We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01566188
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : September 3, 2014
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:
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 or disease Intervention/treatment
Essential Hypertension Metabolic Syndrome Dietary Supplement: omega-3 from vegetal origin Dietary Supplement: Placebo

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Cardiovascular Impact of Omega-3 Dietary Supplement From Vegetal Origin in Hypertension Associated With Metabolic Syndrome
Study Start Date : January 2011
Primary Completion Date : January 2014
Study Completion Date : January 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Brachial artery flow-mediated dilatation [ Time Frame: 6 months after omega-3 supplementation ]

Secondary Outcome Measures :
  1. Aortic stiffness [ Time Frame: 6 months after omega-3 supplementation ]
    carotid-to-femoral pulse wave velocity

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566188

Mahes Hospital
Fleury-Mérogis, France, 91700
George Pompidou European Hospital
Paris, France, 75000
Rouen University Hospital
Rouen, France, 76031
Rangueil University Hospital
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: Robinson Joannides, MD, PhD Rouen University Hospital

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01566188     History of Changes
Other Study ID Numbers: 2010/010 HP
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases