Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:07 AM
Study NCT ID:
NCT07474233
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Associations Between Dietary Patterns, LDL Aggregation, and Cardiometabolic Health: A Cross-sectional Analysis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, serum, plasma and urine will be collected and retained for analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Qualitative interview', 'timeFrame': 'Baseline upon enrollment.', 'description': 'Participants will complete a semi-structured interview (\\~30-45 minutes) to explore their experiences of their chosen dietary pattern. Interviews will assess eating behaviour, attitudes, motivation, and perceived impact of the chosen diet. Question subsections include overall experience, practical challenges, social and lifestyle factors, and intentions to continue the diet. Interviews will be conducted in person or online via Microsoft Teams, audio-recorded with consent, transcribed verbatim, and anonymised prior to thematic analysis.'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline upon enrollment.', 'description': 'Change in resting systolic and diastolic blood pressure. Blood pressure reflects cardiovascular function and may be influenced by dietary fat type and nutrient composition.'}, {'measure': 'Flow-mediated dilation (FMD)', 'timeFrame': 'Baseline upon enrollment.', 'description': 'Change in blood vessel function will be assessed using a non-invasive ultrasound test to measure how well the arteries widen (dilate) in response to increased blood flow.'}, {'measure': 'Plasma glucose', 'timeFrame': 'Baseline upon enrollment.', 'description': 'Changes in fasting blood glucose will be assessed via biochemical plasma analysis of a venous blood sample and recorded in mmol/L.'}, {'measure': 'Dietary adherence', 'timeFrame': 'Baseline prior to enrollment.', 'description': "Participants' self-reported adherence to the assigned diet will be collected through completion of a 3-day online food log/diary via a mobile phone application."}, {'measure': 'Pulse wave velocity (PWV)', 'timeFrame': 'Baseline upon enrollment.', 'description': 'Non-invasive ultrasound measurement of how quickly blood pressure waves move through the carotid artery.'}, {'measure': 'Carotid intima media thickness (CIMT)', 'timeFrame': 'Baseline upon enrollment.', 'description': 'CIMT is a non-invasive ultrasound method used to measure the thickness of an artery wall which can give information about blood vessel health.'}, {'measure': 'Height', 'timeFrame': 'Baseline upon enrollment.', 'description': 'Height will be measured in metres using a stadiometer.'}, {'measure': 'Body weight', 'timeFrame': 'Baseline upon enrollment.', 'description': 'Changes in body weight will be measured in kilograms using a SECA bioelectrical impedance analyser.'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'Baseline upon enrollment.', 'description': "BMI will be calculated calculated by dividing an adult's weight in kilograms by their height in meters squared."}, {'measure': 'Body fat percentage', 'timeFrame': 'Baseline upon enrollment.', 'description': 'Using a SECA bioelectrical impedance analyser, body fat percentage will be estimated by sending a weak, painless electrical current through the body, measuring the resistance (impedance) encountered.'}, {'measure': 'Waist to hip ratio', 'timeFrame': 'Baseline upon enrollment.', 'description': 'Waist to hip ratio will be measured using a measuring tape to measure the narrowest point of the waist and the widest point of the hips. The ratio will be calculated by dividing waist circumference by hip circumference (WHR = Waist ÷ Hip) using the same unit of measurement (cm or inches).'}, {'measure': 'Plasma insulin', 'timeFrame': 'Baseline upon enrollment.', 'description': 'Changes in fasting blood insulin levels will be assessed via biochemical plasma analysis of a venous blood sample and recorded in mcU/mL.'}, {'measure': 'Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)', 'timeFrame': 'Baseline upon enrollment.', 'description': 'HOMA-IR measures insulin resistance using fasting blood glucose and insulin, with a score of \\> 2.0 or 2.5 typically indicating resistance.'}, {'measure': 'International Physical Activity Questionnaire (IPAQ)', 'timeFrame': 'Baseline upon enrollment.', 'description': 'A validated self-report questionnaire assessing physical activity performed during the previous 7 days. Participants report frequency and duration of vigorous activity, moderate activity, walking, and sedentary time. Responses are used to estimate total habitual physical activity (e.g., MET-minutes/week).'}, {'measure': 'Need for Cognition Scale (NCS)', 'timeFrame': 'Baseline upon enrollment.', 'description': "An 18-item self-report scale measuring an individual's tendency to engage in and enjoy effortful cognitive activity. Items are rated on a Likert-type scale (1-5; strongly disagree to strongly agree). Scores are summed or averaged, with higher scores indicating greater need for cognition."}, {'measure': 'Generic Conspiracist Beliefs Scale (GCBS)', 'timeFrame': 'Baseline upon enrollment.', 'description': 'A 15-item self-report questionnaire assessing general endorsement of conspiracy beliefs across multiple domains. Items are rated on a 5-point Likert scale (1 = definitely not true to 5 = definitely true). Higher scores indicate stronger conspiracist beliefs.'}, {'measure': 'Media and Technology Usage and Attitudes Scale (MTUAS)', 'timeFrame': 'Baseline upon enrollment.', 'description': 'A self-report measure assessing frequency of digital media and technology use and attitudes toward technology. Items assessing usage are rated on Likert-type frequency scales (e.g., 1 = never to 10 = all the time), while attitude items use agreement Likert scales. Higher scores reflect greater usage or stronger attitudes toward technology.'