Impact of Meal Fatty Acids on Postprandial Vascular Reactivity

NCT02144454 | Completed DMC

• 1 other identifier: 024/0036
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease

Keywords

Cardiovascular disease; Fatty acids; Vascular function; Blood pressure; Plasma lipids; Insulin resistance; Endothelial activation

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (8)

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

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

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

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

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

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

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

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

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

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

Study Arms (3)

Meal rich in saturated fats

ACTIVE COMPARATOR

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

Dietary Supplement: Saturated fat

Meal rich in monounsaturated fats

EXPERIMENTAL

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

Dietary Supplement: Monounsaturated fat

Meal rich in n-6 polyunsaturated fats

EXPERIMENTAL

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

Saturated fat DIETARY_SUPPLEMENT

Also known as: SFA

Meal rich in saturated fats

Monounsaturated fat DIETARY_SUPPLEMENT

Also known as: MUFA

Meal rich in monounsaturated fats

n-6 polyunsaturated fat DIETARY_SUPPLEMENT

Also known as: n-6 PUFA

Meal rich in n-6 polyunsaturated fats

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead
• Department of Health, United Kingdom: collaborator

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33693945 DERIVED

• 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.

  PMID: 29546297 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Insulin Resistance

Interventions

Fatty Acids

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lipids

Study Officials

• Julie A Lovegrove, BSc PhD RNutr

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Julie Lovegrove

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 22, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

GB (1)