Food Frequency Questionnaire to Assess Sodium Intake (EVALSEL)

December 18, 2025 updated by: University Hospital, Lille

Development and Validation of a Food Frequency Questionnaire to Assess Sodium Intake in Hospitalized Patients or in Medical Consultation

EvalSel can precisely assess the salt intake of hospitalized patients in nephrology and cardiology or in medical consultation. It can determine salt consumption to the nearest gram.

The objectives of this food frequency questionnaire are to arrive at a precise dietary diagnosis and to quickly identify the dietary errors made by the patients.

EvalSel is useful for doctors to quickly obtain an assessment of the salt consumption of their patients, so they can refer them to dietitians if necessary. It can be used on the day of admission to hospital or during medical follow-ups to know the evolution of their consumption over the long term and improve their care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France
        • Recruiting
        • Hôpital Huriez - Service Endocrinologie Diabétologie
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with high blood pressure, CKD stages 4-5 and patients free from any diseases
  • Patients over 18 years old
  • Patients in nephrology and cardiology consultation or recruited by CIC
  • Patients with health insurance
  • Patients willing to follow the full study

Exclusion Criteria:

  • Loss of salt by vomiting, diarrhea or sweating (intense sport or intense fever 3 days before urine collection) which can cause a decreasing natriuresis
  • Modification of the therapeutic management of patients during the study period
  • Taking certain drugs like effervescent drugs, Gaviscon and Tolvaptan during the day of urine collection, as well as diuretics (unless they are taken long-term and the diuresis is stable) which can cause an increasing natriuresis
  • Pregnant or breastfeeding women
  • Patients protected by law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
patients with high blood pressure or chronic kidney diseases stages 4-5
Other: Questionnaire
These patients complete the food frequency questionnaire in order to validate it for lower sodium consumptions. The experimental group has already received dietary advices regarding salt consumption during during their recent consultations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-class correlation coefficient between the quantitative measurement of sodium consumption and the 24-hour natriuresis measurement and verification of the 24-hour creatininuria values
Time Frame: through study completion an average of 18 months
Intra-class correlation coefficient between the quantitative measurement of sodium consumption by the EvalSel questionnaire and the 24-hour natriuresis measurement (amount of sodium in 24-hour urine) and verification of the 24-hour creatininuria values (amount of creatinine in 24-hour urine) to confirm that the urine collection was performed correctly.
through study completion an average of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: d GUYONNET, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

September 5, 2022

First Submitted That Met QC Criteria

September 5, 2022

First Posted (Actual)

September 9, 2022

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021_0523
  • 2022-A00241-42 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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