ClinicalTrials.Veeva

Menu

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

U

University of Central Lancashire

Status

Begins enrollment in 7 months

Conditions

Hypertension

Treatments

Other: Placebo
Dietary Supplement: Brown seaweed and tart cherry blend

Study type

Interventional

Funder types

Other

Identifiers

NCT06559982
Seaweed-cherry hypertension

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Identical in taste and colour to the supplement juice, but with no peppermint content.
Treatment:
Other: Placebo
Brown seaweed and tart cherry blend
Experimental group
Treatment:
Dietary Supplement: Brown seaweed and tart cherry blend

Trial contacts and locations

1

Loading...

Central trial contact

Jonathan Sinclair, PhD, DSc

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems