Vascular Impact of Omega-3 in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— CARDIOMEGA  

Official title:

Cardiovascular Impact of Omega-3 Dietary Supplement From Vegetal Origin in Hypertension Associated With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566188
• Other study ID #: 2010/010 HP
• Status: Completed
• Phase: N/A
• First received: December 8, 2011
• Last updated: September 1, 2014
• Start date: January 2011
• Est. completion date: January 2014

Study information

• Verified date: September 2014
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• omega-3 from vegetal origin
6 months of supplementation with omega-3 from vegetal origin
• Placebo
6 months of supplementation with placebo

Locations

Country	Name	City	State
France	Mahes Hospital	Fleury-Mérogis
France	George Pompidou European Hospital	Paris
France	Rouen University Hospital	Rouen
France	Rangueil University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial artery flow-mediated dilatation		6 months after omega-3 supplementation	No
Secondary	Aortic stiffness	carotid-to-femoral pulse wave velocity	6 months after omega-3 supplementation	No