Essential HypertensionCARDIOMEGANCT01566188
Vascular Impact of Omega-3 in Metabolic Syndrome
A study testing omega-3 from vegetal origin in people with Essential Hypertension and Metabolic Syndrome, run by University Hospital, Rouen at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Essential Hypertension, Metabolic Syndrome
- What is being tested?
- omega-3 from vegetal origin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 4 sitesFrance
- Study dates
- Jan 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Mahes Hospital
Fleury-Mérogis, 91700
George Pompidou European Hospital
Paris, 75000
Rouen University Hospital
Rouen, 76031
Rangueil University Hospital
Toulouse, 31059
About this study
Official title: Cardiovascular Impact of Omega-3 Dietary Supplement From Vegetal Origin in Hypertension Associated With Metabolic Syndrome
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.
- Conditions
- Essential Hypertension, Metabolic Syndrome
- Being tested
- omega-3 from vegetal origin, Placebo
- Medical subject headings
- Essential Hypertension, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 from vegetal originDietary supplement
Also called Cyclodextrin/Camelin oil
6 months of supplementation with omega-3 from vegetal origin
PlaceboDietary supplement
Also called Cyclodextrin/Starch
6 months of supplementation with placebo
| Study group | Role | What they receive |
|---|---|---|
| omega-3 from vegetal origin | Experimental | Not described Receives: Dietary Supplement: omega-3 from vegetal origin |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow-mediated dilatation
Measured: 6 months after omega-3 supplementation
Secondary outcomes (1)
Aortic stiffness
carotid-to-femoral pulse wave velocity
Measured: 6 months after omega-3 supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robinson Joannides, MD, PhD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566188
- Sponsor's protocol ID
- 2010/010 HP
- Acronym
- CARDIOMEGA
- Status last verified
- Sep 2014
- First submitted
- 8 Dec 2011
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Impact of Omega-3 Dietary Supplement From Vegetal Origin in Hypertension Associated With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01566188
- Acronym / sponsor ID
- CARDIOMEGA / 2010/010 HP
- Conditions
- Essential Hypertension, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omega-3 from vegetal origin | Experimental | Dietary Supplement: omega-3 from vegetal origin |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega-3 from vegetal originAlso: Cyclodextrin/Camelin oil6 months of supplementation with omega-3 from vegetal origin | Dietary supplement | omega-3 from vegetal origin |
| PlaceboAlso: Cyclodextrin/Starch6 months of supplementation with placebo | Dietary supplement | Placebo |
Primary outcome
Brachial artery flow-mediated dilatation
Time frame: 6 months after omega-3 supplementation
1 secondary outcome
Aortic stiffness
Time frame: 6 months after omega-3 supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication: PubMed 34791007Bellien 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robinson Joannides, MD, PhD principal investigator
University Hospital, Rouen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega-3 from vegetal origin in people with Essential Hypertension and Metabolic Syndrome, run by University Hospital, Rouen at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial artery flow-mediated dilatation (time frame: 6 months after omega-3 supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01566188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.