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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Blend of brown seaweed and tart cherry blend taken twice daily
Identical in taste and colour to the supplement, but with no brown seaweed or tart cherry.
University of Central Lancashire
Preston, Lancashire, United Kingdom
Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor
Time frame: Baseline
Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor
Time frame: 20 days
Diastolic blood pressure
Diastolic blood pressure - measured using a digital blood pressure monitor
Time frame: Baseline
Diastolic blood pressure
Diastolic blood pressure - measured using a digital blood pressure monitor
Time frame: 20 days
Percent bodyfat and fat mass
Participants percentage composition of fat - measured using bio-electrical impedance
Time frame: Baseline
Percent bodyfat and fat mass
Participants percentage composition of fat - measured using bio-electrical impedance
Time frame: 20 days
Waist circumference
Waist circumference - measured using anthropocentric tape
Time frame: Baseline
Waist circumference
Waist circumference - measured using anthropocentric tape
Time frame: 20 days
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Time frame: Baseline
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Time frame: 20 days
Blood glucose
Capillary blood glucose - mmol/L
Time frame: Baseline
Blood glucose
Capillary blood glucose - mmol/L
Time frame: 20 days
Blood triglycerides
Capillary blood triglycerides - mmol/L
Time frame: Baseline
Blood triglycerides
Capillary blood triglycerides - mmol/L
Time frame: 20 days
Blood cholesterol (Total, HDL & LDL)
Capillary blood cholesterol - mmol/L
Time frame: Baseline
Blood cholesterol (Total, HDL & LDL)
Capillary blood cholesterol - mmol/L
Time frame: 20 days
Total and HDL cholesterol ratio
Ratio of total cholesterol to HDL cholesterol
Time frame: Baseline
Total and HDL cholesterol ratio
Ratio of total cholesterol to HDL cholesterol
Time frame: 20 days
LDL and HDL cholesterol ratio
Ratio of LDL to HDL cholesterol
Time frame: Baseline
LDL and HDL cholesterol ratio
Ratio of LDL to HDL cholesterol
Time frame: 20 days
Triglyceride glucose index
Log transformed measurement of the blood glucose and blood triglyceride measures
Time frame: Baseline
Triglyceride glucose index
Log transformed measurement of the blood glucose and blood triglyceride measures
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 20 days
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