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临床试验/NCT06559982
NCT06559982尚未招募不适用

Effects of a Brown Seaweed Extract and Tart Cherry Blend Cardiometabolic Outcomes in Participants With Mild-moderate Hypertension an Ex-vivo Optimized Pilot Feasibility Trial

University of Central Lancashire2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
2
主要终点
Systolic blood pressure

研究概览

简要总结

The brown seaweed species Ascophyllum nodosum is rich in bioactive polysaccharides, proteins, peptides, lipids, pigments, and polyphenols. Similarly, Montmorency tart cherry (Prunus cerasus L.) is high in anthocyanins and polyphenols. Both substances have antioxidant, anti-inflammatory, and vasodilatory properties that target mechanisms central to hypertension and cardiometabolic diseases.

Dietary interventions to improve cardiovascular health are highly sought after as they possess less risk and financial burden than pharmacological drugs. Previous randomized trial has shown that both brown seaweed and tart cherry supplementation can improving systolic blood pressure and other cardiovascular/ blood lipids. However, to date, no research has explored a seaweed - tart cherry blend using a placebo randomized intervention in patients with hypertension.

The primary purpose of the proposed investigation is to test the ability of a seaweed - tart cherry supplementation blend to improve cardiometabolic parameters in participants with mild-moderate hypertension using a pilot/ feasibility study.

详细描述

Hypertension is the leading preventable risk factor for cardiovascular disease and mortality, causing over 75,000 annual UK deaths. It affects 31% of males and 26% of females, with about 30% having uncontrolled blood pressure. The UK has 14.4 million hypertensive individuals due to aging, population growth, and lifestyle factors. Hypertension accounts for 12% of GP appointments and £2.1 billion in annual healthcare costs, making it the most expensive disease modality.

Effective management can significantly reduce stroke and heart disease risk. A 2mmHg reduction in systolic blood pressure decreases coronary heart disease mortality by 7% and stroke risk by 10%. A 5mmHg reduction over 10 years could save the NHS nearly £1 billion. This highlights the need for alternative approaches due to pharmaceutical treatments' high cost and side effects.

The brown seaweed species Ascophyllum nodosum is rich in bioactive polysaccharides, proteins, peptides, lipids, pigments, and polyphenols. Similarly, Montmorency tart cherry (Prunus cerasus L.) is high in anthocyanins and polyphenols. Both substances have antioxidant, anti-inflammatory, and vasodilatory properties that target mechanisms central to hypertension and cardiometabolic diseases. Prior to the commencement of this pilot/ feasibility trial, we will evaluate the efficacy of a brown seaweed-tart cherry blend using an ex-vivo model to determine the optimal proportions of each and to understand the molecular effects. The most bioactive blend will be tested in this trial.

The primary purpose of the proposed investigation is to test the ability of a seaweed - tart cherry supplementation blend to improve cardiometabolic parameters in participants with mild-moderate hypertension using a pilot/ feasibility study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged from 18-65 years
  • Systolic blood pressure 120 to 139 mmHg
  • Not taking prescribed medicine for blood pressure management
  • Ability to complete written questionnaires independently
  • Able to provide informed consent

排除标准

  • Diagnosed with diabetes mellitus and/ or coronary heart disease
  • Pregnant and lactating women
  • Allergy to peppermint
  • Habitual consumption of peppermint products
  • Regular consumption of antioxidant supplements
  • Body mass index larger than 40.0 kg/m2
  • Current enrolment in other clinical trials of other external therapies

结局指标

主要结局

Systolic blood pressure

时间窗: 20 days

Systolic blood pressure - measured using a digital blood pressure monitor

次要结局

  • Percent bodyfat and fat mass(20 days)
  • Beck Depression Inventory(20 days)
  • Insomnia Severity Index(20 days)
  • Pittsburgh Sleep Quality Index(20 days)
  • Waist circumference(20 days)
  • Blood cholesterol (Total, HDL & LDL)(20 days)
  • Blood glucose(20 days)
  • Diastolic blood pressure(20 days)
  • Blood triglycerides(20 days)
  • LDL and HDL cholesterol ratio(20 days)
  • Epworth Sleepiness Scale(20 days)
  • Triglyceride glucose index(20 days)
  • Waist to hip ratio(20 days)
  • State Trait Anxiety Inventory(20 days)
  • Total and HDL cholesterol ratio(20 days)
  • Coop-Wonka chart(20 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Sinclair

Professor

University of Central Lancashire

研究点 (2)

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