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CompletedNCT02144454DIVAS-2Updated Dec 3, 2015

Impact of Meal Fatty Acids on Postprandial Vascular Reactivity

An interventional study of Saturated fat and Monounsaturated fat in Cardiovascular Disease, sponsored by University of Reading. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-03.

Sponsored by University of Reading · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
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Study summary

Cardiovascular disease (CVD) is the leading cause of death in women. Premenopausal women have a lower risk of CVD compared with men of a similar age. However, the incidence of CVD increases greatly after the menopause. The risk of heart disease is strongly associated with the health of an individual's blood vessels. It is thought that changes to the type of fat the investigators eat in their diet may affect the normal functioning and elasticity of the blood vessels, as well as affect cholesterol levels in the blood. Types of fat in the diet include monounsaturated fats (found mainly in olive oil), n-6 polyunsaturated fats (found mainly in sunflower oil) and saturated fats (found mainly in dairy products, such as butter and cheese). Since the investigators are in the fed (or postprandial) state for up to 18 hours of the day, it is important to see how these different fats affect the investigators blood vessels and blood fats over the course of the day after eating a meal. The aim of this study is to determine how consuming meals rich in saturated fats, n-6 polyunsaturated fats or monounsaturated fats influence the normal functioning and elasticity of the blood vessels throughout the day in postmenopausal women. A secondary aim is to determine the effects of these different dietary fats on a range of accepted heart disease risk markers including circulating levels of fats (lipids) and glucose in the blood.

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Conditions studied

  • Cardiovascular Disease

Keywords

  • Cardiovascular disease
  • Fatty acids
  • Vascular function
  • Blood pressure
  • Plasma lipids
  • Insulin resistance
  • Endothelial activation
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In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 32 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of Reading is the lead sponsor of 146 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Postmenopausal (not menstruated for at least 1 year)
  • Plasma triacylglycerol (TAG) between 0.8 and 4.0 mmol/l
  • Body mass index (BMI) between 18-35 kg/m2
  • Total cholesterol (TC): \<8 mmol/l
  • Systolic blood pressure \<160 mmHg and diastolic blood pressure \<100 mmHg
  • Non-smoker

Exclusion criteria

Exclusion Criteria:

  • Having suffered a myocardial infarction/stroke in the past 12 months
  • Diabetic (diagnosed as fasting blood glucose >7 mmol/l) or suffering from other endocrine disorders
  • Suffering from renal or bowel disease or have a history of cholestatic liver or pancreatitis
  • On drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
  • History of alcohol abuse
  • On hormone replacement therapy (HRT)
  • Planning or on a weight reducing regime
  • Taking nutritional supplements (e.g. fish oil, calcium)
  • Anaemic: haemoglobin \<11.5 g/dl
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    Meal rich in saturated fats

    Subjects are asked to consume a breakfast (0 min) and lunch (330 min) rich in saturated fats

    Dietary Supplement: Saturated fat

  • Experimental
    Meal rich in monounsaturated fats

    Subjects are asked to consume a breakfast (0 min) and lunch (330 min) rich in monounsaturated fats

    Dietary Supplement: Monounsaturated fat

  • Experimental
    Meal rich in n-6 polyunsaturated fats

    Subjects are asked to consume a breakfast (0 min) and lunch (330 min) rich in n-6 polyunsaturated fats

    Dietary Supplement: n-6 polyunsaturated fat

Interventions

  • Dietary supplementSaturated fat

    Also known as: SFA

  • Dietary supplementMonounsaturated fat

    Also known as: MUFA

  • Dietary supplementn-6 polyunsaturated fat

    Also known as: n-6 PUFA

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What researchers measure

Primary outcomes

  1. Change from baseline in vascular reactivity measured by flow-mediated dilatation (FMD)

    Time frame: Acute study: measured at 0 (baseline), 180, 300 and 420 min

Secondary outcomes

  1. Change from baseline in vascular reactivity measured by laser Doppler imaging with iontophoresis of acetylcholine (endothelium-dependent) and sodium nitroprusside (endothelium-independent)

    Time frame: Acute study: measured at 0 (baseline), 240 and 450 min

  2. Change from baseline in plasma lipids (primarily triacylglycerol, apolipoprotein B and non-esterified fatty acids)

    Time frame: Acute study: taken at 30 min intervals between 0 min (baseline) and 480 min

  3. Change from baseline in arterial stiffness measured by digital volume pulse (stiffness index and reflection index)

    Time frame: Acute study: taken at 0 (baseline), 240 amd 450 min

  4. Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure and pulse pressure)

    Time frame: Acute study: taken at 0 (baseline), 240 and 450 min

  5. Change from baseline in markers of insulin resistance (glucose, insulin, indices of insulin resistance/sensitivity)

    Time frame: Acute study: taken at 30 min intervals between 0 min (baseline) and 480 min

  6. Change from baseline in nitric oxide (total plasma nitrates and nitrites)

    Time frame: Acute study: 0 (baseline), 180, 300 and 420 min

  7. Change from baseline in plasma markers of endothelial activation (e.g. E-selectin, P-selectin, vascular cell adhesion molecule (VCAM-1))

    Time frame: Acute study: 0 (baseline), 180, 300 and 420 min

  8. Change from baseline in plasma phospholipid fatty acid composition

    Time frame: Acute study: 0 (baseline), 180, 300 and 420 min

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Study locations

1 site
  • University of Reading
    Reading, Berkshire RG6 6AP, United Kingdom
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References and documents

Publications

  • Rathnayake KM, Weech M, Lovegrove JA, Jackson KG. Glu298Asp (rs1799983) Polymorphism Influences Postprandial Vascular Reactivity and the Insulin Response to Meals of Varying Fat Composition in Postmenopausal Women: Findings from the Randomized, Controlled Dietary Intervention and VAScular function (DIVAS)-2 Study. J Nutr. 2021 Apr 8;151(4):848-856. doi: 10.1093/jn/nxaa394. PubMed 33693945 ↗
  • Rathnayake KM, Weech M, Jackson KG, Lovegrove JA. Meal Fatty Acids Have Differential Effects on Postprandial Blood Pressure and Biomarkers of Endothelial Function but Not Vascular Reactivity in Postmenopausal Women in the Randomized Controlled Dietary Intervention and VAScular function (DIVAS)-2 Study. J Nutr. 2018 Mar 1;148(3):348-357. doi: 10.1093/jn/nxx042. PubMed 29546297 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02144454
Lead sponsor
University of Reading
Collaborators
Department of Health, United Kingdom
Responsible party
Julie Lovegrove (Professor Julie Lovegrove, University of Reading) — Principal investigator
First posted
May 22, 2014
Start date
Jun 2014
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Dec 3, 2015

Study contacts

Julie A Lovegrove, BSc PhD RNutr
principal investigator · University of Reading

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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