Effects of a Brown Seaweed Tart Cherry Blend in Mild-moderate Hypertension
NCT Number: NCT06559982
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension
Interventions: DIETARY_SUPPLEMENT: Brown seaweed and tart cherry blend|OTHER: Placebo
Sponsor: University of Central Lancashire
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2025-05-01
Completion Date: 2026-07-01
Locations: University of Central Lancashire, Preston, Lancashire, PR4 0PE, United Kingdom

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.

Primary Outcome Measures: 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: 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|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|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|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