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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Hospital, Rouen.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01566188
First received: December 8, 2011
Last updated: June 13, 2012
Last verified: June 2012

December 8, 2011
June 13, 2012
January 2011
January 2013   (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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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
Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
January 2013
January 2013   (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.
Both
18 Years to 70 Years
No
Contact: Robinson Joannides, MD, PhD +33232889141 robinson.joannides@chu-rouen.fr
France
 
NCT01566188
2010/010 HP
Yes
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Robinson Joannides, MD, PhD Rouen University Hospital
University Hospital, Rouen
June 2012

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