N/A
N=202
Dietary Intervention and Vascular Function
Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT01478958 ↗Enrolled (actual)
202
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Percent Change in Flow Mediated Dilatation (FMD) — -0.39; -0.07; -0.08 post-occlusion diameter change as % — p=0.238
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SFA diet (Dietary_supplement); MUFA diet (Dietary_supplement); n-6 PUFA diet (Dietary_supplement)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Reading
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Flow Mediated Dilatation (FMD) |
-0.39; -0.07; -0.08 | 0.238 |
| SECONDARY Cardiovascular Risk Factors (Lipids, Inflammatory Markers, Indices of Insulin Resistance, Cell Microparticles, Endothelial Progenitor Cells) |
— | — |
| SECONDARY 24-hour Ambulatory Blood Pressure |
— | — |
| SECONDARY Vascular Stiffness by Pulse Wave Velocity (PWV), Pulse Wave Analysis (PWA) and Digital Volume Pulse (DVP) |
— | — |
| SECONDARY Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis) |
— | — |
Summary
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.
Eligibility Criteria
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:
- total cholesterol (TC) > 6.0 mmol/l
- HDL cholesterol (HDLC) ≤ 1.0 mmol/l male, ≤ 1.3 mmol/l female
- Glucose ≥ 6 mmol/l
- Stage 1 hypertension or above i.e. a systolic BP ≥ 140 mmHg, diastolic BP ≥ 90 mmHg
- BMI 28-35 kg/m2
- waist >102 cm male or > 84 cm female
- 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.
Exclusion Criteria
- having suffered a myocardial infarction/stroke in the past 12 months
- diabetic (diagnosed or fasting glucose > 7 mmol/l) or suffer from other endocrine disorders
- suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis
- on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
- no history of alcohol abuse
- planning or on a weight reducing regime
- taking any fish oil, fatty acid or vitamin and mineral supplements
- pregnant, lactating or planning a pregnancy
- smokers
Data sourced from ClinicalTrials.gov (NCT01478958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.