Hôpital Jean Verdier Service d'Endocrinologie-Diabétologie-Nutrition Avenue du 14 juillet
Bondy, 93149, France
NCT Number: NCT01579409
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.
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Notify Me50 year–75 year
All sexes
Interventional
Phase 4
Bondy, 93149, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Application of PNNS guidelines
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.
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
Time frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates
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
Institut National de la Santé Et de la Recherche Médicale, France
Other Gov
" 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
Acronym: Nutri-MicroVas
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