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NCT Number: NCT06559982

Effects of a Brown Seaweed Tart Cherry Blend in Mild-moderate Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Lancashire

Preston, Lancashire, PR4 0PE, United Kingdom

Location contact

Jonathan Sinclair, DSc, PhD

CONTACT

[email protected]

07875651533

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brown seaweed and tart cherry blend

Dietary Supplement

Blend of brown seaweed and tart cherry blend taken twice daily

Placebo

Other

Identical in taste and colour to the supplement, but with no brown seaweed or tart cherry.

Primary outcomes

  1. Systolic blood pressure

    Time frame: Baseline

    Systolic blood pressure - measured using a digital blood pressure monitor

  2. Systolic blood pressure

    Time frame: 20 days

    Systolic blood pressure - measured using a digital blood pressure monitor

Secondary outcomes

  1. Diastolic blood pressure

    Time frame: Baseline

    Diastolic blood pressure - measured using a digital blood pressure monitor

  2. Diastolic blood pressure

    Time frame: 20 days

    Diastolic blood pressure - measured using a digital blood pressure monitor

  3. Percent bodyfat and fat mass

    Time frame: Baseline

    Participants percentage composition of fat - measured using bio-electrical impedance

  4. Percent bodyfat and fat mass

    Time frame: 20 days

    Participants percentage composition of fat - measured using bio-electrical impedance

  5. Waist circumference

    Time frame: Baseline

    Waist circumference - measured using anthropocentric tape

  6. Waist circumference

    Time frame: 20 days

    Waist circumference - measured using anthropocentric tape

  7. Waist to hip ratio

    Time frame: Baseline

    Ratio of waist to hip circumference - measured using anthropocentric tape

  8. Waist to hip ratio

    Time frame: 20 days

    Ratio of waist to hip circumference - measured using anthropocentric tape

  9. Blood glucose

    Time frame: Baseline

    Capillary blood glucose - mmol/L

  10. Blood glucose

    Time frame: 20 days

    Capillary blood glucose - mmol/L

  11. Blood triglycerides

    Time frame: Baseline

    Capillary blood triglycerides - mmol/L

  12. Blood triglycerides

    Time frame: 20 days

    Capillary blood triglycerides - mmol/L

  13. Blood cholesterol (Total, HDL & LDL)

    Time frame: Baseline

    Capillary blood cholesterol - mmol/L

  14. Blood cholesterol (Total, HDL & LDL)

    Time frame: 20 days

    Capillary blood cholesterol - mmol/L

  15. Total and HDL cholesterol ratio

    Time frame: Baseline

    Ratio of total cholesterol to HDL cholesterol

  16. Total and HDL cholesterol ratio

    Time frame: 20 days

    Ratio of total cholesterol to HDL cholesterol

  17. LDL and HDL cholesterol ratio

    Time frame: Baseline

    Ratio of LDL to HDL cholesterol

  18. LDL and HDL cholesterol ratio

    Time frame: 20 days

    Ratio of LDL to HDL cholesterol

  19. Triglyceride glucose index

    Time frame: Baseline

    Log transformed measurement of the blood glucose and blood triglyceride measures

  20. Triglyceride glucose index

    Time frame: 20 days

    Log transformed measurement of the blood glucose and blood triglyceride measures

  21. Coop-Wonka chart

    Time frame: Baseline

    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.

  22. Coop-Wonka chart

    Time frame: 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.

  23. Beck Depression Inventory

    Time frame: Baseline

    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.

  24. Beck Depression Inventory

    Time frame: 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.

  25. State Trait Anxiety Inventory

    Time frame: Baseline

    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.

  26. State Trait Anxiety Inventory

    Time frame: 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.

  27. Insomnia Severity Index

    Time frame: Baseline

    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.

  28. Insomnia Severity Index

    Time frame: 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.

  29. Pittsburgh Sleep Quality Index

    Time frame: Baseline

    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.

  30. Pittsburgh Sleep Quality Index

    Time frame: 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.

  31. Epworth Sleepiness Scale

    Time frame: Baseline

    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.

  32. Epworth Sleepiness Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Sinclair, PhD, DSc

CONTACT

[email protected]

07875651533

Sponsors and collaborators

Lead sponsor

University of Central Lancashire

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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