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Food Frequency Questionnaire to Assess Sodium Intake

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05533645
Acronym
EVALSEL
Enrollment
99
Registered
2022-09-09
Start date
2023-06-06
Completion date
2026-06-30
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Renal Insufficiency

Keywords

natriuresis, Hypertension, Renal insufficiency, Sodium, Table salt

Brief summary

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.

Interventions

OTHERQuestionnaire

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.

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intra-class correlation coefficient between the quantitative measurement of sodium consumption and the 24-hour natriuresis measurement and verification of the 24-hour creatininuria valuesthrough study completion an average of 18 monthsIntra-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.

Countries

France

Contacts

Primary ContactDavid GUYONNET
david.guyonnet@chru-lille.fr0320445962

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026