Impact of Dietary Status on Vascular Function Before and After a Standardized Breakfast. An "Exposed/Unexposed" Study Embedded in the SUVIMAX2 Cohort

Institut National de la Santé Et de la Recherche Médicale, France94 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.