French PNNS Guidelines in Vascular FunctionPhase 4Nutri-MicroVasNCT01579409
Impact of Dietary Status on Vascular Function Before and After a Standardized Breakfast. An "Exposed/Unexposed" Study Embedded in the SUVIMAX2 Cohort
A Phase 4 study testing PNNS guidelines in people with French PNNS Guidelines in Vascular Function, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
In France, primary cardiovascular and metabolic prevention is supported by the French National Program for Nutrition and Health (PNNS: Programme National Nutrition Santé). The investigators made the hypothesis that, independently of other diseases, the non adherence in PNNS guidelines would lead to arterial stiffness… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- French PNNS Guidelines in Vascular Function
- What is being tested?
- PNNS guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to 4 Mar 2014
- Phase
- Phase 4
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Social Security affiliation.
- Participation in SU.VI.MAX 2.
- Subjects without legal guardian who can freely agree to participate to the study.
- PNNS score in 2012 lower (cases) or upper (controls) quartile.
Who cannot join
- Known diabetes or prediabetes before the inclusion.
- History of cardiovascular disease.
- Treatment for hypertension.
- Treatment for dyslipidemia.
- Known Cancer
- Smoking or patients that have stopped smoking less than 3 years
- Cardiac pacemaker
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Jean Verdier Service d'Endocrinologie-Diabétologie-Nutrition Avenue du 14 juillet
Bondy, 93149
About this study
Official title: " Impact du Statut Alimentaire Sur la Fonction Vasculaire Avant et après un Petit-déjeuner standardisé. Une étude " exposé/Non exposé " nichée Dans la Cohorte SUVIMAX2
In France, primary cardiovascular and metabolic prevention is supported by the French National Program for Nutrition and Health (PNNS: Programme National Nutrition Santé).
The investigators made the hypothesis that, independently of other diseases, the non adherence in PNNS guidelines would lead to arterial stiffness, endothelial dysfunction, change in microcirculation and in cardiac autonomic system. These changes may exist at fasting but also be reinforced after a standardised breakfast.
The investigators aim is to evaluate arterial stiffness, endothelial function, microcirculation and cardiac autonomic system according to PNNS status in a case control study.
Read the detailed description
This is a case / control pilot nested in SU.VI.MAX 2 (SUpplémentation en VItamines et Minéraux Anti-oXydants) study. The randomized longitudinal placebo controlled SU.VI.MAX study tested the preventive effect of vitamin and antioxidant minerals supplementation on the incidence and the mortality from cardiovascular pathologies and cancers. SU.VI.MAX 2 was the extension of the previous study and included 7200 subjects for whom food habits were known and characterized according to PNNS guidelines (PNNS score).
The subjects will be pre-selected from the original cohort SU.VI.MAX2 if they have a PNNS score in 2007 in the 1-40th or 60-100th percentiles of distribution. If they accept to participate, a new PNNS score will be calculated in 2012-2013 and the subjects in the 1-25th or 75-100th percentiles will be included and explored during one day of participation.
Our aim is to evaluate arterial stiffness, endothelial function, microcirculation and cardiac autonomic system according to PNNS status in a case control study.
Our secondary objective is to evaluate the same parameters in the same subjects but after a breakfast containing 75 g glucose.
- Being tested
- PNNS guidelines
- Keywords
- Nutrition, Arterial stiffness, Endothelial dysfunction, Microcirculation, Cardiac autonomic system.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNNS guidelinesDrug
Application of PNNS guidelines
| Study group | Role | What they receive |
|---|---|---|
| 1-25th percentile of the PNNS score | Other | Not described |
| 75-100th percentile of the PNNS score | Other | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Wave Velocity
This is a pilot study. Pulse wave velocity, an index of arterial stiffness, was chosen as the primary endpoint. A total of 47 subjects in each group was necessary to detect a difference between groups of 1m/s in pulse wave velocity (standard deviation of 1.7 m/s) with a statistical power of 80%, at fasting.
Measured: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Peripheral arterial augmentation index (Aix )
Measured: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
High and low frequency peaks in heart variability spectral analysis
Measured: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
High and low frequency peaks in systolic and diastolic blood pressure spectral analysis
Measured: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Mean cutaneous blood flow measured by laser doppler flowmetry
Measured: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Mean cutaneous blood flow measured by laser doppler flowmetry, spectral analysis
Measured: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Percentage of variation of cutaneous blood flow laser doppler measurements after paced breathing (6/min)
Measured: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Increase in cutaneous blood flow laser doppler measurements after acetylcholine iontophoresis
Measured: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Reactive Hyperemia Index after branchial artery occlusion
Measured: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Aortic , radial,digital artery, systolic, diastolic and pulsatile pressures
Measured: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Secondary outcomes (1)
Comparison of the above mentioned parameters after a standardised breakfast
Measured: After the standardised breakfast that provides 75 gr of carbohydrates, hourly for the next 3 hours following the end of the standardised breakfast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startNov 2011
- Primary completion4 Mar 2014
- Study completion4 Mar 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 French PNNS Guidelines in Vascular FunctionStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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 4
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Paul Valensi, MD, Study director, CNRH Ile de france
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579409
- Sponsor's protocol ID
- C11-20
- Other IDs
- 2011-A01003-38
- Acronym
- Nutri-MicroVas
- Status last verified
- Jan 2025
- First submitted
- 6 Apr 2012
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fysekidis M, Kesse-Guyot E, Valensi P, Arnault N, Galan P, Hercberg S, Cosson E. Association Between Adherence To The French Dietary Guidelines And Lower Resting Heart Rate, Longer Diastole Duration, And Lower Myocardial Oxygen Consumption. The NUTRIVASC Study. Vasc Health Risk Manag. 2019 Oct 30;15:463-475. doi: 10.2147/VHRM.S215795. eCollection 2019.
