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Vascular Impact of Omega-3 in Metabolic Syndrome (CARDIOMEGA)

U

University Hospital, Rouen

Status

Completed

Conditions

Essential Hypertension
Metabolic Syndrome

Treatments

Dietary Supplement: omega-3 from vegetal origin
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01566188
2010/010 HP

Details and patient eligibility

About

The overall aims of the present project are to investigate the impact of a nutritional approach based on omega-3 from vegetal origin on vascular function in hypertension associated with metabolic syndrome.

Enrollment

95 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female and male patients with treated essential hypertension (blood pressure values<140/90 mmHg under antihypertensive treatment).
  • Presence of at least two of the following criteria of the metabolic syndrome: abdominal girth >102 cm in men or >88 cm in women, HDL-C<0.4 g/L in men or <0.5 g/L in women, fasting triglyceride >1.5 g/L (or specific treatment for these lipid abnormalities), fasting glucose >1.10 g/L.

Exclusion criteria

  • Secondary hypertension, myocardial infarction, coronary artery disease, cerebrovascular disease, stroke or transient ischemia, cardiac failure, diabetes (or fasting glucose>1.26 g/L) or renal failure (MDRD < 50 ml/min)
  • Severe hypercholesterolemia (total cholesterol > 2.5 g/l), alcohol or drug abuse, toxicomania, or clinically significant abnormalities in other current biological parameters.

Trial design

95 participants in 2 patient groups, including a placebo group

omega-3 from vegetal origin
Experimental group
Treatment:
Dietary Supplement: omega-3 from vegetal origin
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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