Viewing Study NCT06559982



Ignite Creation Date: 2024-10-26 @ 3:38 PM
Last Modification Date: 2024-10-26 @ 3:38 PM
Study NCT ID: NCT06559982
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-15

Brief Title: Effects of a Brown Seaweed Tart Cherry Blend in Mild-moderate Hypertension
Sponsor: None
Organization: None

Study Overview

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
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 75000 annual UK deaths It affects 31 of males and 26 of females with about 30 having uncontrolled blood pressure The UK has 144 million hypertensive individuals due to aging population growth and lifestyle factors Hypertension accounts for 12 of GP appointments and 21 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None