Vascular Effects of Triglyceride-rich Lipoproteins

NCT ID: NCT01618071

Last Updated: 2019-09-16

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-10-31

Brief Summary

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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

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Conditions

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Postprandial Period Lipemia Vasodilation Vascular Resistance Nitric Oxide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oleic acid

75 g high oleic acid sunflower oil.

Group Type ACTIVE_COMPARATOR

High-fat meals varying in their fatty acid composition

Intervention Type DIETARY_SUPPLEMENT

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

Linoleic acid

75 g high linoleic acid sunflower oil.

Group Type ACTIVE_COMPARATOR

High-fat meals varying in their fatty acid composition

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

High-fat meals varying in their fatty acid composition

Intervention Type DIETARY_SUPPLEMENT

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

Docosahexaenoic acid

5 g DHA derived from algal oil, made up to a total of 75 g with high oleic sunflower oil.

Group Type EXPERIMENTAL

High-fat meals varying in their fatty acid composition

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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High-fat meals varying in their fatty acid composition

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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DHASCO Purified fish oil

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Royal Veterinary College

UNKNOWN

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Dr Wendy Hall

Lecturer in Nutritional Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wendy L Hall, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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Diabetes & Nutritional Sciences Division, King's College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Lambert MS, Botham KM, Mayes PA. Modification of the fatty acid composition of dietary oils and fats on incorporation into chylomicrons and chylomicron remnants. Br J Nutr. 1996 Sep;76(3):435-45. doi: 10.1079/bjn19960048.

Reference Type BACKGROUND
PMID: 8881715 (View on PubMed)

Botham KM, Bravo E, Elliott J, Wheeler-Jones CP. Direct interaction of dietary lipids carried in chylomicron remnants with cells of the artery wall: implications for atherosclerosis development. Curr Pharm Des. 2005;11(28):3681-95. doi: 10.2174/138161205774580732.

Reference Type BACKGROUND
PMID: 16305504 (View on PubMed)

Proctor SD, Vine DF, Mamo JC. Arterial retention of apolipoprotein B(48)- and B(100)-containing lipoproteins in atherogenesis. Curr Opin Lipidol. 2002 Oct;13(5):461-70. doi: 10.1097/00041433-200210000-00001.

Reference Type BACKGROUND
PMID: 12352009 (View on PubMed)

Marcoux C, Hopkins PN, Wang T, Leary ET, Nakajima K, Davignon J, Cohn JS. Remnant-like particle cholesterol and triglyceride levels of hypertriglyceridemic patients in the fed and fasted state. J Lipid Res. 2000 Sep;41(9):1428-36.

Reference Type BACKGROUND
PMID: 10974050 (View on PubMed)

Hall WL, Sanders KA, Sanders TA, Chowienczyk PJ. A high-fat meal enriched with eicosapentaenoic acid reduces postprandial arterial stiffness measured by digital volume pulse analysis in healthy men. J Nutr. 2008 Feb;138(2):287-91. doi: 10.1093/jn/138.2.287.

Reference Type BACKGROUND
PMID: 18203893 (View on PubMed)

Burdge GC, Powell J, Dadd T, Talbot D, Civil J, Calder PC. Acute consumption of fish oil improves postprandial VLDL profiles in healthy men aged 50-65 years. Br J Nutr. 2009 Jul;102(1):160-5. doi: 10.1017/S0007114508143550. Epub 2009 Jan 13.

Reference Type BACKGROUND
PMID: 19138437 (View on PubMed)

Zampelas A, Peel AS, Gould BJ, Wright J, Williams CM. Polyunsaturated fatty acids of the n-6 and n-3 series: effects on postprandial lipid and apolipoprotein levels in healthy men. Eur J Clin Nutr. 1994 Dec;48(12):842-8.

Reference Type BACKGROUND
PMID: 7889892 (View on PubMed)

Armah CK, Jackson KG, Doman I, James L, Cheghani F, Minihane AM. Fish oil fatty acids improve postprandial vascular reactivity in healthy men. Clin Sci (Lond). 2008 Jun;114(11):679-86. doi: 10.1042/CS20070277.

Reference Type BACKGROUND
PMID: 18052925 (View on PubMed)

Rontoyanni VG, Hall WL, Pombo-Rodrigues S, Appleton A, Chung R, Sanders TA. A comparison of the changes in cardiac output and systemic vascular resistance during exercise following high-fat meals containing DHA or EPA. Br J Nutr. 2012 Aug;108(3):492-9. doi: 10.1017/S0007114511005721. Epub 2012 Feb 21.

Reference Type BACKGROUND
PMID: 22348439 (View on PubMed)

Purcell R, Latham SH, Botham KM, Hall WL, Wheeler-Jones CP. High-fat meals rich in EPA plus DHA compared with DHA only have differential effects on postprandial lipemia and plasma 8-isoprostane F2alpha concentrations relative to a control high-oleic acid meal: a randomized controlled trial. Am J Clin Nutr. 2014 Oct;100(4):1019-28. doi: 10.3945/ajcn.114.091223. Epub 2014 Aug 6.

Reference Type DERIVED
PMID: 25099540 (View on PubMed)

Related Links

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Other Identifiers

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BB/1005862/1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DRINC 11-LO-0116

Identifier Type: -

Identifier Source: org_study_id

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