Effects of a Brown Seaweed Tart Cherry Blend in Mild-moderate Hypertension

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Brown seaweed and tart cherry blend
  Blend of brown seaweed and tart cherry blend taken twice daily
• Другое Placebo
  Identical in taste and colour to the supplement, but with no brown seaweed or tart cherry.

Первичные конечные точки

• Systolic blood pressure [Срок оценки: Baseline]
• Systolic blood pressure [Срок оценки: 20 days]

Вторичные конечные точки (12)

• Diastolic blood pressure [Срок оценки: Baseline]
• Diastolic blood pressure [Срок оценки: 20 days]
• Percent bodyfat and fat mass [Срок оценки: Baseline]
• Percent bodyfat and fat mass [Срок оценки: 20 days]
• Waist circumference [Срок оценки: Baseline]
• Waist circumference [Срок оценки: 20 days]
• Waist to hip ratio [Срок оценки: Baseline]
• Waist to hip ratio [Срок оценки: 20 days]
• Blood glucose [Срок оценки: Baseline]
• Blood glucose [Срок оценки: 20 days]
• Blood triglycerides [Срок оценки: Baseline]
• Blood triglycerides [Срок оценки: 20 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• University of Central Lancashire — Preston

Идентификаторы

NCT: NCT06559982 · Seaweed-cherry hypertension

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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