Clinical trial NCT06559982: Effects of a Brown Seaweed Tart Cherry Blend in Mild-moderate Hypertension
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Systolic blood pressure
timeFrame: Baseline
measure: Systolic blood pressure
timeFrame: 20 days
Secondary outcomes:
measure: Diastolic blood pressure
timeFrame: Baseline
measure: Diastolic blood pressure
timeFrame: 20 days
measure: Percent bodyfat and fat mass
timeFrame: Baseline
measure: Percent bodyfat and fat mass
timeFrame: 20 days
measure: Waist circumference
timeFrame: Baseline
measure: Waist circumference
timeFrame: 20 days
measure: Waist to hip ratio
timeFrame: Baseline
measure: Waist to hip ratio
timeFrame: 20 days
measure: Blood glucose
timeFrame: Baseline
measure: Blood glucose
timeFrame: 20 days
measure: Blood triglycerides
timeFrame: Baseline
measure: Blood triglycerides
timeFrame: 20 days
measure: Blood cholesterol (Total, HDL & LDL)
timeFrame: Baseline
measure: Blood cholesterol (Total, HDL & LDL)
timeFrame: 20 days
measure: Total and HDL cholesterol ratio
timeFrame: Baseline
measure: Total and HDL cholesterol ratio
timeFrame: 20 days
measure: LDL and HDL cholesterol ratio
timeFrame: Baseline
measure: LDL and HDL cholesterol ratio
timeFrame: 20 days
measure: Triglyceride glucose index
timeFrame: Baseline
measure: Triglyceride glucose index
timeFrame: 20 days
measure: Coop-Wonka chart
timeFrame: Baseline
measure: Coop-Wonka chart
timeFrame: 20 days
measure: Beck Depression Inventory
timeFrame: Baseline
measure: Beck Depression Inventory
timeFrame: 20 days
measure: State Trait Anxiety Inventory
timeFrame: Baseline
measure: State Trait Anxiety Inventory
timeFrame: 20 days
measure: Insomnia Severity Index
timeFrame: Baseline
measure: Insomnia Severity Index
timeFrame: 20 days
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index
timeFrame: 20 days
measure: Epworth Sleepiness Scale
timeFrame: Baseline
measure: Epworth Sleepiness Scale
timeFrame: 20 days
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: University of Central Lancashire
state: Lancashire
Study officials:
References: