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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Placebo
Identical in taste and colour to the supplement juice, but with no peppermint content.
干预措施: Placebo (Other)
Brown seaweed and tart cherry blend
干预措施: Brown seaweed and tart cherry blend (Dietary Supplement)
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
Systolic blood pressure
时间窗: Baseline
Systolic blood pressure - measured using a digital blood pressure monitor
次要结局
- Blood cholesterol (Total, HDL & LDL)(20 days)
- Blood triglycerides(20 days)
- Beck Depression Inventory(20 days)
- Insomnia Severity Index(20 days)
- Pittsburgh Sleep Quality Index(20 days)
- Diastolic blood pressure(20 days)
- Percent bodyfat and fat mass(20 days)
- Waist circumference(20 days)
- Blood glucose(20 days)
- LDL and HDL cholesterol ratio(20 days)
- Waist to hip ratio(20 days)
- Triglyceride glucose index(20 days)
- State Trait Anxiety Inventory(20 days)
- Total and HDL cholesterol ratio(20 days)
- Coop-Wonka chart(20 days)
- Epworth Sleepiness Scale(20 days)
- Waist circumference(Baseline)
- Diastolic blood pressure(Baseline)
- Percent bodyfat and fat mass(Baseline)
- Waist to hip ratio(Baseline)
- Blood glucose(Baseline)
- Blood triglycerides(Baseline)
- Blood cholesterol (Total, HDL & LDL)(Baseline)
- Total and HDL cholesterol ratio(Baseline)
- LDL and HDL cholesterol ratio(Baseline)
- Triglyceride glucose index(Baseline)
- Coop-Wonka chart(Baseline)
- Beck Depression Inventory(Baseline)
- State Trait Anxiety Inventory(Baseline)
- Insomnia Severity Index(Baseline)
- Pittsburgh Sleep Quality Index(Baseline)
- Epworth Sleepiness Scale(Baseline)
研究者
Jonathan Sinclair
Professor
University of Central Lancashire