Thinking of joining a study?

Register your interest

NCT06559982 | NOT YET RECRUITING | Hypertension


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

University of Central Lancashire

Information provided by (Responsible Party):

Jonathan Sinclair

Brief Summary:

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.

Condition or disease

Hypertension

Intervention/treatment

Brown seaweed and tart cherry blend

Placebo

Phase

NA

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2026-05-01
Estimated Study Completion Date : 2026-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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
Exclusion Criteria
  • * 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

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

Location Details

NCT06559982


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United Kingdom, Lancashire

University of Central Lancashire

Preston, Lancashire, United Kingdom, PR4 0PE

Loading...