Impact of Dietary Status on Vascular Function Before and After a Standardized Breakfast. an "exposed/unexposed" Study Embedded in the SUVIMAX2 Cohort (Nutri-MicroVas)

Institut National de la Santé Et de la Recherche Médicale, France

Status and phase: Completed; Phase 4

Conditions: French PNNS Guidelines in Vascular Function

Treatments: Other: PNNS guidelines

Study type: Interventional

Funder types: Other

Identifiers

NCT01579409

2011-A01003-38 (Registry Identifier)

C11-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

1-25th percentile of the PNNS score

Other group

Treatment:

Other: PNNS guidelines

75-100th percentile of the PNNS score

Other group

Treatment:

Other: PNNS guidelines