastolic blood pressure [Срок оценки: baseline and 12 weeks]
• changes of gut microbiota [Срок оценки: baseline and 12 weeks]

Вторичные конечные точки (7)

• gut microbiota [Срок оценки: baseline and 12 weeks]
• pulse wave velocity [Срок оценки: baseline and 12 weeks]
• ankle Brachial Index [Срок оценки: baseline and 12 weeks]
• microbial metabolite [Срок оценки: baseline and 12 weeks]
• central aortic pressure [Срок оценки: baseline and 12 weeks]
• flow-mediated dilation [Срок оценки: baseline and 12 weeks]
• carotid-femoral pulse wave velocity [Срок оценки: baseline and 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT05364736 · 2020HBβG-H

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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