Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT01478958
Status:
COMPLETED
Last Update Posted:
2014-07-15
First Post:
2011-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dietary Intervention and Vascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'j.a.lovegrove@reading.ac.uk', 'phone': '+44 (0)118 3786418', 'title': 'Professor Julie Lovegrove', 'organization': 'University of Reading'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'High Saturated Fat Diet', 'description': 'SFA diet: Volunteers followed a high saturated fat diet for a 4-month period', 'otherNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Monounsaturated Fat Diet', 'description': 'MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period', 'otherNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High n-6 Polyunsaturated Fat Diet', 'description': 'n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period', 'otherNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Flow Mediated Dilatation (FMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Saturated Fat Diet', 'description': 'SFA diet: Volunteers followed a high saturated fat diet for a 4-month period'}, {'id': 'OG001', 'title': 'High Monounsaturated Fat Diet', 'description': 'MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period'}, {'id': 'OG002', 'title': 'High n-6 Polyunsaturated Fat Diet', 'description': 'n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.39', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.31', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.238', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Overall diet effect. No post-hoc analyses required. Adjusted for multiple comparisons.', 'groupDescription': 'To detect a 2% inter-group difference in FMD (primary outcome) using a SD of 2.3, 90% power and 5% significance level, n=171 participants were required (n=57 per group), increasing to n=228 to include a 25% dropout rate.', 'statisticalMethod': 'General Linear Model Univariate Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline values for %FMD, BMI, age, gender and intervention diet used as prognostic factors in model.', 'testedNonInferiority': False}, {'pValue': '0.021', 'groupIds': ['OG000'], 'pValueComment': 'Effect of the SFA-rich diet relative to baseline.', 'statisticalMethod': 'General Linear Model Univariate Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.', 'testedNonInferiority': False}, {'pValue': '>0.05', 'groupIds': ['OG001'], 'pValueComment': 'Effect of MUFA-rich diet relative to baseline.', 'statisticalMethod': 'General Linear Model Univariate Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.', 'testedNonInferiority': False}, {'pValue': '>0.05', 'groupIds': ['OG002'], 'pValueComment': 'Effect of n-6 PUFA-rich diet relative to baseline.', 'statisticalMethod': 'General Linear Model Univariate Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 months', 'unitOfMeasure': 'post-occlusion diameter change as %', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed: n=171. n=24 were images of poor quality that could not be analyzed successfully.'}, {'type': 'SECONDARY', 'title': 'Cardiovascular Risk Factors (Lipids, Inflammatory Markers, Indices of Insulin Resistance, Cell Microparticles, Endothelial Progenitor Cells)', 'timeFrame': '4 months', 'description': 'Data for fasting serum lipids (total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), TC:HDL-C ratio, low-density lipoprotein cholesterol (LDL-C), triacylglycerol (TAG)).', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': '24-hour Ambulatory Blood Pressure', 'timeFrame': '4 months', 'description': '24-hour, daytime and night-time measures of systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP; SBP-DBP) and heart rate (HR)', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Vascular Stiffness by Pulse Wave Velocity (PWV), Pulse Wave Analysis (PWA) and Digital Volume Pulse (DVP)', 'timeFrame': '4 months', 'description': 'PWV (m/s) PWA produces Augmentation Index (AIx; %) DVP produces Stiffness Index (SI; m/s) and Reflection Index (RI; %)', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis)', 'timeFrame': '4 months', 'description': 'Laser Doppler imaging (LDI) with iontophoresis of acetylcholine (Ach; endothelium-dependent vasodilation) and sodium nitroprusside (SNP; endothelium-independent