Chronic Kidney Disease (stages 4 and 5)APRONUT_MRCNCT06224153
Assessment of Protein Intake Using 2 Types of Nutritional Collection in Chronic Kidney Disease.
An observational study of Chronic Kidney Disease (stages 4 and 5), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
In France, 10% of the population suffers from chronic kidney disease (CKD). CKD is classified into five stages, described from the least severe (stage 1) to the most severe (stage 5). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (stages 4 and 5)
- What is being tested?
- 3-day dietary record and Food Frequency Questionnaire (FFQ)
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2024to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic kidney disease at stage 4 ou 5
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre de néphrologie et de transplantation rénale
Marseille, France, 13005
Valérie PRUDHOMME, Dietician, 0491483092 ext. 33, valérie.prudhomme@ap-hm.fr
About this study
Official title: Assessment of Protein Intake Using 2 Types of Nutritional Collection in Comparison with 24-hour Urine Urea, in Chronic Kidney Disease.
In France, 10% of the population suffers from chronic kidney disease (CKD). CKD is classified into five stages, described from the least severe (stage 1) to the most severe (stage 5). Every year, in the PACA region, around 1,000 new patients present with end-stage CKD (5D), necessitating the introduction of suppletive therapy, whether hemodialysis, peritoneal dialysis or kidney transplantation. In CKD stages 4 and 5, a hypo-protein diet can be proposed to delay dialysis initiation (Garneata et al. 2016).
To introduce a low-protein diet, the dietician first assesses protein intake. This can be done by :
Read more
- Measuring 24-hour urine urea. This is the reference method for assessing the amount of protein consumed over the last 24 hours. However, it cannot be used to determine the patient's dietary habits, and therefore cannot be used to suggest modifications with a view to introducing a low-protein diet.
- A detailed dietary record. The 3-day dietary record currently in use (a tool for recording dietary habits defined by the HAS) provides a reliable assessment of protein intake. However, this tool takes up a lot of dietetic time, limiting the time available for nutrition education and the number of patients who can benefit from a dietetic consultation.
MS-Nutrition is a start-up that has developed a web application that can be used by patients themselves to assess nutritional intakes, incorporating a food frequency questionnaire (known as the FFQ questionnaire) used to obtain information on the frequency of foods and drinks consumed over a period of time (1 week, 1 month...).
For the general population (without CKD), there is good agreement between the FFQ questionnaire and a conventional ingesta assessment (3-day dietary record as currently practiced or 24h recall, another collection based on the previous day's consumption) (Affret et al., 2018; Deschamps et al., 2009). These studies on healthy adults do not take into account the reference method (urinary urea) for assessing protein intake.
Only one study in the CKD population evaluates the concordance of the assessment of protein intakes (as well as calcium, phosphorus, potassium and sodium intakes) between an FFQ questionnaire and a dietary record (24-hour recall) (Affret et al. 2017). This study shows an acceptable correlation between the FFQ and the dietary record (correlation coefficient between 0.05 and 0.79, with a median of 0.40), yet this study was carried out without dietary intervention and using a different type of dietary record. As in studies on a population of healthy adults, protein intakes assessed by any type of dietary questionnaire are not compared with a more reliable assessment of these same intakes (24-hour urine urea).
The proposed study will compare the concordance of dietary intake assessment between each of the 2 types of dietary collection (FFQ and a 3-day dietary collection) and 24-hour urine urea, which limits the biases inherent in dietary collection.
- Conditions
- Chronic Kidney Disease (stages 4 and 5)
- Being tested
- 3-day dietary record, Food Frequency Questionnaire (FFQ)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-day dietary recordOther
This is the conventional ingesta assessment. It will be performed twice during the study.
Food Frequency Questionnaire (FFQ)Other
This questionnaire is used to obtain information on the frequency of foods and drinks consumed over a period of time (1 week, 1 month...). It will be performed twice during the study.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic kidney disease | Not described Receives: Other: 3-day dietary record; Other: Food Frequency Questionnaire (FFQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the concordance between the reference method (24-hour urinary urea) and : (1) protein intake estimated by the 3-day dietary record ; (2) protein intakes estimated by FFQ via web application at the initial dietary consultation.
Measured: Between 15 days and 1 month
Secondary outcomes (6)
Assessment of concordance between protein intake estimated by the 3-day dietary record and 24-hour urine urea measurement 6 months after the initial dietary consultation
Measured: Between 6 and 7 months
Assessment of concordance between protein intakes estimated by FFQ via web application and 24-hour urine urea measurement 6 months after the initial dietary consultation
Measured: Between 6 and 7 months
Evaluation and comparison of the time taken by the dietician to collect the data required to assess protein intake with the 2 types of dietary record at the initial dietary consultation
Measured: Between 15 days and 1 month
Evaluation and comparison of the time taken by the dietician to collect the data required to assess protein intake with the 2 types of dietary record 6 months after the initial dietary consultation
Measured: Between 6 and 7 months
Assessment of the concordance between nutritional intakes obtained by the 2 food collection methods at the initial dietary consultation
Measured: Between 15 days and 1 month
Assessment of the concordance between nutritional intakes obtained by the 2 food collection methods 6 months after the initial dietary consultation
Measured: Between 6 and 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start15 Nov 2024
- Primary completion15 Dec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (stages 4 and 5)Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224153
- Sponsor's protocol ID
- RCAPHM22_0201
- Other IDs
- ID-RCB
- Acronym
- APRONUT_MRC
- Status last verified
- Nov 2024
- First submitted
- 16 Jan 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Protein Intake Using 2 Types of Nutritional Collection in Comparison with 24-hour Urine Urea, in Chronic Kidney Disease.
