NCT01566188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 16, 2026

Status Verified

September 1, 2014

Enrollment Period

3 years

First QC Date

December 8, 2011

Last Update Submit

April 13, 2026

Conditions

Essential HypertensionMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Brachial artery flow-mediated dilatation

    6 months after omega-3 supplementation

Secondary Outcomes (1)

  • Aortic stiffness

    6 months after omega-3 supplementation

Study Arms (2)

omega-3 from vegetal origin

EXPERIMENTAL
Dietary Supplement: omega-3 from vegetal origin

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

omega-3 from vegetal originDIETARY_SUPPLEMENT

6 months of supplementation with omega-3 from vegetal origin

Also known as: Cyclodextrin/Camelin oil
omega-3 from vegetal origin
PlaceboDIETARY_SUPPLEMENT

6 months of supplementation with placebo

Also known as: Cyclodextrin/Starch
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mahes Hospital

Fleury-Mérogis, 91700, France

Location

George Pompidou European Hospital

Paris, 75000, France

Location

Rouen University Hospital

Rouen, 76031, France

Location

Rangueil University Hospital

Toulouse, 31059, France

Location

Related Publications (1)

  • 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.

    PMID: 34791007RESULT

MeSH Terms

Conditions

Essential HypertensionMetabolic Syndrome

Interventions

CyclodextrinsStarch

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Macrocyclic CompoundsPolycyclic CompoundsDextrinsDietary CarbohydratesCarbohydratesGlucansPolysaccharidesBiopolymersPolymersMacromolecular Substances

Study Officials

  • Robinson Joannides, MD, PhD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2011

First Posted

March 29, 2012

Study Start

January 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 16, 2026

Record last verified: 2014-09

Locations

FR(4)