EvalSel food-frequency questionnaire to measure daily salt intake
Development and Validation of a Food Frequency Questionnaire to Assess Sodium Intake in Hospitalized Patients or in Medical Consultation
This will test whether the EvalSel food-frequency questionnaire can precisely measure daily salt intake in adults with hypertension, stage 4–5 chronic kidney disease, or without disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT05533645 on ClinicalTrials.gov |
What this trial studies
The EvalSel intervention uses a structured food-frequency questionnaire administered to hospitalized patients or those attending nephrology and cardiology consultations to estimate salt intake to the nearest gram. Participants complete the questionnaire at admission or during follow-up to produce a rapid dietary diagnosis and to identify common dietary errors. The protocol excludes patients with recent large salt losses, recent therapeutic changes, or use of drugs that alter natriuresis, and it enrolls adults over 18 with hypertension, CKD stages 4–5, or healthy controls who have health insurance. The tool is intended to help clinicians refer patients to dietitians and to track salt consumption over time to improve care.
Who should consider this trial
Good fit: Adults (≥18) with hypertension or CKD stages 4–5, or adults without disease, seen in nephrology or cardiology consultations (or recruited by the coordinating center), with health insurance and willing to follow the protocol are ideal candidates.
Not a fit: Patients with recent vomiting, diarrhea, intense sweating, recent medication changes, use of interfering medications (e.g., certain effervescent drugs or diuretics unless stable), pregnant or breastfeeding women, and legally protected individuals may not benefit or are excluded.
Why it matters
Potential benefit: If successful, EvalSel could let clinicians rapidly identify high salt intake so patients can get timely dietitian referral and tailored advice to help lower blood pressure and protect kidney function.
How similar studies have performed: Similar food-frequency questionnaires and brief dietary tools have been used and often correlate moderately with urinary sodium measurements, but gram-level precision is not consistently demonstrated in prior work.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lille
- Hôpital Huriez - Service Endocrinologie Diabétologie — Lille, France (Recruiting)
Study contacts
- Principal investigator: d GUYONNET — University Hospital, Lille
- Study coordinator: David GUYONNET
- Email: david.guyonnet@chru-lille.fr
- Phone: 0320445962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.