Skip to main content
OpenTrials
Completed

NCT Number: NCT02144454

Impact of Meal Fatty Acids on Postprandial Vascular Reactivity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Saturated fat

Dietary Supplement

Other names: SFA

Monounsaturated fat

Dietary Supplement

Other names: MUFA

n-6 polyunsaturated fat

Dietary Supplement

Other names: n-6 PUFA

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

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Department of Health, United Kingdom

Registry information

Official study title

The Acute Effects of Meals Rich in Saturated, Monounsaturated and n-6 Polyunsaturated Fatty Acids on Vascular Function

Acronym: DIVAS-2

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 22, 2014
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.