- ClinicalTrials.gov ID
- NCT06224153
- Acronym / sponsor ID
- APRONUT_MRC / RCAPHM22_0201
- Conditions
- Chronic Kidney Disease (stages 4 and 5)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In France, 10% of the population suffers from chronic kidney disease (CKD). CKD is classified into five stages, described from the least severe (stage 1) to the most severe (stage 5). Every year, in the PACA region, around 1,000 new patients present with end-stage CKD (5D), necessitating the introduction of suppletive therapy, whether hemodialysis, peritoneal dialysis or kidney transplantation. In CKD stages 4 and 5, a hypo-protein diet can be proposed to delay dialysis initiation (Garneata et al. 2016).
To introduce a low-protein diet, the dietician first assesses protein intake. This can be done by :
- Measuring 24-hour urine urea. This is the reference method for assessing the amount of protein consumed over the last 24 hours. However, it cannot be used to determine the patient's dietary habits, and therefore cannot be used to suggest modifications with a view to introducing a low-protein diet.
- A detailed dietary record. The 3-day dietary record currently in use (a tool for recording dietary habits defined by the HAS) provides a reliable assessment of protein intake. However, this tool takes up a lot of dietetic time, limiting the time available for nutrition education and the number of patients who can benefit from a dietetic consultation.
MS-Nutrition is a start-up that has developed a web application that can be used by patients themselves to assess nutritional intakes, incorporating a food frequency questionnaire (known as the FFQ questionnaire) used to obtain information on the frequency of foods and drinks consumed over a period of time (1 week, 1 month...).
For the general population (without CKD), there is good agreement between the FFQ questionnaire and a conventional ingesta assessment (3-day dietary record as currently practiced or 24h recall, another collection based on the previous day's consumption) (Affret et al., 2018; Deschamps et al., 2009). These studies on healthy adults do not take into account the reference method (urinary urea) for assessing protein intake.
Only one study in the CKD population evaluates the concordance of the assessment of protein intakes (as well as calcium, phosphorus, potassium and sodium intakes) between an FFQ questionnaire and a dietary record (24-hour recall) (Affret et al. 2017). This study shows an acceptable correlation between the FFQ and the dietary record (correlation coefficient between 0.05 and 0.79, with a median of 0.40), yet this study was carried out without dietary intervention and using a different type of dietary record. As in studies on a population of healthy adults, protein intakes assessed by any type of dietary questionnaire are not compared with a more reliable assessment of these same intakes (24-hour urine urea).
The proposed study will compare the concordance of dietary intake assessment between each of the 2 types of dietary collection (FFQ and a 3-day dietary collection) and 24-hour urine urea, which limits the biases inherent in dietary collection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic kidney disease | – | Other: 3-day dietary record, Other: Food Frequency Questionnaire (FFQ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease at stage 4 ou 5
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-day dietary recordThis is the conventional ingesta assessment. It will be performed twice during the study. | Other | Patients with chronic kidney disease |
| Food Frequency Questionnaire (FFQ)This questionnaire is used to obtain information on the frequency of foods and drinks consumed over a period of time (1 week, 1 month...). It will be performed twice during the study. | Other | Patients with chronic kidney disease |
Primary outcome
Estimation of the concordance between the reference method (24-hour urinary urea) and : (1) protein intake estimated by the 3-day dietary record ; (2) protein intakes estimated by FFQ via web application at the initial dietary consultation.
Time frame: Between 15 days and 1 month
6 secondary outcomes
Assessment of concordance between protein intake estimated by the 3-day dietary record and 24-hour urine urea measurement 6 months after the initial dietary consultation
Time frame: Between 6 and 7 months
Assessment of concordance between protein intakes estimated by FFQ via web application and 24-hour urine urea measurement 6 months after the initial dietary consultation
Time frame: Between 6 and 7 months
Evaluation and comparison of the time taken by the dietician to collect the data required to assess protein intake with the 2 types of dietary record at the initial dietary consultation
Time frame: Between 15 days and 1 month
Evaluation and comparison of the time taken by the dietician to collect the data required to assess protein intake with the 2 types of dietary record 6 months after the initial dietary consultation
Time frame: Between 6 and 7 months
Assessment of the concordance between nutritional intakes obtained by the 2 food collection methods at the initial dietary consultation
Time frame: Between 15 days and 1 month
Assessment of the concordance between nutritional intakes obtained by the 2 food collection methods 6 months after the initial dietary consultation
Time frame: Between 6 and 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François CREMIEUX study director
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease (stages 4 and 5), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie PRUDHOMME, Dietician (0491483092 ext. 33, valerie.prudhomme@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the concordance between the reference method (24-hour urinary urea) and : (1) protein intake estimated by the 3-day dietary record ; (2) protein intakes estimated by FFQ via web application at the initial dietary consultation. (time frame: Between 15 days and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.