French PNNS Guidelines in Vascular Function Clinical Trial
Official title:
The Impact of the French National Program for Nutrition and Health Guidelines on Vascular Function Following a Standardised Breakfast:The Nutri-Vasc Study
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.
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.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening