Impact of Dietary Status on Vascular Function Before and After a Standardized Breakfast. An "Exposed/Unexposed" Study Embedded in the SUVIMAX2 Cohort

NCT01579409 | Completed Phase 4 DMC

• 2 other identifiers: C11-202011-A01003-38
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

French PNNS Guidelines in Vascular Function

Keywords

Nutrition; Arterial stiffness; Endothelial dysfunction; Microcirculation; Cardiac autonomic system.

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (1)

• 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

Study Arms (2)

1-25th percentile of the PNNS score

OTHER

75-100th percentile of the PNNS score

OTHER

Interventions

PNNS guidelines DRUG

Application of PNNS guidelines

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Hôpital Jean Verdier Service d'Endocrinologie-Diabétologie-Nutrition Avenue du 14 juillet

Bondy, 93149, France

Location

Related Publications (1)

• 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.

  PMID: 31802880 RESULT

Study Officials

• Paul Valensi, MD

  CNRH Ile de france

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: April 18, 2012
• Study Start: November 1, 2011
• Primary Completion: March 4, 2014
• Study Completion: March 4, 2014
• Last Updated: June 5, 2026

Record last verified: 2025-01

Locations

FR (1)