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

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.

Study Overview

• Status: Unknown
• Conditions: French PNNS Guidelines in Vascular Function
• Intervention / Treatment: Other: PNNS guidelines

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1-25th percentile of the PNNS score	Other: PNNS guidelines; Application of PNNS guidelines
Other: 75-100th percentile of the PNNS score	Other: PNNS guidelines; Application of PNNS guidelines

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Study Director: Paul Valensi, MD, CNRH Ile de france

Publications and helpful links

General Publications

• Fysekidis M, Kesse-Guyot E, Valensi P, Arnault N, Galan P, Hercberg S, Cosson E. Association Between Adherence To The French Dietary Guidelines And Lower Resting Heart Rate, Longer Diastole Duration, And Lower Myocardial Oxygen Consumption. The NUTRIVASC Study. Vasc Health Risk Manag. 2019 Oct 30;15:463-475. doi: 10.2147/VHRM.S215795. eCollection 2019.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: April 6, 2012
• First Submitted That Met QC Criteria: April 16, 2012
• First Posted (Estimate): April 18, 2012

Study Record Updates

• Last Update Posted (Estimate): April 18, 2012
• Last Update Submitted That Met QC Criteria: April 16, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Endothelial dysfunction; Nutrition; Arterial stiffness; Microcirculation; Cardiac autonomic system.
• Other Study ID Numbers: C11-20; 2011-A01003-38 (Registry Identifier: IDRCB)