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Special foods could make Low-Protein diets easier for kidney patients

NCT ID NCT05489120

Disease control Sponsor: Dr. Schär AG / SPA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial tests whether adding specially formulated low-protein foods (FLAVIS products) to a standard low-protein diet helps people with chronic kidney disease (stages 3a-5) better control their protein intake. Participants will be randomly assigned to either a low-protein diet with these special foods or one without. The study will measure protein intake and adherence over time to see if the special foods make it easier to follow the diet.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A low-protein diet supplemented with specially formulated low-protein foods (FLAVIS products)
What this could lead to
If effective, this approach could help people with chronic kidney disease better follow a low-protein diet, potentially slowing disease progression and improving quality of life.
What could go wrong
The trial is relatively small and the benefit may be modest. Adherence to the diet and the special foods could be challenging, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

210 people

The number who actually took part.

Started

Nov 2022

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome end stage renal failure Patient Compliance

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease stage 3A Chronic kidney disease stage 3B Chronic kidney disease stage 5 Chronic kidney disease STAGE4

Contacts and locations

Locations

  • APHP - Hôpital Necker

    Paris, France

  • CH Chalon

    Chalon-sur-Saône, France

  • CH Le Mans

    Le Mans, France

  • CH Mâcon

    Mâcon, France

  • CHU Besançon

    Besançon, France

  • CHU Gabriel Montpied

    Clermont-Ferrand, France

  • Cabinet médical du Dr Magnant

    Aix-en-Provence, France

  • Calydial

    Vienne, France

  • Clinique sainte isabelle

    Abbeville, 80100, France

  • Hospices Civiles de Lyon

    Lyon, France

  • Hôpital Drôme Nord

    Romans-sur-Isère, France

  • Hôpital Nord-Ouest

    Villefranche-sur-Saône, France

  • Hôpital la conception

    Marseille, France

  • Maison du Rein

    Bordeaux, France

  • Nouvel Hôpital Civil

    Strasbourg, France

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, France

  • Saint Joseph Saint Luc

    Lyon, France

  • Tenon hospital -APHP

    Paris, France

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