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Completed

NCT Number: NCT01478958

Dietary Intervention and Vascular Function

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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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Nutritional Sciences, University of Reading, Reading, Berkshire, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SFA diet

Dietary Supplement

Volunteers are following a high saturated fat diet for a 4-month period

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

Primary outcomes

  1. Percent Change in Flow Mediated Dilatation (FMD)

    Time frame: Baseline, 4 months

Secondary outcomes

  1. Cardiovascular Risk Factors (Lipids, Inflammatory Markers, Indices of Insulin Resistance, Cell Microparticles, Endothelial Progenitor Cells)

    Time frame: 4 months

    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)).

  2. 24-hour Ambulatory Blood Pressure

    Time frame: 4 months

    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)

  3. Vascular Stiffness by Pulse Wave Velocity (PWV), Pulse Wave Analysis (PWA) and Digital Volume Pulse (DVP)

    Time frame: 4 months

    PWV (m/s) PWA produces Augmentation Index (AIx; %) DVP produces Stiffness Index (SI; m/s) and Reflection Index (RI; %)

  4. Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis)

    Time frame: 4 months

    Laser Doppler imaging (LDI) with iontophoresis of acetylcholine (Ach; endothelium-dependent vasodilation) and sodium nitroprusside (SNP; endothelium-independent vasodilation).

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Official study title

The Effects of the Substitution of Dietary SFA With n-6 PUFA or MUFA on Vascular Function

Acronym: DIVAS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 23, 2011
Registry last updated
Jul 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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