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Dietary Intervention and Vascular Function (DIVAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading
ClinicalTrials.gov Identifier:
NCT01478958
First received: November 16, 2011
Last updated: June 12, 2014
Last verified: June 2014

November 16, 2011
June 12, 2014
May 2010
October 2012   (final data collection date for primary outcome measure)
Percent Change in Flow Mediated Dilatation (FMD) [ Time Frame: Baseline, 4 months ] [ Designated as safety issue: No ]
Vascular reactivity by Flow Mediated Dilatation (FMD) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01478958 on ClinicalTrials.gov Archive Site
  • Cardiovascular Risk Factors (Lipids, Inflammatory Markers, Indices of Insulin Resistance, Cell Microparticles, Endothelial Progenitor Cells) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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)).
  • 24-hour Ambulatory Blood Pressure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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)
  • Vascular Stiffness by Pulse Wave Velocity (PWV), Pulse Wave Analysis (PWA) and Digital Volume Pulse (DVP) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    PWV (m/s) PWA produces Augmentation Index (AIx; %) DVP produces Stiffness Index (SI; m/s) and Reflection Index (RI; %)
  • Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Laser Doppler imaging (LDI) with iontophoresis of acetylcholine (Ach; endothelium-dependent vasodilation) and sodium nitroprusside (SNP; endothelium-independent vasodilation).
  • Cardiovascular risk factors (cell microparticles, endothelial progenitor cells, lipids, inflammatory markers, indices of insulin resistance) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • 24-hour ambulatory blood pressure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Vascular stiffness by pulse wave velocity (PWV), pulse wave analysis (PWA) and digital volume pulse (DVP) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Microvascular reactivity (Laser doppler imaging with Iontophoresis) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Dietary Intervention and Vascular Function
The Effects of the Substitution of Dietary SFA With n-6 PUFA or MUFA on 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Cardiovascular Disease
  • Dietary Supplement: SFA diet
    Volunteers are following a high saturated fat diet for a 4-month period
  • Dietary Supplement: MUFA diet
    Volunteers are following a high monounsaturated fat diet for a 4-month period
  • Dietary Supplement: n-6 PUFA diet
    Volunteers are following a high n-6 polyunsaturated fat diet for a 4-month period
  • Active Comparator: high saturated fat diet
    Intervention: Dietary Supplement: SFA diet
  • Experimental: high monounsaturated fat diet
    Intervention: Dietary Supplement: MUFA diet
  • Experimental: high n-6 polyunsaturated fat diet
    Intervention: Dietary Supplement: n-6 PUFA diet
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
21 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01478958
N02044
Yes
Julie Lovegrove, University of Reading
University of Reading
Not Provided
Principal Investigator: Julie A Lovegrove, BSc PhD RNutr University of Reading
University of Reading
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP