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Vascular Effects of Triglyceride-rich Lipoproteins

K

King's College London

Status

Completed

Conditions

Postprandial Period
Vasodilation
Vascular Resistance
Nitric Oxide
Lipemia

Treatments

Dietary Supplement: High-fat meals varying in their fatty acid composition

Study type

Interventional

Funder types

Other

Identifiers

NCT01618071
DRINC 11-LO-0116
BB/1005862/1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

16 estimated patients

Sex

Male

Ages

35 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

16 participants in 4 patient groups

Oleic acid
Active Comparator group
Description:
75 g high oleic acid sunflower oil.
Treatment:
Dietary Supplement: High-fat meals varying in their fatty acid composition
Linoleic acid
Active Comparator group
Description:
75 g high linoleic acid sunflower oil.
Treatment:
Dietary Supplement: High-fat meals varying in their fatty acid composition
Eicosapentaenoic acid and docosahexaenoic acid
Experimental group
Description:
5 g EPA and DHA derived from fish oil, made up to a total of 75 g with high oleic sunflower oil.
Treatment:
Dietary Supplement: High-fat meals varying in their fatty acid composition
Docosahexaenoic acid
Experimental group
Description:
5 g DHA derived from algal oil, made up to a total of 75 g with high oleic sunflower oil.
Treatment:
Dietary Supplement: High-fat meals varying in their fatty acid composition

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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