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CARDIOMEGA: Vascular Impact of Omega-3 in Metabolic Syndrome

Sponsor
University Hospital, Rouen (Other)
Overall Status
Completed
CT.gov ID
NCT01566188
Collaborator
(none)
95
Enrollment
4
Locations
2
Arms
36
Duration (Months)
23.8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Dietary Supplement: omega-3 from vegetal origin
  • Dietary Supplement: Placebo
 N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2011
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

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 Names:
  • Cyclodextrin/Camelin oil

    		•
    Placebo Comparator: Placebo

    Dietary Supplement: Placebo
    6 months of supplementation with placebo
    Other Names:
  • Cyclodextrin/Starch

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Brachial artery flow-mediated dilatation [6 months after omega-3 supplementation]

    Secondary Outcome Measures

    1. Aortic stiffness [6 months after omega-3 supplementation]

      carotid-to-femoral pulse wave velocity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mahes Hospital Fleury-Mérogis France 91700
    2 George Pompidou European Hospital Paris France 75000
    3 Rouen University Hospital Rouen France 76031
    4 Rangueil University Hospital Toulouse France 31059

    Sponsors and Collaborators

    • University Hospital, Rouen

    Investigators

    • Principal Investigator: Robinson Joannides, MD, PhD, Rouen University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Rouen
    ClinicalTrials.gov Identifier:
    NCT01566188
    Other Study ID Numbers:
    • 2010/010 HP
    First Posted:
    Mar 29, 2012
    Last Update Posted:
    Sep 3, 2014
    Last Verified:
    Sep 1, 2014
    Additional relevant MeSH terms:
    Hypertension
    Essential Hypertension
    Metabolic Syndrome
    Syndrome

    Study Results

    No Results Posted as of Sep 3, 2014