PubMed 31802880
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " Impact du Statut Alimentaire Sur la Fonction Vasculaire Avant et après un Petit-déjeuner standardisé. Une étude " exposé/Non exposé " nichée Dans la Cohorte SUVIMAX2
- ClinicalTrials.gov ID
- NCT01579409
- Acronym / sponsor ID
- Nutri-MicroVas / C11-20
- Keywords
- Nutrition, Arterial stiffness, Endothelial dysfunction, Microcirculation, Cardiac autonomic system.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Nov 2011 (actual)
- Primary completion
- 4 Mar 2014 (actual)
- Study completion
- 4 Mar 2014 (actual)
- First posted
- 18 Apr 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.
In France, primary cardiovascular and metabolic prevention is supported by the French National Program for Nutrition and Health (PNNS: Programme National Nutrition Santé).
The investigators made the hypothesis that, independently of other diseases, the non adherence in PNNS guidelines would lead to arterial stiffness, endothelial dysfunction, change in microcirculation and in cardiac autonomic system. These changes may exist at fasting but also be reinforced after a standardised breakfast.
The investigators aim is to evaluate arterial stiffness, endothelial function, microcirculation and cardiac autonomic system according to PNNS status in a case control study.
Detailed description
This is a case / control pilot nested in SU.VI.MAX 2 (SUpplémentation en VItamines et Minéraux Anti-oXydants) study. The randomized longitudinal placebo controlled SU.VI.MAX study tested the preventive effect of vitamin and antioxidant minerals supplementation on the incidence and the mortality from cardiovascular pathologies and cancers. SU.VI.MAX 2 was the extension of the previous study and included 7200 subjects for whom food habits were known and characterized according to PNNS guidelines (PNNS score).
The subjects will be pre-selected from the original cohort SU.VI.MAX2 if they have a PNNS score in 2007 in the 1-40th or 60-100th percentiles of distribution. If they accept to participate, a new PNNS score will be calculated in 2012-2013 and the subjects in the 1-25th or 75-100th percentiles will be included and explored during one day of participation.
Our aim is to evaluate arterial stiffness, endothelial function, microcirculation and cardiac autonomic system according to PNNS status in a case control study.
Our secondary objective is to evaluate the same parameters in the same subjects but after a breakfast containing 75 g glucose.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-25th percentile of the PNNS score | Other | – |
| 75-100th percentile of the PNNS score | Other | – |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Social Security affiliation.
- Participation in SU.VI.MAX 2.
- Subjects without legal guardian who can freely agree to participate to the study.
- PNNS score in 2012 lower (cases) or upper (controls) quartile.
Key exclusion criteria (7 listed)
- Known diabetes or prediabetes before the inclusion.
- History of cardiovascular disease.
- Treatment for hypertension.
- Treatment for dyslipidemia.
- Known Cancer
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 |
|---|---|---|
| PNNS guidelinesApplication of PNNS guidelines | Drug | – |
Primary outcome
Pulse Wave Velocity
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
This is a pilot study. Pulse wave velocity, an index of arterial stiffness, was chosen as the primary endpoint. A total of 47 subjects in each group was necessary to detect a difference between groups of 1m/s in pulse wave velocity (standard deviation of 1.7 m/s) with a statistical power of 80%, at fasting.
Peripheral arterial augmentation index (Aix )
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
High and low frequency peaks in heart variability spectral analysis
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
High and low frequency peaks in systolic and diastolic blood pressure spectral analysis
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Mean cutaneous blood flow measured by laser doppler flowmetry
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Mean cutaneous blood flow measured by laser doppler flowmetry, spectral analysis
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Percentage of variation of cutaneous blood flow laser doppler measurements after paced breathing (6/min)
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Increase in cutaneous blood flow laser doppler measurements after acetylcholine iontophoresis
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Reactive Hyperemia Index after branchial artery occlusion
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Aortic , radial,digital artery, systolic, diastolic and pulsatile pressures
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
1 secondary outcome
Comparison of the above mentioned parameters after a standardised breakfast
Time frame: After the standardised breakfast that provides 75 gr of carbohydrates, hourly for the next 3 hours following the end of the standardised breakfast
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 Jun 2026.
- Results publication: PubMed 31802880Fysekidis M, Kesse-Guyot E, Valensi P, Arnault N, Galan P, Hercberg S, Cosson E. Association Between Adherence To The French Dietary Guidelines And Lower Resting Heart Rate, Longer Diastole Duration, And Lower Myocardial Oxygen Consumption. The NUTRIVASC Study. Vasc Health Risk Manag. 2019 Oct 30;15:463-475. doi: 10.2147/VHRM.S215795. eCollection 2019.
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.
Paul Valensi, MD study director
CNRH Ile de france
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PNNS guidelines in people with French PNNS Guidelines in Vascular Function, run by Institut National de la Santé Et de la Recherche Médicale, France 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 4 inclusion and 7 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 Jun 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pulse Wave Velocity (time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates). The study lists 10 primary outcomes in all. 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 NCT01579409, 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 5 Jun 2026.