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CompletedNCT01566188CARDIOMEGAUpdated Apr 16, 2026

Vascular Impact of Omega-3 in Metabolic Syndrome

An interventional study of omega-3 from vegetal origin and Placebo in Essential Hypertension and Metabolic Syndrome, sponsored by University Hospital, Rouen. Completed at 4 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
95
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Essential Hypertension
  • Metabolic Syndrome
03

In context

Essential Hypertension

527 studies on the registry are indexed under Essential Hypertension; 76 are open to participants now.

This study's enrollment of 95 is below the median of 166 across 449 interventional studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
95 participants (actual)

Study arms

  • Experimental
    omega-3 from vegetal origin

    Dietary Supplement: omega-3 from vegetal origin

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementomega-3 from vegetal origin

    6 months of supplementation with omega-3 from vegetal origin

    Also known as: Cyclodextrin/Camelin oil

  • Dietary supplementPlacebo

    6 months of supplementation with placebo

    Also known as: Cyclodextrin/Starch

06

What researchers measure

Primary outcomes

  1. Brachial artery flow-mediated dilatation

    Time frame: 6 months after omega-3 supplementation

Secondary outcomes

  1. Aortic stiffness

    carotid-to-femoral pulse wave velocity

    Time frame: 6 months after omega-3 supplementation

07

Study locations

4 sites
  • Mahes Hospital
    Fleury-Mérogis, 91700, France
  • George Pompidou European Hospital
    Paris, 75000, France
  • Rouen University Hospital
    Rouen, 76031, France
  • Rangueil University Hospital
    Toulouse, 31059, France
08

References and documents

Publications

  • Bellien J, Bozec E, Bounoure F, Khettab H, Malloizel-Delaunay J, Skiba M, Iacob M, Donnadieu N, Coquard A, Morio B, Laillet B, Rigaudiere JP, Chardigny JM, Monteil C, Vendeville C, Mercier A, Cailleux AF, Blanchard A, Amar J, Fezeu LK, Pannier B, Bura-Riviere A, Boutouyrie P, Joannides R. The effect of camelina oil on vascular function in essential hypertensive patients with metabolic syndrome: a randomized, placebo-controlled, double-blind study. Am J Clin Nutr. 2022 Mar 4;115(3):694-704. doi: 10.1093/ajcn/nqab374. PubMed 34791007 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01566188
Lead sponsor
University Hospital, Rouen
Responsible party
Sponsor
First posted
Mar 29, 2012
Start date
Jan 2011
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Apr 16, 2026

Study contacts

Robinson Joannides, MD, PhD
principal investigator · University Hospital, Rouen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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