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

NCT ID: NCT06559982

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-07-01

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.

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Identical in taste and colour to the supplement juice, but with no peppermint content.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Identical in taste and colour to the supplement, but with no brown seaweed or tart cherry.

Brown seaweed and tart cherry blend

Group Type: EXPERIMENTAL

Brown seaweed and tart cherry blend

Intervention Type: DIETARY_SUPPLEMENT

Blend of brown seaweed and tart cherry blend taken twice daily

Interventions

Brown seaweed and tart cherry blend

Blend of brown seaweed and tart cherry blend taken twice daily

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Identical in taste and colour to the supplement, but with no brown seaweed or tart cherry.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Central Lancashire

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Sinclair

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Central Lancashire

Preston, Lancashire, United Kingdom

Countries

United Kingdom

Central Contacts

Jonathan Sinclair, PhD, DSc

Role: CONTACT

jksinclair@uclan.ac.uk

07875651533

Facility Contacts

Jonathan Sinclair, DSc, PhD

Role: primary

jksinclair@uclan.ac.uk

07875651533

Other Identifiers

Seaweed-cherry hypertension

Identifier Type: -

Identifier Source: org_study_id