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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high saturated fat diet | Active Comparator |
| |
| high monounsaturated fat diet | Experimental |
| |
| high n-6 polyunsaturated fat diet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SFA diet | Dietary Supplement | Volunteers are following a high saturated fat diet for a 4-month period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Flow Mediated Dilatation (FMD) | Baseline, 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Risk Factors (Lipids, Inflammatory Markers, Indices of Insulin Resistance, Cell Microparticles, Endothelial Progenitor Cells) | 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)). | 4 months |
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Inclusion Criteria:
Adults 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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie A Lovegrove, BSc PhD RNutr | University of Reading | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Food and Nutritional Sciences, University of Reading | Reading | Berkshire | RG6 6AP | United Kingdom | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37062359 | Derived | 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. | |
| 29741564 |
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Recruited in three cohorts between November 2009 and June 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Saturated Fat Diet | SFA diet: Volunteers followed a high saturated fat diet for a 4-month period |
| FG001 | High Monounsaturated Fat Diet | MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period |
| FG002 | High n-6 Polyunsaturated Fat Diet | n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Saturated Fat Diet | SFA diet: Volunteers followed a high saturated fat diet for a 4-month period |
| BG001 | High Monounsaturated Fat Diet | MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Flow Mediated Dilatation (FMD) | Number of participants analyzed: n=171. n=24 were images of poor quality that could not be analyzed successfully. | Posted | Mean | Standard Error | post-occlusion diameter change as % | Baseline, 4 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Saturated Fat Diet | SFA diet: Volunteers followed a high saturated fat diet for a 4-month period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Julie Lovegrove | University of Reading | +44 (0)118 3786418 | j.a.lovegrove@reading.ac.uk |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| MUFA diet | Dietary Supplement | Volunteers are following a high monounsaturated fat diet for a 4-month period |
|
| n-6 PUFA diet | Dietary Supplement | Volunteers are following a high n-6 polyunsaturated fat diet for a 4-month period |
|
| 24-hour Ambulatory Blood Pressure |
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) |
| 4 months |
| Vascular Stiffness by Pulse Wave Velocity (PWV), Pulse Wave Analysis (PWA) and Digital Volume Pulse (DVP) | PWV (m/s) PWA produces Augmentation Index (AIx; %) DVP produces Stiffness Index (SI; m/s) and Reflection Index (RI; %) | 4 months |
| Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis) | Laser Doppler imaging (LDI) with iontophoresis of acetylcholine (Ach; endothelium-dependent vasodilation) and sodium nitroprusside (SNP; endothelium-independent vasodilation). | 4 months |
| University of Reading |
| Reading |
| Berkshire |
| RG6 6AP |
| United Kingdom |
| 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. |
| 29169396 | Derived | 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. |
| 26016869 | Derived | 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. |
| 24717370 | Derived | 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. |
| Re-located |
|
| Unable to comply |
|
| BG002 | High n-6 Polyunsaturated Fat Diet | n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Waist Circumference | Mean | Standard Deviation | cm |
|
| 24-hour Systolic Blood Pressure (SBP) | Mean | Standard Deviation | mm Hg |
|
| 24-hour Diastolic Blood Pressure (DBP) | Mean | Standard Deviation | mm Hg |
|
| Fasting Total Cholesterol (TC) | Mean | Standard Deviation | mmol/L |
|
| Fasting High-Density Lipoprotein Cholesterol (HDL-C) | Mean | Standard Deviation | mmol/L |
|
| Ratio of TC:HDL-C | Mean | Standard Deviation |
|
| Fasting Low-Density Lipoprotein Cholesterol (LDL-C) | Mean | Standard Deviation | mmol/L |
|
| Fasting Triacylglycerol (TAG) | Mean | Standard Deviation | mmol/L |
|
| Fasting Glucose | Mean | Standard Deviation | mmol/L |
|
n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period |
|
|
|
| Secondary | Cardiovascular Risk Factors (Lipids, Inflammatory Markers, Indices of Insulin Resistance, Cell Microparticles, Endothelial Progenitor Cells) | 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)). | Not Posted | 4 months |
| Secondary | 24-hour Ambulatory Blood Pressure | 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) | Not Posted | 4 months |
| Secondary | Vascular Stiffness by Pulse Wave Velocity (PWV), Pulse Wave Analysis (PWA) and Digital Volume Pulse (DVP) | PWV (m/s) PWA produces Augmentation Index (AIx; %) DVP produces Stiffness Index (SI; m/s) and Reflection Index (RI; %) | Not Posted | 4 months |
| Secondary | Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis) | Laser Doppler imaging (LDI) with iontophoresis of acetylcholine (Ach; endothelium-dependent vasodilation) and sodium nitroprusside (SNP; endothelium-independent vasodilation). | Not Posted | 4 months |
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | High Monounsaturated Fat Diet | MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period | 0 | 66 | 0 | 66 |
| EG002 | High n-6 Polyunsaturated Fat Diet | n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period | 0 | 69 | 0 | 69 |
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