Impact of Dietary Status on Vascular Function Before and After a Standardized Breakfast. an "exposed/unexposed" Study Embedded in the SUVIMAX2 Cohort

NCT ID: NCT01579409

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-03-04

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.

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.

Conditions

French PNNS Guidelines in Vascular Function

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

1-25th percentile of the PNNS score

Group Type: OTHER

PNNS guidelines

Intervention Type: OTHER

Application of PNNS guidelines

75-100th percentile of the PNNS score

Group Type: OTHER

PNNS guidelines

Intervention Type: OTHER

Application of PNNS guidelines

Interventions

PNNS guidelines

Application of PNNS guidelines

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Valensi, MD

Role: STUDY_DIRECTOR

CNRH Ile de france

References

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.

Reference Type: DERIVED

PMID: 31802880 (View on PubMed)

Other Identifiers

C11-20

Identifier Type: -

Identifier Source: org_study_id

2011-A01003-38

Identifier Type: REGISTRY

Identifier Source: secondary_id