HypertensionNCT06559982
Effects of a Brown Seaweed Tart Cherry Blend in Mild-moderate Hypertension
A study testing Brown seaweed and tart cherry blend in people with Hypertension, run by University of Central Lancashire at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Brown seaweed and tart cherry blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Central Lancashire
Preston, Lancashire, PR4 0PE
Jonathan Sinclair, DSc, PhD, 07875651533, jksinclair@uclan.ac.uk
About this study
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
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Brown seaweed and tart cherry blend, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brown seaweed and tart cherry blendDietary supplement
Blend of brown seaweed and tart cherry blend taken twice daily
PlaceboOther
Identical in taste and colour to the supplement, but with no brown seaweed or tart cherry.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Identical in taste and colour to the supplement juice, but with no peppermint content. Receives: Other: Placebo |
| Brown seaweed and tart cherry blend | Experimental | Not described Receives: Dietary Supplement: Brown seaweed and tart cherry blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor
Measured: Baseline
Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor
Measured: 20 days
Secondary outcomes (32)
Diastolic blood pressure
Diastolic blood pressure - measured using a digital blood pressure monitor
Measured: Baseline
Diastolic blood pressure
Diastolic blood pressure - measured using a digital blood pressure monitor
Measured: 20 days
Percent bodyfat and fat mass
Participants percentage composition of fat - measured using bio-electrical impedance
Measured: Baseline
Percent bodyfat and fat mass
Participants percentage composition of fat - measured using bio-electrical impedance
Measured: 20 days
Waist circumference
Waist circumference - measured using anthropocentric tape
Measured: Baseline
Waist circumference
Waist circumference - measured using anthropocentric tape
Measured: 20 days
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Measured: Baseline
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Measured: 20 days
Blood glucose
Capillary blood glucose - mmol/L
Measured: Baseline
Blood glucose
Capillary blood glucose - mmol/L
Measured: 20 days
Blood triglycerides
Capillary blood triglycerides - mmol/L
Measured: Baseline
Blood triglycerides
Capillary blood triglycerides - mmol/L
Measured: 20 days
Blood cholesterol (Total, HDL & LDL)
Capillary blood cholesterol - mmol/L
Measured: Baseline
Blood cholesterol (Total, HDL & LDL)
Capillary blood cholesterol - mmol/L
Measured: 20 days
Total and HDL cholesterol ratio
Ratio of total cholesterol to HDL cholesterol
Measured: Baseline
Total and HDL cholesterol ratio
Ratio of total cholesterol to HDL cholesterol
Measured: 20 days
LDL and HDL cholesterol ratio
Ratio of LDL to HDL cholesterol
Measured: Baseline
LDL and HDL cholesterol ratio
Ratio of LDL to HDL cholesterol
Measured: 20 days
Triglyceride glucose index
Log transformed measurement of the blood glucose and blood triglyceride measures
Measured: Baseline
Triglyceride glucose index
Log transformed measurement of the blood glucose and blood triglyceride measures
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Sinclair, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559982
- Sponsor's protocol ID
- Seaweed-cherry hypertension
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06559982
- Acronym / sponsor ID
- Seaweed-cherry hypertension
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboIdentical in taste and colour to the supplement juice, but with no peppermint content. |
| Brown seaweed and tart cherry blend | Experimental | Dietary Supplement: Brown seaweed and tart cherry blend |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brown seaweed and tart cherry blendBlend of brown seaweed and tart cherry blend taken twice daily | Dietary supplement | Brown seaweed and tart cherry blend |
| PlaceboIdentical in taste and colour to the supplement, but with no brown seaweed or tart cherry. | Other | Placebo |
Primary outcome
Systolic blood pressure
Time frame: Baseline
Systolic blood pressure - measured using a digital blood pressure monitor
Systolic blood pressure
Time frame: 20 days
Systolic blood pressure - measured using a digital blood pressure monitor
32 secondary outcomes
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
Blood cholesterol (Total, HDL & LDL)
Time frame: Baseline
Blood cholesterol (Total, HDL & LDL)
Time frame: 20 days
Total and HDL cholesterol ratio
Time frame: Baseline
Total and HDL cholesterol ratio
Time frame: 20 days
LDL and HDL cholesterol ratio
Time frame: Baseline
LDL and HDL cholesterol ratio
Time frame: 20 days
Triglyceride glucose index
Time frame: Baseline
Triglyceride glucose index
Time frame: 20 days
Coop-Wonka chart
Time frame: Baseline
Coop-Wonka chart
Time frame: 20 days
Beck Depression Inventory
Time frame: Baseline
Beck Depression Inventory
Time frame: 20 days
State Trait Anxiety Inventory
Time frame: Baseline
State Trait Anxiety Inventory
Time frame: 20 days
Insomnia Severity Index
Time frame: Baseline
Insomnia Severity Index
Time frame: 20 days
Pittsburgh Sleep Quality Index
Time frame: Baseline
Pittsburgh Sleep Quality Index
Time frame: 20 days
Epworth Sleepiness Scale
Time frame: Baseline
Epworth Sleepiness Scale
Time frame: 20 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brown seaweed and tart cherry blend in people with Hypertension, run by University of Central Lancashire at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Sinclair, PhD, DSc (07875651533, jksinclair@uclan.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.