Vascular Impact of Omega-3 in Metabolic Syndrome

NCT ID: NCT01566188

Last Updated: 2014-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-01-31

Brief Summary

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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

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Conditions

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Essential Hypertension Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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omega-3 from vegetal origin

Group Type EXPERIMENTAL

omega-3 from vegetal origin

Intervention Type DIETARY_SUPPLEMENT

6 months of supplementation with omega-3 from vegetal origin

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

6 months of supplementation with placebo

Interventions

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omega-3 from vegetal origin

6 months of supplementation with omega-3 from vegetal origin

Intervention Type DIETARY_SUPPLEMENT

Placebo

6 months of supplementation with placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cyclodextrin/Camelin oil Cyclodextrin/Starch

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robinson Joannides, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Mahes Hospital

Fleury-Mérogis, , France

Site Status

George Pompidou European Hospital

Paris, , France

Site Status

Rouen University Hospital

Rouen, , France

Site Status

Rangueil University Hospital

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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2010/010 HP

Identifier Type: -

Identifier Source: org_study_id

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