Metabolic SyndromeNUTRENDNCT02006810
Development of Endothelial Biomarkers
A study testing Induction of endothelial function variations in people with Metabolic Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The main objective is to develop and validate new endothelial function markers discriminating and reproducible by assessing the ability to reveal changes in endothelial function in response to positive and negative nutritional stimuli. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Induction of endothelial function variations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to 19 Sep 2017
- 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 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - 40 to 65 years old
- male
- non-smokers
- Specific inclusion criteria for healthy subjects :
- Healthy subjects should not take antihypertensive or statin.
- Healthy subjects should not present metabolic syndrome but one criterion of the metabolic syndrome will be tolerated.
- Specific inclusion criteria for subjects with metabolic syndrome :
- subjects with metabolic syndrome must have at least 3 of the 5 criteria associated with the metabolic syndrome.
Who cannot join
- treatment vasodilator nitric oxide liberating,
- diabetes and coronary artery disease,
- chronic alcoholism,
- severe hepatic impairment,
- end stage renal failure or dialysis,
- neurological tremor,
Show all 9Show fewer
- cancer, mental illness or other severe disease which can impact informed consent and / or results,
- Refusal to be registered in the National File of Volunteers
- Person in exclusion of the National Volunteer File
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Endothelial Biomarkers for Use in Cohort Studies. Comparison With Reference Biomarkers.
The main objective is to develop and validate new endothelial function markers discriminating and reproducible by assessing the ability to reveal changes in endothelial function in response to positive and negative nutritional stimuli.
Read the detailed description
The study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome).
- Conditions
- Metabolic Syndrome
- Being tested
- Induction of endothelial function variations
- Keywords
- Endothelium biomarkers, Atherosclerotic disease, Endothelial function, Nutritional stimuli
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of endothelial function variationsBehavioural
Also called Improvement with cocoa polyphenol dose, Induction of dysfunction with lipid dose
| Study group | Role | What they receive |
|---|---|---|
| lipids | Experimental | The study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome). Receives: Behavioral: Induction of endothelial function variations |
| flavonoids | Other | The study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome). Receives: Behavioral: Induction of endothelial function variations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Dilatation (FMD)compared to hyperemic velocity time integral (VTI) and endothelial microparticles (MPE)
Changes in endothelial function from baseline at 150 mn after the product intake, evaluated by:
- Flow Mediated Dilatation (FMD) (reference)
Compared to:
- Hyperemic Velocity Time Integral (VTI)
- Endothelial microparticles (MPE)
Measured: at 150 mn after the product intake
Secondary outcomes (1)
Changes in endothelial function evaluated by cell adhesion molecule (CAM) and micro-RNA (miRNA)
Changes in endothelial function from baseline at 150 mn after the product intake, evaluated by:
- Cell Adhesion Molecule (CAM)
- Micro-RNA (miRNA)
Measured: at 150 mn after the product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJul 2013
- Primary completion19 Dec 2016
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas BARBER CHAMOUX, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006810
- Sponsor's protocol ID
- CHU-0168
- Other IDs
- 2013-A00205-40
- Acronym
- NUTREND
- Status last verified
- Sep 2018
- First submitted
- 24 Sep 2013
- Last updated
- 5 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Endothelial Biomarkers for Use in Cohort Studies. Comparison With Reference Biomarkers.
- ClinicalTrials.gov ID
- NCT02006810
- Acronym / sponsor ID
- NUTREND / CHU-0168
- Conditions
- Metabolic Syndrome
- Keywords
- Endothelium biomarkers, Atherosclerotic disease, Endothelial function, Nutritional stimuli
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- 19 Dec 2016 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 10 Dec 2013 (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 main objective is to develop and validate new endothelial function markers discriminating and reproducible by assessing the ability to reveal changes in endothelial function in response to positive and negative nutritional stimuli.
Detailed description
The study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lipids | Experimental | Behavioral: Induction of endothelial function variationsThe study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome). |
| flavonoids | Other | Behavioral: Induction of endothelial function variationsThe study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- - 40 to 65 years old
- male
- non-smokers
- Healthy subjects should not take antihypertensive or statin.
- Healthy subjects should not present metabolic syndrome but one criterion of the metabolic syndrome will be tolerated.
Key exclusion criteria (9 listed)
- treatment vasodilator nitric oxide liberating,
- diabetes and coronary artery disease,
- chronic alcoholism,
- severe hepatic impairment,
- end stage renal failure or dialysis,
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 |
|---|---|---|
| Induction of endothelial function variationsAlso: Improvement with cocoa polyphenol dose, Induction of dysfunction with lipid dose | Behavioural | flavonoids, lipids |
Primary outcome
Flow Mediated Dilatation (FMD)compared to hyperemic velocity time integral (VTI) and endothelial microparticles (MPE)
Time frame: at 150 mn after the product intake
Changes in endothelial function from baseline at 150 mn after the product intake, evaluated by: - Flow Mediated Dilatation (FMD) (reference) Compared to: * Hyperemic Velocity Time Integral (VTI) * Endothelial microparticles (MPE)
1 secondary outcome
Changes in endothelial function evaluated by cell adhesion molecule (CAM) and micro-RNA (miRNA)
Time frame: at 150 mn after the product intake
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 5 Sep 2018.
Related trials for Metabolic Syndrome
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
Nicolas BARBER CHAMOUX principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction of endothelial function variations in people with Metabolic Syndrome, run by University Hospital, Clermont-Ferrand at 1 site 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 8 inclusion and 9 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 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Flow Mediated Dilatation (FMD)compared to hyperemic velocity time integral (VTI) and endothelial microparticles (MPE) (time frame: at 150 mn after the product intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2018.