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Completed

NCT Number: NCT01618071

Vascular Effects of Triglyceride-rich Lipoproteins

Many types of cardiovascular disease begin when the layer of cells lining blood vessels (endothelial cells) start to function abnormally. This causes white blood cells (monocytes) to enter the blood vessel wall and eventually form lesions. Fats from foods we consume are carried in the blood for 3-8 hours after a fatty meal in small particles known as chylomicrons (CM) and chylomicron remnants (CMR). The overall aim of this project is to investigate the idea that n-3 polyunsaturated fatty acids (PUFA) protect against heart disease by modifying the effect of CMR on endothelial cells and monocytes. We hypothesize that n3-PUFA carried in CMR reduce detrimental events which promote blood vessel damage and activate protective mechanisms to improve the function of arteries.

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Key information

Conditions

Postprandial Period Aneurysm Cardiovascular Diseases Dyslipidemias Hyperlipidemias Lipemia Lipid Metabolism Disorders Metabolic Diseases Nitric Oxide Nutritional and Metabolic Diseases Vascular Diseases Vascular Resistance Vasodilation

Age range

35 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes & Nutritional Sciences Division, King's College London

London, SE1 9NH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males
  • Non-smokers
  • Aged 35-70 years
  • Fasting TAG concentrations ≥1.2 mmol/L.

Exclusion criteria

  • Reported history of CVD (myocardial infarction, angina, venous thrombosis, stroke), impaired fasting glucose/uncontrolled type 2 diabetes (or fasting glucose ≥ 6.1 mmol/L), cancer, kidney, liver or bowel disease.
  • Presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption.
  • History of substance abuse or alcoholism (previous weekly alcohol intake >60 units/men)
  • Current self-reported weekly alcohol intake exceeding 28 units
  • Allergy or intolerance to any component of test meals
  • Unwilling to restrict consumption of any source of fish oil for the length of the study
  • Weight change of >3kg in preceding 2 months
  • Body Mass Index <20 and >35 kg/m2
  • Fasting blood cholesterol > 7.8 mmol/L
  • Current cigarette smoker.
  • Current use of lipid lowering medication

Treatment and study plan

High-fat meals varying in their fatty acid composition

Dietary Supplement

70 g fat incorporated into a muffin and milkshake meal, consumed following fasting baseline measurements

Other names: DHASCO, Purified fish oil

Primary outcomes

  1. Activation of inflammatory/oxidative stress pathways within cultured endothelial cells following treatment with 6 h postprandial chylomicron remnant-rich lipoprotein fraction

    Time frame: 6 h post-meal

    The primary outcome of the study is activation of inflammatory/oxidative stress pathways within cultured endothelial cells following incubation with pooled postprandial lipoprotein fractions rich in chylomicron remnants. Due to the nature of this type of research this necessitates more than one primary outcome measure: the primary measures are NF-kappa-beta activation, cytokine production (e.g. interleukin-6) and reactive oxygen species generation in the cultured human endothelial cells.

Secondary outcomes

  1. Incremental area under the plasma concentration versus time curve (iAUC) of triacylglycerol

    Time frame: 0, 1, 2, 3, 4, 5 and 6 h post-meal

  2. Incremental area under the plasma concentration versus time curve (iAUC) of glucose

    Time frame: 0, 1, 2, 3, 4, 5 and 6 h post-meal

  3. Incremental area under the plasma concentration versus time curve (iAUC) for non-esterified fatty acids

    Time frame: 0, 1, 2, 3, 4, 5 and 6 h post-meal

  4. Incremental area under the plasma concentration versus time curve (iAUC) for plasma fatty acid composition (%)

    Time frame: 0, 1, 2, 3, 4, 5 and 6 h post-meal

  5. Incremental area under the plasma concentration versus time curve (iAUC) for cholesterol

    Time frame: 0, 1, 2, 3, 4, 5 and 6 h post-meal

  6. Incremental area under the unit measure versus time curve for brachial augmentation index

    Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min post-meal

  7. Incremental area under the unit measure versus time curve for systolic blood pressure

    Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min post-meal

  8. Incremental area under the unit measure versus time curve for diastolic blood pressure

    Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min post-meal

  9. Change in digital volume pulse stiffness index

    Time frame: 0, 2, 4 and 6 h post-meal

  10. Change in digital volume pulse reflection index

    Time frame: 0, 2, 4 and 6 h post-meal

  11. Change in plasma nitrite/nitrate concentrations

    Time frame: 0, 2, 4 and 6 h

  12. Change in plasma 8-isoprostane F2alpha concentrations

    Time frame: 0, 2, 4 and 6 h post-meal

  13. Activation of inflammatory/oxidative stress pathways within cultured endothelial cells following treatment with 4 h postprandial chylomicron remnant-rich lipoprotein fraction

    Time frame: 4 h post-meal

  14. Activation of inflammatory/oxidative stress pathways within cultured endothelial cells following treatment with 5 h postprandial chylomicron remnant-rich lipoprotein fraction

    Time frame: 5 h post-meal

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Royal Veterinary College

Registry information

Official study title

Unravelling the Mechanisms of Vascular Protection by n3-PUFAs to Optimise and Support Their Use as Bioactives by the Food Industry

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 13, 2012
Registry last updated
Sep 16, 2019

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.

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