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Physiological Mechanisms Underlying the Effects of PUFA and Antioxidants on Postprandial Lipemia, Oxidative Stress, Endothelial Dysfunction and Inflammation in Men


Phase 2/Phase 3
18 Years
70 Years
Not Enrolling
Male
Cardiovascular Diseases, Vasodilation

Thank you

Trial Information

Physiological Mechanisms Underlying the Effects of PUFA and Antioxidants on Postprandial Lipemia, Oxidative Stress, Endothelial Dysfunction and Inflammation in Men


Inclusion Criteria:



- Waist circumference > 90 cm

- Fasting triglycerides > 1.7 mmol/L

- No use (ever) of medications for the treatment for dyslipidemia or hypertension

Exclusion Criteria:

- Alcohol consumption > 1 drink per day i.e ~15 g of alcohol/day or the equivalent of 1
beer (12 oz or 341 mL), 1 glass of wine (4 oz or 125 mL) or 1 ounce (30 mL) of
liquor.

- Chronic use of supplements (vitamins, minerals or flavonoids)

- Body mass index > 35 kg/m2

- Chronic diseases: CHD, diabetes, etc.

- Smokers (1 or more cigarette/day)

- Dyslipidemia secondary to renal insufficiency, hypothyroidism or others

- Any prior or current use of medications known to affect lipoprotein-lipid metabolism
(e.g. statins, fibrates), endothelial function (hypotensive drugs). Use (ever) of
anticoagulant drugs (e.g. warfarin) because of possible detrimental interaction with
the consumption of cranberry juice. Current or recent (<2 weeks) use of
anti-inflammatory drugs Note: If for any reason, a subject would have to go an any of
these drugs during the protocol, they would be automatically dropped from the study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

Changes in postprandial lipemia, oxidative stress, endothelial activation and inflammation: TG (plasma, chylomicron and VLDL), OxLDL, 8-iso-PGF2alpha, ICAM-1, VCAM-1, E-selectin and CRP concentrations

Outcome Time Frame:

June 2008

Principal Investigator

Charles Couillard, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Laval University

Authority:

Canada: Ethics Review Committee

Study ID:

MOP-64438

NCT ID:

NCT00296595

Start Date:

February 2006

Completion Date:

December 2008

Related Keywords:

  • Cardiovascular Diseases
  • Vasodilation
  • Cardiovascular Diseases

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