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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: Placebo; Dietary supplement: Brown seaweed and tart cherry blend

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
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Sinclair, PhD, DSc; Phone Number: 07875651533; Email: jksinclair@uclan.ac.uk

Study Locations

• United Kingdom
  • Lancashire
    • Preston, Lancashire, United Kingdom, PR4 0PE
      • University of Central Lancashire
      • Contact: Jonathan Sinclair, DSc, PhD; Phone Number: 07875651533; Email: jksinclair@uclan.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Identical in taste and colour to the supplement juice, but with no peppermint content.	Other: Placebo; Identical in taste and colour to the supplement, but with no brown seaweed or tart cherry.
Experimental: Brown seaweed and tart cherry blend	Dietary supplement: Brown seaweed and tart cherry blend; Blend of brown seaweed and tart cherry blend taken twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	Systolic blood pressure - measured using a digital blood pressure monitor	Baseline
Systolic blood pressure	Systolic blood pressure - measured using a digital blood pressure monitor	20 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	Waist circumference - measured using anthropocentric tape	Baseline
Waist circumference	Waist circumference - measured using anthropocentric tape	20 days
Waist to hip ratio	Ratio of waist to hip circumference - measured using anthropocentric tape	Baseline
Waist to hip ratio	Ratio of waist to hip circumference - measured using anthropocentric tape	20 days
Blood glucose	Capillary blood glucose - mmol/L	Baseline
Blood glucose	Capillary blood glucose - mmol/L	20 days
Blood triglycerides	Capillary blood triglycerides - mmol/L	Baseline
Blood triglycerides	Capillary blood triglycerides - mmol/L	20 days
Blood cholesterol (Total, HDL & LDL)	Capillary blood cholesterol - mmol/L	Baseline
Blood cholesterol (Total, HDL & LDL)	Capillary blood cholesterol - mmol/L	20 days
Coop-Wonka chart	Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.	Baseline
Coop-Wonka chart	Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.	20 days
Beck Depression Inventory	Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.	Baseline
Beck Depression Inventory	Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.	20 days
State Trait Anxiety Inventory	Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.	Baseline
State Trait Anxiety Inventory	Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.	20 days
Insomnia Severity Index	Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.	Baseline
Insomnia Severity Index	Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.	20 days
Pittsburgh Sleep Quality Index	Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.	Baseline
Pittsburgh Sleep Quality Index	Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.	20 days
Epworth Sleepiness Scale	Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.	Baseline
Epworth Sleepiness Scale	Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.	20 days
Diastolic blood pressure	Diastolic blood pressure - measured using a digital blood pressure monitor	Baseline
Diastolic blood pressure	Diastolic blood pressure - measured using a digital blood pressure monitor	20 days
Percent bodyfat and fat mass	Participants percentage composition of fat - measured using bio-electrical impedance	Baseline
Percent bodyfat and fat mass	Participants percentage composition of fat - measured using bio-electrical impedance	20 days
Total and HDL cholesterol ratio	Ratio of total cholesterol to HDL cholesterol	Baseline
Total and HDL cholesterol ratio	Ratio of total cholesterol to HDL cholesterol	20 days
LDL and HDL cholesterol ratio	Ratio of LDL to HDL cholesterol	Baseline
LDL and HDL cholesterol ratio	Ratio of LDL to HDL cholesterol	20 days
Triglyceride glucose index	Log transformed measurement of the blood glucose and blood triglyceride measures	Baseline
Triglyceride glucose index	Log transformed measurement of the blood glucose and blood triglyceride measures	20 days

Collaborators and Investigators

• Sponsor: University of Central Lancashire

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 18, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: Seaweed-cherry hypertension

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No