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

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Rouen Identifier:
First received: December 8, 2011
Last updated: September 1, 2014
Last verified: September 2014

December 8, 2011
September 1, 2014
January 2011
January 2014   (final data collection date for primary outcome measure)
Brachial artery flow-mediated dilatation [ Time Frame: 6 months after omega-3 supplementation ] [ Designated as safety issue: No ]
Brachial artery flow-mediated dilatation [ Time Frame: before and after 6 months omega-3 supplementation ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01566188 on Archive Site
Aortic stiffness [ Time Frame: 6 months after omega-3 supplementation ] [ Designated as safety issue: No ]
carotid-to-femoral pulse wave velocity
Aortic stiffness [ Time Frame: before and after 6 months omega-3 supplementation ] [ Designated as safety issue: No ]
Carotid-to-femoral pulse wave velocity
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Vascular Impact of Omega-3 in Metabolic Syndrome
Cardiovascular Impact of Omega-3 Dietary Supplement From Vegetal Origin in Hypertension Associated With Metabolic Syndrome

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.

Not Provided
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Essential Hypertension
  • Metabolic Syndrome
  • Dietary Supplement: omega-3 from vegetal origin
    6 months of supplementation with omega-3 from vegetal origin
    Other Name: Cyclodextrin/Camelin oil
  • Dietary Supplement: Placebo
    6 months of supplementation with placebo
    Other Name: Cyclodextrin/Starch
  • Experimental: omega-3 from vegetal origin
    Intervention: Dietary Supplement: omega-3 from vegetal origin
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
18 Years to 70 Years
Contact information is only displayed when the study is recruiting subjects
2010/010 HP
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Robinson Joannides, MD, PhD Rouen University Hospital
University Hospital, Rouen
September 2014

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