Clinical trial NCT01579409: Impact of Dietary Status on Vascular Function Before and After a Standardized Breakfast. an "exposed/unexposed" Study Embedded in the SUVIMAX2 Cohort
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: French PNNS Guidelines in Vascular Function
Keywords: Nutrition
Arterial stiffness
Endothelial dysfunction
Microcirculation
Cardiac autonomic system.
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2012-04-18
Enrollment: 94
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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, 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pulse Wave Velocity
timeFrame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
measure: Peripheral arterial augmentation index (Aix )
timeFrame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
measure: High and low frequency peaks in heart variability spectral analysis
timeFrame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
measure: High and low frequency peaks in systolic and diastolic blood pressure spectral analysis
timeFrame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
measure: Mean cutaneous blood flow measured by laser doppler flowmetry
timeFrame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
measure: Mean cutaneous blood flow measured by laser doppler flowmetry, spectral analysis
timeFrame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
measure: Percentage of variation of cutaneous blood flow laser doppler measurements after paced breathing (6/min)
timeFrame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
measure: Increase in cutaneous blood flow laser doppler measurements after acetylcholine iontophoresis
timeFrame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
measure: Reactive Hyperemia Index after branchial artery occlusion
timeFrame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
measure: Aortic , radial,digital artery, systolic, diastolic and pulsatile pressures
timeFrame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Secondary outcomes:
measure: Comparison of the above mentioned parameters after a standardised breakfast
timeFrame: After the standardised breakfast that provides 75 gr of carbohydrates, hourly for the next 3 hours following the end of the standardised breakfast
Other outcomes:
Locations:
Study officials:
affiliation: CNRH Ile de france
name: Paul Valensi, MD
role: STUDY_DIRECTOR
References:
citation: 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.