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
Information provided by (Responsible Party):
University Hospital, Rouen Identifier:
First received: December 8, 2011
Last updated: June 13, 2012
Last verified: June 2012

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.

Condition Intervention
Essential Hypertension
Metabolic Syndrome
Dietary Supplement: omega-3 from vegetal origin
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Cardiovascular Impact of Omega-3 Dietary Supplement From Vegetal Origin in Hypertension Associated With Metabolic Syndrome

Resource links provided by NLM:

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Brachial artery flow-mediated dilatation [ Time Frame: 6 months after omega-3 supplementation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aortic stiffness [ Time Frame: 6 months after omega-3 supplementation ] [ Designated as safety issue: No ]
    carotid-to-femoral pulse wave velocity

Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: omega-3 from vegetal origin Dietary Supplement: omega-3 from vegetal origin
6 months of supplementation with omega-3 from vegetal origin
Other Name: Cyclodextrin/Camelin oil
Placebo Comparator: Placebo Dietary Supplement: Placebo
6 months of supplementation with placebo
Other Name: Cyclodextrin/Starch


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01566188

Contact: Robinson Joannides, MD, PhD +33232889141

Mahes Hospital Recruiting
Fleury-Mérogis, France, 91700
Contact: Bruno Pannier, MD, PhD    +33169256514   
Principal Investigator: Bruno Pannier, MD, PhD         
George Pompidou European Hospital Recruiting
Paris, France, 75000
Contact: Pierre Boutouyrie, MD, PhD    +33153988021   
Principal Investigator: Pierre Boutouyrie, MD, PhD         
Rouen University Hospital Recruiting
Rouen, France, 76031
Contact: Jeremy Bellien, PharmD, PhD    +33232881428   
Sub-Investigator: Jeremy Bellien, PharmD, PhD         
Rangueil University Hospital Recruiting
Toulouse, France, 31059
Contact: Alessandra , Bura-Riviere    +33561322438   
Principal Investigator: Alessandra Bura-Riviere, MD, PhD         
Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: Robinson Joannides, MD, PhD Rouen University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Rouen Identifier: NCT01566188     History of Changes
Other Study ID Numbers: 2010/010 HP
Study First Received: December 8, 2011
Last Updated: June 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases processed this record on August 28, 2014