We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Dietary Intervention and Vascular Function (DIVAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01478958
Recruitment Status : Completed
First Posted : November 23, 2011
Results First Posted : July 15, 2014
Last Update Posted : July 15, 2014
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Dietary Supplement: SFA diet Dietary Supplement: MUFA diet Dietary Supplement: n-6 PUFA diet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effects of the Substitution of Dietary SFA With n-6 PUFA or MUFA on Vascular Function
Study Start Date : May 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Active Comparator: high saturated fat diet Dietary Supplement: SFA diet
Volunteers are following a high saturated fat diet for a 4-month period

Experimental: high monounsaturated fat diet Dietary Supplement: MUFA diet
Volunteers are following a high monounsaturated fat diet for a 4-month period

Experimental: high n-6 polyunsaturated fat diet Dietary Supplement: n-6 PUFA diet
Volunteers are following a high n-6 polyunsaturated fat diet for a 4-month period

Primary Outcome Measures :
  1. Percent Change in Flow Mediated Dilatation (FMD) [ Time Frame: Baseline, 4 months ]

Secondary Outcome Measures :
  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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01478958

Layout table for location information
United Kingdom
Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, United Kingdom, RG6 6AP
University of Reading
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Layout table for investigator information
Principal Investigator: Julie A Lovegrove, BSc PhD RNutr University of Reading
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Julie Lovegrove, Professor, University of Reading
ClinicalTrials.gov Identifier: NCT01478958    
Other Study ID Numbers: N02044
First Posted: November 23, 2011    Key Record Dates
Results First Posted: July 15, 2014
Last Update Posted: July 15, 2014
Last Verified: June 2014
Keywords provided by Julie Lovegrove, University of Reading:
fatty acids
cardiovascular disease
vascular function
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases