Effects of a Brown Seaweed Tart Cherry Blend in Mild-moderate Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brown seaweed and tart cherry blend, Placebo.
- Who it may be relevant to
- Registry conditions: Hypertension. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Dietary supplement Brown seaweed and tart cherry blend
Blend of brown seaweed and tart cherry blend taken twice daily - Other Placebo
Identical in taste and colour to the supplement, but with no brown seaweed or tart cherry.
Primary outcome measures
- Systolic blood pressure [Time frame: Baseline]
- Systolic blood pressure [Time frame: 20 days]
Secondary outcome measures (12)
- Diastolic blood pressure [Time frame: Baseline]
- Diastolic blood pressure [Time frame: 20 days]
- Percent bodyfat and fat mass [Time frame: Baseline]
- Percent bodyfat and fat mass [Time frame: 20 days]
- Waist circumference [Time frame: Baseline]
- Waist circumference [Time frame: 20 days]
- Waist to hip ratio [Time frame: Baseline]
- Waist to hip ratio [Time frame: 20 days]
- Blood glucose [Time frame: Baseline]
- Blood glucose [Time frame: 20 days]
- Blood triglycerides [Time frame: Baseline]
- Blood triglycerides [Time frame: 20 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- University of Central Lancashire — Preston
Identifiers
NCT: NCT06559982 · Seaweed-cherry hypertension