The Impact of the French PNNS Guidelines on Vascular Function Following a Standardised Breakfast.

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of the French National Program for Nutrition and Health Guidelines on Vascular Function Following a Standardised Breakfast:The Nutri-Vasc Study

Conditions
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French PNNS Guidelines in Vascular Function

Intervention / Treatment
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* Other: PNNS guidelines


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1-25th percentile of the PNNS score<br> | Other: PNNS guidelines<br>* Application of PNNS guidelines<br>|
| Other: 75-100th percentile of the PNNS score<br> | Other: PNNS guidelines<br>* Application of PNNS guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates | 
| Peripheral arterial augmentation index (Aix ) |  | During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates | 
| High and low frequency peaks in heart variability spectral analysis |  | During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates | 
| High and low frequency peaks in systolic and diastolic blood pressure spectral analysis |  | During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates | 
| Mean cutaneous blood flow measured by laser doppler flowmetry |  | During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates | 
| Mean cutaneous blood flow measured by laser doppler flowmetry, spectral analysis |  | During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates | 
| Percentage of variation of cutaneous blood flow laser doppler measurements after paced breathing (6/min) |  | During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates | 
| Increase in cutaneous blood flow laser doppler measurements after acetylcholine iontophoresis |  | During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates | 
| Reactive Hyperemia Index after branchial artery occlusion |  | During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates | 
| Aortic , radial,digital artery, systolic, diastolic and pulsatile pressures |  | During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the above mentioned parameters after a standardised breakfast |  | After the standardised breakfast that provides 75 gr of carbohydrates, hourly for the next 3 hours following the end of the standardised breakfast | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Arterial stiffness, Endothelial dysfunction, Microcirculation, Cardiac autonomic system.