vasodilation).', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Saturated Fat Diet', 'description': 'SFA diet: Volunteers followed a high saturated fat diet for a 4-month period'}, {'id': 'FG001', 'title': 'High Monounsaturated Fat Diet', 'description': 'MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period'}, {'id': 'FG002', 'title': 'High n-6 Polyunsaturated Fat Diet', 'description': 'n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Weight loss', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Re-located', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unable to comply', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruited in three cohorts between November 2009 and June 2012.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '195', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'High Saturated Fat Diet', 'description': 'SFA diet: Volunteers followed a high saturated fat diet for a 4-month period'}, {'id': 'BG001', 'title': 'High Monounsaturated Fat Diet', 'description': 'MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period'}, {'id': 'BG002', 'title': 'High n-6 Polyunsaturated Fat Diet', 'description': 'n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '9', 'groupId': 'BG000'}, {'value': '43', 'spread': '11', 'groupId': 'BG001'}, {'value': '45', 'spread': '10', 'groupId': 'BG002'}, {'value': '44', 'spread': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '195', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '26.3', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '27.0', 'spread': '3.7', 'groupId': 'BG002'}, {'value': '26.7', 'spread': '4.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist Circumference', 'classes': [{'categories': [{'measurements': [{'value': '92.1', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '88.2', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '92.1', 'spread': '13.1', 'groupId': 'BG002'}, {'value': '90.9', 'spread': '12.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '24-hour Systolic Blood Pressure (SBP)', 'classes': [{'categories': [{'measurements': [{'value': '121', 'spread': '12', 'groupId': 'BG000'}, {'value': '121', 'spread': '10', 'groupId': 'BG001'}, {'value': '124', 'spread': '11', 'groupId': 'BG002'}, {'value': '122', 'spread': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '24-hour Diastolic Blood Pressure (DBP)', 'classes': [{'categories': [{'measurements': [{'value': '75', 'spread': '8', 'groupId': 'BG000'}, {'value': '74', 'spread': '6', 'groupId': 'BG001'}, {'value': '76', 'spread': '8', 'groupId': 'BG002'}, {'value': '75', 'spread': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Total Cholesterol (TC)', 'classes': [{'categories': [{'measurements': [{'value': '5.38', 'spread': '0.98', 'groupId': 'BG000'}, {'value': '5.43', 'spread': '1.07', 'groupId': 'BG001'}, {'value': '5.57', 'spread': '1.27', 'groupId': 'BG002'}, {'value': '5.46', 'spread': '1.09', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting High-Density Lipoprotein Cholesterol (HDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'spread': '0.33', 'groupId': 'BG000'}, {'value': '1.48', 'spread': '0.39', 'groupId': 'BG001'}, {'value': '1.51', 'spread': '0.38', 'groupId': 'BG002'}, {'value': '1.48', 'spread': '0.37', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ratio of TC:HDL-C', 'classes': [{'categories': [{'measurements': [{'value': '3.92', 'spread': '1.20', 'groupId': 'BG000'}, {'value': '3.85', 'spread': '0.99', 'groupId': 'BG001'}, {'value': '3.85', 'spread': '1.12', 'groupId': 'BG002'}, {'value': '3.87', 'spread': '1.10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Low-Density Lipoprotein Cholesterol (LDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '3.67', 'spread': '0.93', 'groupId': 'BG000'}, {'value': '3.71', 'spread': '0.88', 'groupId': 'BG001'}, {'value': '3.81', 'spread': '1.13', 'groupId': 'BG002'}, {'value': '3.73', 'spread': '0.98', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Triacylglycerol (TAG)', 'classes': [{'categories': [{'measurements': [{'value': '1.31', 'spread': '0.77', 'groupId': 'BG000'}, {'value': '1.18', 'spread': '0.53', 'groupId': 'BG001'}, {'value': '1.26', 'spread': '0.67', 'groupId': 'BG002'}, {'value': '1.25', 'spread': '0.67', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Glucose', 