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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01579409
First received: April 6, 2012
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
French PNNS Guidelines in Vascular Function
Other: PNNS guidelines
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
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

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Pulse Wave Velocity [ Time Frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates ] [ Designated as safety issue: No ]
    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.

  • Peripheral arterial augmentation index (Aix ) [ Time Frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates ] [ Designated as safety issue: No ]
  • High and low frequency peaks in heart variability spectral analysis [ Time Frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates ] [ Designated as safety issue: No ]
  • High and low frequency peaks in systolic and diastolic blood pressure spectral analysis [ Time Frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates ] [ Designated as safety issue: No ]
  • Mean cutaneous blood flow measured by laser doppler flowmetry [ Time Frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates ] [ Designated as safety issue: No ]
  • Mean cutaneous blood flow measured by laser doppler flowmetry, spectral analysis [ Time Frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates ] [ Designated as safety issue: No ]
  • Percentage of variation of cutaneous blood flow laser doppler measurements after paced breathing (6/min) [ Time Frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates ] [ Designated as safety issue: No ]
  • Increase in cutaneous blood flow laser doppler measurements after acetylcholine iontophoresis [ Time Frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates ] [ Designated as safety issue: No ]
  • Reactive Hyperemia Index after branchial artery occlusion [ Time Frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates ] [ Designated as safety issue: No ]
  • Aortic , radial,digital artery, systolic, diastolic and pulsatile pressures [ Time Frame: During the fasting state, within the hour preceding the standardised breakfast that provides 75 gr of carbohydrates ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of the above mentioned parameters after a standardised breakfast [ Time Frame: After the standardised breakfast that provides 75 gr of carbohydrates, hourly for the next 3 hours following the end of the standardised breakfast ] [ Designated as safety issue: No ]

Estimated Enrollment: 94
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1-25th percentile of the PNNS score Other: PNNS guidelines
Application of PNNS guidelines
75-100th percentile of the PNNS score Other: PNNS guidelines
Application of 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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01579409

Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Paul Valensi, MD CNRH Ile de france
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01579409     History of Changes
Other Study ID Numbers: C11-20, 2011-A01003-38
Study First Received: April 6, 2012
Last Updated: April 16, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Nutrition
Arterial stiffness
Endothelial dysfunction
Microcirculation
Cardiac autonomic system.

ClinicalTrials.gov processed this record on July 10, 2014