Effects of a Brown Seaweed Tart Cherry Blend in Mild-moderate Hypertension
- Conditions
- Hypertension
- Interventions
- Other: PlaceboDietary Supplement: Brown seaweed and tart cherry blend
- Registration Number
- NCT06559982
- Lead Sponsor
- University of Central Lancashire
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Identical in taste and colour to the supplement juice, but with no peppermint content. Brown seaweed and tart cherry blend Brown seaweed and tart cherry blend -
- Primary Outcome Measures
Name Time Method Systolic blood pressure 20 days Systolic blood pressure - measured using a digital blood pressure monitor
- Secondary Outcome Measures
Name Time Method Insomnia Severity Index 20 days 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.
Beck Depression Inventory 20 days 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.
Pittsburgh Sleep Quality Index 20 days 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.
Blood cholesterol (Total, HDL & LDL) 20 days Capillary blood cholesterol - mmol/L
Diastolic blood pressure 20 days Diastolic blood pressure - measured using a digital blood pressure monitor
Percent bodyfat and fat mass 20 days Participants percentage composition of fat - measured using bio-electrical impedance
Waist circumference 20 days Waist circumference - measured using anthropocentric tape
Blood glucose 20 days Capillary blood glucose - mmol/L
Blood triglycerides 20 days Capillary blood triglycerides - mmol/L
LDL and HDL cholesterol ratio 20 days Ratio of LDL to HDL cholesterol
Epworth Sleepiness Scale 20 days 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.
Waist to hip ratio 20 days Ratio of waist to hip circumference - measured using anthropocentric tape
Coop-Wonka chart 20 days 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.
Triglyceride glucose index 20 days Log transformed measurement of the blood glucose and blood triglyceride measures
State Trait Anxiety Inventory 20 days 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.
Total and HDL cholesterol ratio 20 days Ratio of total cholesterol to HDL cholesterol
Trial Locations
- Locations (1)
University of Central Lancashire
🇬🇧Preston, Lancashire, United Kingdom