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Vascular Effects of Triglyceride-rich Lipoproteins

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01618071
Recruitment Status : Completed
First Posted : June 13, 2012
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
Royal Veterinary College
Information provided by (Responsible Party):
Dr Wendy Hall, King's College London

Tracking Information
First Submitted Date  ICMJE June 8, 2012
First Posted Date  ICMJE June 13, 2012
Last Update Posted Date September 16, 2019
Study Start Date  ICMJE June 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2012)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change in digital volume pulse stiffness index [ Time Frame: 0, 2, 4 and 6 h post-meal ]
  • Change in digital volume pulse reflection index [ Time Frame: 0, 2, 4 and 6 h post-meal ]
  • Change in plasma nitrite/nitrate concentrations [ Time Frame: 0, 2, 4 and 6 h ]
  • Change in plasma 8-isoprostane F2alpha concentrations [ Time Frame: 0, 2, 4 and 6 h post-meal ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vascular Effects of Triglyceride-rich Lipoproteins
Official Title  ICMJE Unravelling the Mechanisms of Vascular Protection by n3-PUFAs to Optimise and Support Their Use as Bioactives by the Food Industry
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Postprandial Period
  • Lipemia
  • Vasodilation
  • Vascular Resistance
  • Nitric Oxide
Intervention  ICMJE Dietary Supplement: High-fat meals varying in their fatty acid composition
70 g fat incorporated into a muffin and milkshake meal, consumed following fasting baseline measurements
Other Names:
  • DHASCO
  • Purified fish oil
Study Arms  ICMJE
  • Active Comparator: Oleic acid
    75 g high oleic acid sunflower oil.
    Intervention: Dietary Supplement: High-fat meals varying in their fatty acid composition
  • Active Comparator: Linoleic acid
    75 g high linoleic acid sunflower oil.
    Intervention: Dietary Supplement: High-fat meals varying in their fatty acid composition
  • Experimental: Eicosapentaenoic acid and docosahexaenoic acid
    5 g EPA and DHA derived from fish oil, made up to a total of 75 g with high oleic sunflower oil.
    Intervention: Dietary Supplement: High-fat meals varying in their fatty acid composition
  • Experimental: Docosahexaenoic acid
    5 g DHA derived from algal oil, made up to a total of 75 g with high oleic sunflower oil.
    Intervention: Dietary Supplement: High-fat meals varying in their fatty acid composition
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 11, 2012)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01618071
Other Study ID Numbers  ICMJE DRINC 11-LO-0116
BB/1005862/1 ( Other Grant/Funding Number: BBSRC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Wendy Hall, King's College London
Study Sponsor  ICMJE King's College London
Collaborators  ICMJE Royal Veterinary College
Investigators  ICMJE
Principal Investigator: Wendy L Hall, PhD King's College London
PRS Account King's College London
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP