Assessing protein intake methods in patients with chronic kidney disease.
Assessment of Protein Intake Using 2 Types of Nutritional Collection in Comparison with 24-hour Urine Urea, in Chronic Kidney Disease.
This study is testing two ways to track protein intake in people with advanced chronic kidney disease to see which method helps them follow a low-protein diet better and delay the need for dialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille, France) |
| Trial ID | NCT06224153 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates two methods for assessing protein intake in patients with chronic kidney disease (CKD) stages 4 and 5. The study compares the traditional 24-hour urine urea measurement with a detailed 3-day dietary record and Food Frequency Questionnaire (FFQ) to determine the most effective approach for introducing a low-protein diet. The goal is to better understand dietary habits and facilitate dietary modifications to delay the need for dialysis. Conducted in the PACA region of France, the study aims to improve dietary management for CKD patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stage 4 or 5 chronic kidney disease who are motivated to follow a hypo-protein diet.
Not a fit: Patients currently undergoing dialysis or those with ongoing cancer or significant undernutrition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance dietary management strategies for CKD patients, potentially delaying the need for dialysis.
How similar studies have performed: While the approach of assessing dietary intake is common, this specific comparison of methods in CKD patients is less explored, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient at least 18 years of age, * Patient capable of understanding the study and having given informed non-opposition, * Patient with stage 4 or 5 CKD, * Patient included in the MRC pathway, * Patient motivated by a hypo-protein diet, * Patient able to use a computer/smartphone/tablet with Internet access. Exclusion Criteria: * Difficulty reading or understanding the French language, * Patient with ongoing cancer, * Patient undernourished or at risk of undernutrition (based on weight loss and albumin measurement from last blood test), * Persons covered by articles L. 1121-5 to L. 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women). * Dialysis patient * Patient who underwent major surgery less than 3 months ago.
Where this trial is running
Marseille, France
- Centre de néphrologie et de transplantation rénale — Marseille, France, France (Recruiting)
Study contacts
- Study coordinator: Valérie PRUDHOMME, Dietician
- Email: valerie.prudhomme@ap-hm.fr
- Phone: 0491483092
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.