Vascular Impact of Omega-3 in Metabolic Syndrome | NCT01566188

Studies
Vascular Impact of Omega-3 in Metabolic Syndrome

NCT01566188

Sponsor

University Hospital, Rouen

Status

Completed

Last Update Posted

Apr 16, 2026Actual

Enrollment

95Actual

Phase

Not Applicable

Conditions

Essential Hypertension
Metabolic Syndrome

Interventions

omega-3 from vegetal origin
Placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Dec 8, 2011

First Submission Date that Met QC Criteria

Mar 26, 2012

First Posted Date

Mar 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2026

Last Update Posted Date

Apr 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
omega-3 from vegetal origin	Experimental		Dietary Supplement: omega-3 from vegetal origin
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
omega-3 from vegetal origin	Dietary Supplement	6 months of supplementation with omega-3 from vegetal origin	omega-3 from vegetal origin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robinson Joannides, MD, PhD	University Hospital, Rouen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mahes Hospital		Fleury-Mérogis		91700	France
George Pompidou European Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34791007	Result	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.

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007333	Insulin Resistance

ID	Term
D003505	Cyclodextrins
D013213	Starch

ID	Term
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D003912	Dextrins
D004040	Dietary Carbohydrates