Vascular Impact of Omega-3 in Metabolic Syndrome

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01566188

Acronym

CARDIOMEGA

Enrollment

Registered

2012-03-29

Start date

2011-01-01

Completion date

2014-01-01

Last updated

2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension, Metabolic Syndrome

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.

Interventions

DIETARY_SUPPLEMENTomega-3 from vegetal origin

6 months of supplementation with omega-3 from vegetal origin

DIETARY_SUPPLEMENTPlacebo

6 months of supplementation with placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Brachial artery flow-mediated dilatation	6 months after omega-3 supplementation

Secondary

Measure	Time frame	Description
Aortic stiffness	6 months after omega-3 supplementation	carotid-to-femoral pulse wave velocity

Countries

France

Contacts

PRINCIPAL_INVESTIGATORRobinson Joannides, MD, PhD

University Hospital, Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026