Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)

August 13, 2026 updated by: Dr. Schär AG / SPA

Randomized Controlled Trial of a Low-Protein Diet (LPD) With Low-Protein (LP) Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD): Efficacy and Feasibility Study

The KDOQI 2020 - Clinical practice guideline for nutrition in chronic kidney disease (CKD) -recommends protein restriction to reduce the risk of end-stage renal disease/death and improve quality of life, a low protein diet providing 0.55-0.60g dietary protein/ kg body weight/day is recommended. FLAVIS® is a product line of hypoprotein foods specially developed for the treatment of CKD.The use of low-protein foods may facilitate the achievement of nutritional goals in terms of protein intake and help patients to follow a low-protein diet.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Abbeville, France, 80100
        • Clinique sainte isabelle
      • Aix-en-Provence, France
        • Cabinet médical du Dr Magnant
      • Besançon, France
        • CHU Besançon
      • Bordeaux, France
        • Maison du Rein
      • Bordeaux, France
        • Polyclinique Bordeaux Nord Aquitaine
      • Chalon-sur-Saône, France
        • CH Chalon
      • Clermont-Ferrand, France
        • Chu Gabriel Montpied
      • Le Mans, France
        • CH Le Mans
      • Lyon, France
        • Hospices Civiles de Lyon
      • Lyon, France
        • Saint Joseph Saint Luc
      • Marseille, France
        • Hôpital la conception
      • Mâcon, France
        • CH Mâcon
      • Paris, France
        • APHP - Hôpital Necker
      • Paris, France
        • Tenon hospital -APHP
      • Romans-sur-Isère, France
        • Hôpital Drôme Nord
      • Strasbourg, France
        • Nouvel Hopital Civil
      • Vienne, France
        • Calydial
      • Villefranche-sur-Saône, France
        • Hôpital Nord-Ouest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • CKD patient stage 3a-5 (<60 ml/min/1.73 m² estimated by CKD-EPI formula) and not on dialysis,
  • With a good nutritional status (i.e., absence of malnutrition according to albumin, pre-albumine, BMI and no clinical and paraclinical criteria of malnutrition),
  • Above 1g protein/ kg bw (ideal body weight),
  • LPD-naïve patient,
  • Motivated to LPD introduction (ensure during screening phase patient willingness to modify diet habits with counselling accurate follow-up),
  • Available to attend the visits planned by the protocol and able to complete the data collection documents (diet record and self-administered questionnaires),
  • Subject affiliated to a health insurance system or is a beneficiary (art. L.1121-11, Code of Public Health, France),
  • Having given their informed written consent regarding its participation to the protocol.

Exclusion Criteria:

  • Patient for whom dialysis or transplantation is planned/expected within the next 12 months
  • Known allergic reactions to the ingredients present in FLAVIS products (milk, eggs, soy, nut),
  • Uncontrolled Diabetes (HbA1C >8.5%),
  • Active cancer (including a 5 years remission period),
  • Psychiatric disorders or inability to follow the protocol,
  • Evidence of any active infectious or uncontrolled inflammatory diseases,
  • Inability to provide blood samples (poor venous capital),
  • Inability to perform correct 24-hours urine collection,
  • Any change of the chronic medication within 1 month before screening,
  • Presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator,
  • Patient with an active implanted medical device
  • Simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial.
  • Vulnerable subjects (art. L. 1121-5 à 8 et L. 1122-1-2, Code of Public Health, France) are also excluded from the clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: COMPARATOR
Follow-up of the CKD patient according to current practice i.e. low protein diet.
Experimental: FLAVIS
Follow-up of the CKD patient according to the current practice i.e. low protein diet with the addition of of low-protein products (FLAVIS).
Other: Consumption of FLAVIS
Patients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effectiveness in terms of protein intake of a LPD with LP foods (FLAVIS products) compared to standard products (LPD without consumption of LP foods)
Time Frame: 12 month
Maroni formula : (Measurement of urea in urine + ([patient weight]*0.031))*6.25
12 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Protein intake during the 12 months follow-up
Time Frame: 1 month, 3 month, 6 month and 9 month
Maroni formula: (Measurement of urea in urine + ([patient weight]*0.031))*6.25
1 month, 3 month, 6 month and 9 month
Dietary adherence
Time Frame: baseline, 1 month, 3 month, 6 month and 12 month
3-day dietary record correlated to a 24-hour urine collection
baseline, 1 month, 3 month, 6 month and 12 month
Dietary compliance for products under study
Time Frame: monthly up to 12 months
quantities consumed of FLAVIS products.
monthly up to 12 months
Effects of the LPD on weight
Time Frame: baseline, 1 month, 3 month, 6 month and 12 month
Weight in kg
baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: water
Time Frame: baseline, 1 month, 3 month, 6 month and 12 month
Water in litres
baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: muscles
Time Frame: baseline, 1 month, 3 month, 6 month and 12 month
Muscles in Kg
baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: body protein content
Time Frame: baseline, 1 month, 3 month, 6 month and 12 month
Body protein content in Kg
baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on Blood
Time Frame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Blood Chemistry
baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Effects of the LPD on Urine
Time Frame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Urine Chemistry
baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Patient quality of life
Time Frame: baseline, 3 month, 6 month and 12 month
SF-36 questionnaire score which from 0 to 100
baseline, 3 month, 6 month and 12 month
Effects of the LPD on BMI
Time Frame: baseline, 1 month, 3 month, 6 month and 12 month
Weight and height will be combined to report BMI in kg/m^2.
baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on diabetic patient glycemic profile
Time Frame: Baseline, 6 month and 12 month
Hb1Ac will be measured
Baseline, 6 month and 12 month
Incidence of Adverse Events [Safety of the LPD]
Time Frame: 1 month, 3 month, 6 month, 9 month and 12 month
Questioning and a clinical examination, biological analyses review
1 month, 3 month, 6 month, 9 month and 12 month
Incidence of Adverse Events [Safety of the LPD]
Time Frame: 3 month, 6 month and 12 month
4-points Likert scale
3 month, 6 month and 12 month
Patient satisfaction with LPD
Time Frame: 3 month, 6 month and 12 month
Auto-questionnaire with numerical scales, closed-ended questions and Likert scales
3 month, 6 month and 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Schär AG / SPA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Slb Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Laetitia Koppe, Dr, HCL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 24, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EFFLAVIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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