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

French PNNS Guidelines in Vascular Function Clinical Trial

— NUTRIVASC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01579409
• Other study ID #: C11-20
• Secondary ID: 2011-A01003-38
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: April 6, 2012
• Last updated: April 16, 2012
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 94
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• French PNNS Guidelines in Vascular Function

Intervention

Other:
• PNNS guidelines
Application of PNNS guidelines

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Peripheral arterial augmentation index (Aix )		During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Reactive Hyperemia Index after branchial artery occlusion		During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates	No
Primary	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	No
Secondary	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	No