Dietary Intervention and Vascular Function

NCT01478958 | Completed Results DMC

• 1 other identifier: N02044
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Disease

Keywords

fatty acids; cardiovascular disease; vascular function; microparticles

Outcome Measures

Primary Outcomes (1)

• Percent Change in Flow Mediated Dilatation (FMD)

  Baseline, 4 months

Secondary Outcomes (4)

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

  4 months

• 24-hour Ambulatory Blood Pressure

  4 months

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

  4 months

• Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis)

  4 months

Study Arms (3)

high saturated fat diet

ACTIVE COMPARATOR

Dietary Supplement: SFA diet

high monounsaturated fat diet

EXPERIMENTAL

Dietary Supplement: MUFA diet

high n-6 polyunsaturated fat diet

EXPERIMENTAL

Dietary Supplement: n-6 PUFA diet

Interventions

SFA diet DIETARY_SUPPLEMENT

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

high saturated fat diet

MUFA diet DIETARY_SUPPLEMENT

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

high monounsaturated fat diet

n-6 PUFA diet DIETARY_SUPPLEMENT

Volunteers are following a high n-6 polyunsaturated fat diet for a 4-month period

high n-6 polyunsaturated fat diet

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead

Study Sites (2)

Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Related Publications (5)

• Sellem L, Eichelmann F, Jackson KG, Wittenbecher C, Schulze MB, Lovegrove JA. Replacement of dietary saturated with unsaturated fatty acids is associated with beneficial effects on lipidome metabolites: a secondary analysis of a randomized trial. Am J Clin Nutr. 2023 Jun;117(6):1248-1261. doi: 10.1016/j.ajcnut.2023.03.024. Epub 2023 Apr 11.

  PMID: 37062359 DERIVED

• Weech M, Altowaijri H, Mayneris-Perxachs J, Vafeiadou K, Madden J, Todd S, Jackson KG, Lovegrove JA, Yaqoob P. Replacement of dietary saturated fat with unsaturated fats increases numbers of circulating endothelial progenitor cells and decreases numbers of microparticles: findings from the randomized, controlled Dietary Intervention and VAScular function (DIVAS) study. Am J Clin Nutr. 2018 Jun 1;107(6):876-882. doi: 10.1093/ajcn/nqy018.

  PMID: 29741564 DERIVED

• Shatwan IM, Weech M, Jackson KG, Lovegrove JA, Vimaleswaran KS. Apolipoprotein E gene polymorphism modifies fasting total cholesterol concentrations in response to replacement of dietary saturated with monounsaturated fatty acids in adults at moderate cardiovascular disease risk. Lipids Health Dis. 2017 Nov 23;16(1):222. doi: 10.1186/s12944-017-0606-3.

  PMID: 29169396 DERIVED

• Vafeiadou K, Weech M, Altowaijri H, Todd S, Yaqoob P, Jackson KG, Lovegrove JA. Replacement of saturated with unsaturated fats had no impact on vascular function but beneficial effects on lipid biomarkers, E-selectin, and blood pressure: results from the randomized, controlled Dietary Intervention and VAScular function (DIVAS) study. Am J Clin Nutr. 2015 Jul;102(1):40-8. doi: 10.3945/ajcn.114.097089. Epub 2015 May 27.

  PMID: 26016869 DERIVED

• 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.

  PMID: 24717370 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Professor Julie Lovegrove
• Organization: University of Reading

j.a.lovegrove@reading.ac.uk

+44 (0)118 3786418

Study Officials

• Julie A Lovegrove, BSc PhD RNutr

  University of Reading

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 23, 2011
• Study Start: May 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 15, 2014
• Results First Posted: July 15, 2014

Record last verified: 2014-06

Locations

GB (2)