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Impact of Meal Fatty Acids on Postprandial Vascular Reactivity

Information source: University of Reading
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiovascular Disease

Intervention: Saturated fat (Dietary Supplement); Monounsaturated fat (Dietary Supplement); n-6 polyunsaturated fat (Dietary Supplement)

Phase: N/A

Status: Recruiting

Sponsored by: University of Reading

Official(s) and/or principal investigator(s):
Julie A Lovegrove, BSc PhD RNutr, Principal Investigator, Affiliation: University of Reading

Overall contact:
Julie A Lovegrove, BSc PhD RNutr, Phone: +44 (0)118 378 6418, Email: j.a.lovegrove@reading.ac.uk

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Change from baseline in vascular reactivity measured by flow-mediated dilatation (FMD)

Secondary outcome:

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

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

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

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

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

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

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

Change from baseline in plasma phospholipid fatty acid composition

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Julie A Lovegrove, BSc PhD RNutr, Phone: +44 (0)118 378 6418, Email: j.a.lovegrove@reading.ac.uk

University of Reading, Reading, Berkshire RG6 6AP, United Kingdom; Recruiting
Julie A Lovegrove, Professor, Phone: +44 (0)118 378 6418, Email: j.a.lovegrove@reading.ac.uk
Michelle Weech, MBiochem MSc PhD, Email: m.weech@reading.ac.uk
Michelle Weech, MBiochem MSc PhD, Sub-Investigator
Kumari Rathnayake, BSc MPhil, Sub-Investigator
Kim Jackson, BSc PhD, Sub-Investigator
Parveen Yaqoob, MA PhD RNutr, Sub-Investigator
Susan Todd, BSc MSc PhD, Sub-Investigator
Julie A Lovegrove, BSc PhD RNutr, Principal Investigator
Additional Information

Starting date: June 2014
Last updated: October 2, 2014

Page last updated: August 23, 2015

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