[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559119":3},{"organization":4,"outcomesModule":7,"designInfo":81,"detailedDescription":90,"studyPopulation":80,"armGroups":91,"interventions":103,"overallOfficials":80,"centralContacts":111,"locations":117,"responsibleParty":133,"collaborators":80,"id":137,"slug":80,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":80,"eligibilityCriteria":142,"healthyVolunteers":138,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":80,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":80,"overallStatus":155,"whyStopped":80,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"University of Central Lancashire","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":80},[9,13],{"measure":10,"description":11,"timeFrame":12},"Systolic blood pressure","Systolic blood pressure - measured using a digital blood pressure monitor","Baseline",{"measure":10,"description":11,"timeFrame":14},"20 days",[16,19,20,23,24,27,28,31,32,35,36,39,40,43,44,47,48,51,52,55,56,59,60,63,64,67,68,71,72,75,76,79],{"measure":17,"description":18,"timeFrame":12},"Diastolic blood pressure","Diastolic blood pressure - measured using a digital blood pressure monitor",{"measure":17,"description":18,"timeFrame":14},{"measure":21,"description":22,"timeFrame":12},"Percent bodyfat and fat mass","Participants percentage composition of fat - measured using bio-electrical impedance",{"measure":21,"description":22,"timeFrame":14},{"measure":25,"description":26,"timeFrame":12},"Waist circumference","Waist circumference - measured using anthropocentric tape",{"measure":25,"description":26,"timeFrame":14},{"measure":29,"description":30,"timeFrame":12},"Waist to hip ratio","Ratio of waist to hip circumference - measured using anthropocentric tape",{"measure":29,"description":30,"timeFrame":14},{"measure":33,"description":34,"timeFrame":12},"Blood glucose","Capillary blood glucose - mmol\u002FL",{"measure":33,"description":34,"timeFrame":14},{"measure":37,"description":38,"timeFrame":12},"Blood triglycerides","Capillary blood triglycerides - mmol\u002FL",{"measure":37,"description":38,"timeFrame":14},{"measure":41,"description":42,"timeFrame":12},"Blood cholesterol (Total, HDL & LDL)","Capillary blood cholesterol - mmol\u002FL",{"measure":41,"description":42,"timeFrame":14},{"measure":45,"description":46,"timeFrame":12},"Total and HDL cholesterol ratio","Ratio of total cholesterol to HDL cholesterol",{"measure":45,"description":46,"timeFrame":14},{"measure":49,"description":50,"timeFrame":12},"LDL and HDL cholesterol ratio","Ratio of LDL to HDL cholesterol",{"measure":49,"description":50,"timeFrame":14},{"measure":53,"description":54,"timeFrame":12},"Triglyceride glucose index","Log transformed measurement of the blood glucose and blood triglyceride measures",{"measure":53,"description":54,"timeFrame":14},{"measure":57,"description":58,"timeFrame":12},"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.",{"measure":57,"description":58,"timeFrame":14},{"measure":61,"description":62,"timeFrame":12},"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.",{"measure":61,"description":62,"timeFrame":14},{"measure":65,"description":66,"timeFrame":12},"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.",{"measure":65,"description":66,"timeFrame":14},{"measure":69,"description":70,"timeFrame":12},"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.",{"measure":69,"description":70,"timeFrame":14},{"measure":73,"description":74,"timeFrame":12},"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.",{"measure":73,"description":74,"timeFrame":14},{"measure":77,"description":78,"timeFrame":12},"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.",{"measure":77,"description":78,"timeFrame":14},null,{"allocation":82,"interventionModel":83,"interventionModelDescription":80,"primaryPurpose":84,"observationalModel":80,"timePerspective":80,"maskingInfo":85},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":86,"maskingDescription":80,"whoMasked":87},"DOUBLE",[88,89],"PARTICIPANT","INVESTIGATOR","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.\n\nEffective 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.\n\nThe 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\u002F 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.\n\nThe 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\u002F feasibility study.",[92,98],{"label":93,"type":94,"description":95,"interventionNames":96},"Placebo","PLACEBO_COMPARATOR","Identical in taste and colour to the supplement juice, but with no peppermint content.",[97],"Other: Placebo",{"label":99,"type":100,"description":80,"interventionNames":101},"Brown seaweed and tart cherry blend","EXPERIMENTAL",[102],"Dietary Supplement: Brown seaweed and tart cherry blend",[104,108],{"type":105,"name":99,"description":106,"armGroupLabels":107,"otherNames":80},"DIETARY_SUPPLEMENT","Blend of brown seaweed and tart cherry blend taken twice daily",[99],{"type":6,"name":93,"description":109,"armGroupLabels":110,"otherNames":80},"Identical in taste and colour to the supplement, but with no brown seaweed or tart cherry.",[93],[112],{"name":113,"role":114,"phone":115,"phoneExt":80,"email":116},"Jonathan Sinclair, PhD, DSc","CONTACT","07875651533","jksinclair@uclan.ac.uk",[118],{"facility":5,"status":80,"city":119,"state":120,"zip":121,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":129,"contacts":130},"Preston","Lancashire","PR4 0PE","United Kingdom","UK",{"type":125,"coordinates":126},"Point",[127,128],-2.70452,53.76282,{"lat":128,"lon":127},[131],{"name":132,"role":114,"phone":115,"phoneExt":80,"email":116},"Jonathan Sinclair, DSc, PhD",{"type":134,"investigatorFullName":135,"investigatorTitle":136,"investigatorAffiliation":5,"oldNameTitle":80,"oldOrganization":80},"PRINCIPAL_INVESTIGATOR","Jonathan Sinclair","Professor","100559119",false,"NCT06559982","Effects of a Brown Seaweed Tart Cherry Blend in Mild-moderate Hypertension","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","Inclusion Criteria:\n\n* Aged from 18-65 years\n* Systolic blood pressure 120 to 139 mmHg\n* Not taking prescribed medicine for blood pressure management\n* Ability to complete written questionnaires independently\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Diagnosed with diabetes mellitus and\u002F or coronary heart disease\n* Pregnant and lactating women\n* Allergy to peppermint\n* Habitual consumption of peppermint products\n* Regular consumption of antioxidant supplements\n* Body mass index larger than 40.0 kg\u002Fm2\n* Current enrolment in other clinical trials of other external therapies","ALL","18 Years","65 Years",{"count":147,"type":148},30,"ESTIMATED","INTERVENTIONAL",[151],"NA","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.\n\nDietary 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\u002F blood lipids. However, to date, no research has explored a seaweed - tart cherry blend using a placebo randomized intervention in patients with hypertension.\n\nThe 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\u002F feasibility study.",[154],"Hypertension","NOT_YET_RECRUITING","2024-08-18",{"date":158,"type":159},"2024-08-20","ACTUAL",{"date":161,"type":148},"2025-05-01",{"date":163,"type":148},"2026-07-01",{"name":5,"class":6},1]