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Dietary Intervention and Vascular Function (DIVAS)

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ClinicalTrials.gov Identifier: NCT01478958
Recruitment Status : Completed
First Posted : November 23, 2011
Results First Posted : July 15, 2014
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading

Tracking Information
First Submitted Date  ICMJE November 16, 2011
First Posted Date  ICMJE November 23, 2011
Results First Submitted Date  ICMJE May 13, 2014
Results First Posted Date  ICMJE July 15, 2014
Last Update Posted Date July 15, 2014
Study Start Date  ICMJE May 2010
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2014)
Percent Change in Flow Mediated Dilatation (FMD) [ Time Frame: Baseline, 4 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2011)
Vascular reactivity by Flow Mediated Dilatation (FMD) [ Time Frame: 4 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2014)
  • 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)).
  • 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)
  • 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; %)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2011)
  • Cardiovascular risk factors (cell microparticles, endothelial progenitor cells, lipids, inflammatory markers, indices of insulin resistance) [ Time Frame: 4 months ]
  • 24-hour Ambulatory Blood Pressure [ Time Frame: 4 months ]
  • Vascular Stiffness by Pulse Wave Velocity (PWV), Pulse Wave Analysis (PWA) and Digital Volume Pulse (DVP) [ Time Frame: 4 months ]
  • Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis) [ Time Frame: 4 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dietary Intervention and Vascular Function
Official Title  ICMJE The Effects of the Substitution of Dietary SFA With n-6 PUFA or MUFA on Vascular Function
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2014)
202
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2011)
228
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01478958
Other Study ID Numbers  ICMJE N02044
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julie Lovegrove, University of Reading
Study Sponsor  ICMJE University of Reading
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julie A Lovegrove, BSc PhD RNutr University of Reading
PRS Account University of Reading
Verification Date June 2014

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