Actively Recruiting
Assessment of Protein Intake Using 2 Types of Nutritional Collection Compared with 24-hour Urine Urea in Chronic Kidney Disease
Led by Assistance Publique Hopitaux De Marseille · Updated on 2024-11-19
60
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic kidney disease (CKD) affects about 10% of the population in France, with stages ranging from 1 to 5, where stage 5 requires treatments like dialysis or kidney transplantation. In advanced stages 4 and 5, a low-protein diet may delay the need for dialysis. This research evaluates how well two dietary assessment methods—a detailed 3-day dietary record and a Food Frequency Questionnaire (FFQ) via a web app—match with the gold standard of 24-hour urine urea measurement to assess protein intake in people with CKD. Participants will provide protein intake information through the 3-day dietary record and the FFQ questionnaire twice during the study: once at the initial dietary consultation and again 6 months later. The FFQ is designed for patients to use on their own via the web app, while the 3-day dietary record is the conventional method. The study compares these dietary tools with the 24-hour urine urea test to see which aligns best with actual protein intake. Participants will be involved in regular dietary consultations where their protein intake will be assessed using the two methods and compared with urine tests. The study will also measure the time dieticians spend collecting data with each method at the start and after 6 months. The main outcome is how well the dietary assessments agree with the urine urea results within one month and again six months later. This study runs through July 2028 and aims to improve dietary management in CKD.
CONDITIONS
Brief Title
Assessment of Protein Intake Using 2 Types of Nutritional Collection in Chronic Kidney Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient at least 18 years of age
- Patient capable of understanding the study and giving informed non-opposition
- Patient with stage 4 or 5 chronic kidney disease
- Patient included in the MRC pathway
- Patient motivated to follow a low-protein diet
- Patient able to use a computer, smartphone, or tablet with internet access
You will not qualify if you...
- Difficulty reading or understanding the French language
- Patient with ongoing cancer
- Patient undernourished or at risk of undernutrition based on recent weight loss and albumin levels
- Persons covered by French Public Health Code articles L. 1121-5 to L. 1121-8, including minors, adults under guardianship, patients deprived of liberty, pregnant or breastfeeding women
- Dialysis patients
- Patients who had major surgery within the last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Between 6 and 7 months
Participants provide dietary information using a 3-day dietary record and a Food Frequency Questionnaire at the initial dietary consultation and 6 months later to assess protein intake.
2 visits (in-person) at initial consultation and 6 months follow-up
Trial Site Locations
Total: 1 location
1
Centre de néphrologie et de transplantation rénale
Marseille, France, France, 13005
Actively Recruiting
Research Team
V
Valérie PRUDHOMME, Dietician
L
Lysa HAZAN, Dietician
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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