}, {'measure': 'Belief in Science Scale (BISS)', 'timeFrame': 'Baseline upon enrollment.', 'description': 'A self-report questionnaire measuring the extent to which individuals view science as a reliable and authoritative source of knowledge. Items are rated on a 6-point Likert scale (strongly disagree to strongly agree), with higher scores indicating stronger belief in science.'}, {'measure': 'Scientific Determinism Scale (SDS)', 'timeFrame': 'Baseline upon enrollment.', 'description': 'A self-report scale assessing beliefs that human behaviour and events are determined by scientific and physical laws. Items are rated on a Likert-type agreement scale (e.g., 1 = strongly disagree to 7 = strongly agree), with higher scores indicating stronger endorsement of scientific determinism.'}, {'measure': 'Social Identification Scale (SIS)', 'timeFrame': 'Baseline upon enrollment.', 'description': 'A self-report measure assessing the degree to which individuals identify with a specific social group. Items are rated on a Likert-type agreement scale (typically 1-7), measuring aspects such as group belonging, attachment, and identification. Higher scores indicate stronger social identification.'}], 'primaryOutcomes': [{'measure': 'LDL aggregation susceptibility', 'timeFrame': 'Baseline upon enrollment.', 'description': "To measure changes in how easily LDL cholesterol particles 'clump' together in the blood vessels from baseline to post-intervention, assessed via plasma lipid and lipoprotein analysis."}], 'secondaryOutcomes': [{'measure': 'Plasma lipid and lipoprotein profile', 'timeFrame': 'Baseline upon enrollment.', 'description': 'Changes in plasma levels of total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides will be determined via enzymatic analysis and measured in mmol/L.'}, {'measure': 'Lipoprotein particle size', 'timeFrame': 'Baseline upon enrollment.', 'description': 'Changes in lipoprotein particle size (diameter) will be measured via Nuclear Magnetic Resonance spectroscopy (NMR) and expressed in nanometers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LDL aggregation', 'Dietary patterns', 'Atherosclerosis', 'Cardiovascular disease', 'Onmivore diet', 'Vegan diet', 'Carnivore diet', 'Lipid profile', 'Cardiometabolic health'], 'conditions': ['Atherosclerosis Cardiovascular Disease', 'Metabolic Syndrome', 'Dyslipidaemia', 'Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the extent to which vegan or plant-based, omnivorous, and carnivore dietary patterns affect LDL aggregation susceptibility (the affinity for LDL cholesterol particles to clump together in the blood), which may promote plaque build-up in arteries. Using a cross-sectional mixed-methods design, the study will measure LDL aggregation, blood lipids, and other metabolic biomarkers in individuals following these diets, and combine these data with dietary and behavioural information to examine links with cardiovascular and metabolic health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals based in or around the Liverpool and North West area that habitually follow one of the three pre-specified dietary patterns.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 25-60 years.\n* BMI range (18.5-29.9 kg/m²).\n* Following one of the specified dietary patterns (vegan/plant-based, carnivore, or omnivorous) for a minimum of 6 months.\n* Self-identified as health-focused (i.e., intentionally following the diet for perceived health benefits).\n\nExclusion Criteria:\n\n* BMI outside the stated range (\\<18.5 or ≥30 kg/m²).\n* Use of lipid-lowering medications or supplements that may interfere with LDL levels.\n* Pregnancy or breastfeeding.\n* Any significant deviation from the specified diet within the last month.'}, 'identificationModule': {'nctId': 'NCT07474233', 'briefTitle': 'Associations Between Dietary Patterns, LDL Aggregation, and Cardiometabolic Health: A Cross-sectional Analysis.', 'organization': {'class': 'OTHER', 'fullName': 'Liverpool John Moores University'}, 'officialTitle': 'Associations Between Dietary Pattern Adherence, LDL Aggregation, and Cardiometabolic Health: A Cross-sectional Analysis.', 'orgStudyIdInfo': {'id': '260106LJMUREC269'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vegan or plant-based diet', 'description': 'Individuals who identify as adhering to a vegan or plant-based diet habitually for a minimum period of six months.'}, {'label': 'Carnivore diet', 'description': 'Individuals who identify as adhering to a carnivore diet composed exclusively of animal-based products habitually for a minimum period of six months.'}, {'label': 'Omnivore diet', 'description': 'Individuals who identify as adhering to an omnivorous (animal and plant-based) diet habitually for a minimum period of six months.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L3 3AF', 'city': 'Liverpool', 'state': 'ENG', 'country': 'United Kingdom', 'contacts': [{'name': 'Megan L Wilson', 'role': 'CONTACT', 'email': 'M.L.Wilson@ljmu.ac.uk', 'phone': '07362317430'}, {'name': 'Dr Richie Kirwan', 'role': 'CONTACT', 'email': 'R.P.Kirwan@ljmu.ac.uk'}], 'facility': 'Tom Reilly Building, Liverpool John Moores University', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'centralContacts': [{'name': 'Megan L Wilson, BSc Nutrition', 'role': 'CONTACT', 'email': 'M.L.Wilson@ljmu.ac.uk', 'phone': '+447362317430'}, {'name': 'Dr Richie Kirwan', 'role': 'CONTACT', 'email': 'R.P.Kirwan@ljmu.ac.uk'}], 'overallOfficials': [{'name': 'Richie Kirwan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Liverpool John Moores University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liverpool John Moores University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Megan Wilson', 'investigatorAffiliation': 'Liverpool John Moores University'}}}}