Cardiovascular DiseaseDIVAS-2NCT02144454
Impact of Meal Fatty Acids on Postprandial Vascular Reactivity
A study testing Saturated fat, Monounsaturated fat and n-6 polyunsaturated fat in people with Cardiovascular Disease, run by University of Reading at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Saturated fat, Monounsaturated fat and n-6 polyunsaturated fat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Planning or on a weight reducing regime
- Taking nutritional supplements (e.g. fish oil, calcium)
- Anaemic: haemoglobin <11.5 g/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effects of Meals Rich in Saturated, Monounsaturated and n-6 Polyunsaturated Fatty Acids on Vascular Function
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
- Being tested
- Saturated fat, Monounsaturated fat, n-6 polyunsaturated fat
- Keywords
- Cardiovascular disease, Fatty acids, Vascular function, Blood pressure, Plasma lipids, Insulin resistance, Endothelial activation
- Medical subject headings
- Cardiovascular Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saturated fatDietary supplement
Also called SFA
Monounsaturated fatDietary supplement
Also called MUFA
n-6 polyunsaturated fatDietary supplement
Also called n-6 PUFA
| Study group | Role | What they receive |
|---|---|---|
| Meal rich in saturated fats | Active comparator | Subjects are asked to consume a breakfast (0 min) and lunch (330 min) rich in saturated fats Receives: 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 Receives: 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 Receives: Dietary Supplement: n-6 polyunsaturated fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in vascular reactivity measured by flow-mediated dilatation (FMD)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Acute study: taken at 30 min intervals between 0 min (baseline) and 480 min
Change from baseline in nitric oxide (total plasma nitrates and nitrites)
Measured: Acute study: 0 (baseline), 180, 300 and 420 min
Change from baseline in plasma markers of endothelial activation (e.g. E-selectin, P-selectin, vascular cell adhesion molecule (VCAM-1))
Measured: Acute study: 0 (baseline), 180, 300 and 420 min
Change from baseline in plasma phospholipid fatty acid composition
Measured: Acute study: 0 (baseline), 180, 300 and 420 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, United Kingdom
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Julie A Lovegrove, BSc PhD RNutr, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144454
- Sponsor's protocol ID
- 024/0036
- Acronym
- DIVAS-2
- Status last verified
- Dec 2015
- First submitted
- 15 May 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 33693945Rathnayake 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Meals Rich in Saturated, Monounsaturated and n-6 Polyunsaturated Fatty Acids on Vascular Function
- ClinicalTrials.gov ID
- NCT02144454
- Acronym / sponsor ID
- DIVAS-2 / 024/0036
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular disease, Fatty acids, Vascular function, Blood pressure, Plasma lipids, Insulin resistance, Endothelial activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Department of Health, United Kingdom
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meal rich in saturated fats | Active comparator | Dietary Supplement: Saturated fatSubjects are asked to consume a breakfast (0 min) and lunch (330 min) rich in saturated fats |
| Meal rich in monounsaturated fats | Experimental | Dietary Supplement: Monounsaturated fatSubjects are asked to consume a breakfast (0 min) and lunch (330 min) rich in monounsaturated fats |
| Meal rich in n-6 polyunsaturated fats | Experimental | Dietary Supplement: n-6 polyunsaturated fatSubjects are asked to consume a breakfast (0 min) and lunch (330 min) rich in n-6 polyunsaturated fats |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saturated fatAlso: SFA | Dietary supplement | Meal rich in saturated fats |
| Monounsaturated fatAlso: MUFA | Dietary supplement | Meal rich in monounsaturated fats |
| n-6 polyunsaturated fatAlso: n-6 PUFA | Dietary supplement | Meal rich in n-6 polyunsaturated fats |
Primary outcome
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
8 secondary outcomes
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
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
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
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
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
Change from baseline in nitric oxide (total plasma nitrates and nitrites)
Time frame: Acute study: 0 (baseline), 180, 300 and 420 min
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
Change from baseline in plasma phospholipid fatty acid composition
Time frame: Acute study: 0 (baseline), 180, 300 and 420 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Derived from this study: PubMed 33693945Rathnayake 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.
- Derived from this study: PubMed 29546297Rathnayake 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A Lovegrove, BSc PhD RNutr principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saturated fat, Monounsaturated fat and n-6 polyunsaturated fat in people with Cardiovascular Disease, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02144454, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.