Vascular Impact of Omega-3 in Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Essential Hypertension
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: omega-3 from vegetal origin

• Registration Number: NCT01566188
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-29
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-01
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
omega-3 from vegetal origin	omega-3 from vegetal origin	-

Primary Outcome Measures

Name	Time	Method
Brachial artery flow-mediated dilatation	6 months after omega-3 supplementation

Secondary Outcome Measures

Name	Time	Method
Aortic stiffness	6 months after omega-3 supplementation	carotid-to-femoral pulse wave velocity

Trial Locations

Locations (4)

Rouen University Hospital; 🇫🇷 Rouen, France

George Pompidou European Hospital; 🇫🇷 Paris, France

Mahes Hospital; 🇫🇷 Fleury-Mérogis, France

Rangueil University Hospital; 🇫🇷 Toulouse, France