'classes': [{'categories': [{'measurements': [{'value': '5.09', 'spread': '0.43', 'groupId': 'BG000'}, {'value': '5.00', 'spread': '0.45', 'groupId': 'BG001'}, {'value': '5.05', 'spread': '0.44', 'groupId': 'BG002'}, {'value': '5.05', 'spread': '0.44', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-12', 'studyFirstSubmitDate': '2011-11-16', 'resultsFirstSubmitDate': '2014-05-13', 'studyFirstSubmitQcDate': '2011-11-21', 'lastUpdatePostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-12', 'studyFirstPostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Flow Mediated Dilatation (FMD)', 'timeFrame': 'Baseline, 4 months'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular Risk Factors (Lipids, Inflammatory Markers, Indices of Insulin Resistance, Cell Microparticles, Endothelial Progenitor Cells)', 'timeFrame': '4 months', 'description': 'Data for fasting serum lipids (total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), TC:HDL-C ratio, low-density lipoprotein cholesterol (LDL-C), triacylglycerol (TAG)).'}, {'measure': '24-hour Ambulatory Blood Pressure', 'timeFrame': '4 months', 'description': '24-hour, daytime and night-time measures of systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP; SBP-DBP) and heart rate (HR)'}, {'measure': 'Vascular Stiffness by Pulse Wave Velocity (PWV), Pulse Wave Analysis (PWA) and Digital Volume Pulse (DVP)', 'timeFrame': '4 months', 'description': 'PWV (m/s) PWA produces Augmentation Index (AIx; %) DVP produces Stiffness Index (SI; m/s) and Reflection Index (RI; %)'}, {'measure': 'Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis)', 'timeFrame': '4 months', 'description': 'Laser Doppler imaging (LDI) with iontophoresis of acetylcholine (Ach; endothelium-dependent vasodilation) and sodium nitroprusside (SNP; endothelium-independent vasodilation).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fatty acids', 'cardiovascular disease', 'vascular function', 'microparticles'], 'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '37062359', 'type': 'DERIVED', 'citation': 'Sellem L, Eichelmann F, Jackson KG, Wittenbecher C, Schulze MB, Lovegrove JA. Replacement of dietary saturated with unsaturated fatty acids is associated with beneficial effects on lipidome metabolites: a secondary analysis of a randomized trial. Am J Clin Nutr. 2023 Jun;117(6):1248-1261. doi: 10.1016/j.ajcnut.2023.03.024. Epub 2023 Apr 11.'}, {'pmid': '29741564', 'type': 'DERIVED', 'citation': 'Weech M, Altowaijri H, Mayneris-Perxachs J, Vafeiadou K, Madden J, Todd S, Jackson KG, Lovegrove JA, Yaqoob P. Replacement of dietary saturated fat with unsaturated fats increases numbers of circulating endothelial progenitor cells and decreases numbers of microparticles: findings from the randomized, controlled Dietary Intervention and VAScular function (DIVAS) study. Am J Clin Nutr. 2018 Jun 1;107(6):876-882. doi: 10.1093/ajcn/nqy018.'}, {'pmid': '29169396', 'type': 'DERIVED', 'citation': 'Shatwan IM, Weech M, Jackson KG, Lovegrove JA, Vimaleswaran KS. Apolipoprotein E gene polymorphism modifies fasting total cholesterol concentrations in response to replacement of dietary saturated with monounsaturated fatty acids in adults at moderate cardiovascular disease risk. Lipids Health Dis. 2017 Nov 23;16(1):222. doi: 10.1186/s12944-017-0606-3.'}, {'pmid': '26016869', 'type': 'DERIVED', 'citation': 'Vafeiadou K, Weech M, Altowaijri H, Todd S, Yaqoob P, Jackson KG, Lovegrove JA. Replacement of saturated with unsaturated fats had no impact on vascular function but beneficial effects on lipid biomarkers, E-selectin, and blood pressure: results from the randomized, controlled Dietary Intervention and VAScular function (DIVAS) study. Am J Clin Nutr. 2015 Jul;102(1):40-8. doi: 10.3945/ajcn.114.097089. Epub 2015 May 27.'}, {'pmid': '24717370', 'type': 'DERIVED', 'citation': 'Weech M, Vafeiadou K, Hasaj M, Todd S, Yaqoob P, Jackson KG, Lovegrove JA. Development of a food-exchange model to replace saturated fat with MUFAs and n-6 PUFAs in adults at moderate cardiovascular risk. J Nutr. 2014 Jun;144(6):846-55. doi: 10.3945/jn.114.190645. Epub 2014 Apr 9.'