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Impact of Meal Fatty Acids on Postprandial Vascular Reactivity

NCT ID: NCT02144454

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Meal rich in saturated fats

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

Group Type ACTIVE_COMPARATOR

Saturated fat

Intervention Type DIETARY_SUPPLEMENT

Meal rich in monounsaturated fats

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

Group Type EXPERIMENTAL

Monounsaturated fat

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

n-6 polyunsaturated fat

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Saturated fat

Intervention Type DIETARY_SUPPLEMENT

Monounsaturated fat

Intervention Type DIETARY_SUPPLEMENT

n-6 polyunsaturated fat

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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SFA MUFA n-6 PUFA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Health, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Julie Lovegrove

Professor Julie Lovegrove

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie A Lovegrove, BSc PhD RNutr

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

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University of Reading

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 33693945 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29546297 (View on PubMed)

Other Identifiers

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024/0036

Identifier Type: -

Identifier Source: org_study_id