}]}, 'descriptionModule': {'briefSummary': "It is well established that diet plays an important role in both the development and progression of heart disease. Different types of dietary fat have varying effects on heart disease risk factors. The elasticity of an individual's blood vessels is strongly associated with heart disease risk and recent evidence suggests that dietary manipulation may influence elasticity of the blood vessels with dietary fat (including saturated, monounsaturated and polyunsaturated fatty acids) as a potentially important modulator. Substantial evidence exists on the effects of monounsaturated fats (type of fatty acids mainly found in olive and rapeseed oil), n-6 polyunsaturated fats (type of polyunsaturated fatty acids found in vegetable oils) and saturated fat (found mainly in animal derived products) on lipid levels. However, the influence of these dietary fats on the elasticity of blood vessels remains unclear.The main purpose of the DIVAS study is to determine the effects of the substitution of saturated fats with either n-6 polyunsaturated or monounsaturated fats on blood vessel elasticity and to determine the effects of these different dietary fats on other risk factors for heart disease including lipoproteins and inflammatory biomarkers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults should have a relative risk (RR) of \\> 1.5 of developing cardiovascular disease (CVD) based on presenting with at least one recognised risk factor for CVD:\n\n* total cholesterol (TC) \\> 6.0 mmol/l\n* HDL cholesterol (HDLC) ≤ 1.0 mmol/l male, ≤ 1.3 mmol/l female\n* Glucose ≥ 6 mmol/l\n* Stage 1 hypertension or above i.e. a systolic BP ≥ 140 mmHg, diastolic BP ≥ 90 mmHg\n* BMI 28-35 kg/m2\n* waist \\>102 cm male or \\> 84 cm female\n* Adults with a first degree relative with either a history of premature CVD - age of onset younger than 55 y in fathers, sons or brothers or younger than 65 y in mothers, daughters or sisters, or type 2 diabetes.\n\nExclusion Criteria:\n\n* having suffered a myocardial infarction/stroke in the past 12 months\n* diabetic (diagnosed or fasting glucose \\> 7 mmol/l) or suffer from other endocrine disorders\n* suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis\n* on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation\n* no history of alcohol abuse\n* planning or on a weight reducing regime\n* taking any fish oil, fatty acid or vitamin and mineral supplements\n* pregnant, lactating or planning a pregnancy\n* smokers'}, 'identificationModule': {'nctId': 'NCT01478958', 'acronym': 'DIVAS', 'briefTitle': 'Dietary Intervention and Vascular Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Reading'}, 'officialTitle': 'The Effects of the Substitution of Dietary SFA With n-6 PUFA or MUFA on Vascular Function', 'orgStudyIdInfo': {'id': 'N02044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'high saturated fat diet', 'interventionNames': ['Dietary Supplement: SFA diet']}, {'type': 'EXPERIMENTAL', 'label': 'high monounsaturated fat diet', 'interventionNames': ['Dietary Supplement: MUFA diet']}, {'type': 'EXPERIMENTAL', 'label': 'high n-6 polyunsaturated fat diet', 'interventionNames': ['Dietary Supplement: n-6 PUFA diet']}], 'interventions': [{'name': 'SFA diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Volunteers are following a high saturated fat diet for a 4-month period', 'armGroupLabels': ['high saturated fat diet']}, {'name': 'MUFA diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Volunteers are following a high monounsaturated fat diet for a 4-month period', 'armGroupLabels': ['high monounsaturated fat diet']}, {'name': 'n-6 PUFA diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Volunteers are following a high n-6 polyunsaturated fat diet for a 4-month period', 'armGroupLabels': ['high n-6 polyunsaturated fat diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RG6 6AP', 'city': 'Reading', 'state': 'Berkshire', 'country': 'United Kingdom', 'facility': 'Department of Food and Nutritional Sciences, University of Reading', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'zip': 'RG6 6AP', 'city': 'Reading', 'state': 'Berkshire', 'country': 'United Kingdom', 'facility': 'University of Reading', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'overallOfficials': [{'name': 'Julie A Lovegrove, BSc PhD RNutr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Reading'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Reading', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Julie Lovegrove', 'investigatorAffiliation': 'University of Reading'}}}}