RecruitingNot ApplicableNCT05489120

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

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


Sponsor

Dr. Schär AG / SPA

Enrollment

244 participants

Start Date

Nov 6, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of low-protein diets for people with chronic kidney disease (CKD): one that uses specially formulated low-protein food products, and one that reduces protein intake through regular food choices alone. Eating less protein can help slow the progression of kidney disease, but it can be hard to stick to. Researchers want to see which approach works better for patients. **You may be eligible if...** - You have stage 3a to 5 chronic kidney disease and are not on dialysis - You are currently eating more than 1g of protein per kilogram of body weight per day - You are in good nutritional status (not malnourished) - You have not tried a low-protein diet before - You are motivated to change your eating habits - You have health insurance coverage (France-based study) **You may NOT be eligible if...** - You are expected to start dialysis or receive a kidney transplant within 12 months - You have a known allergy to milk, eggs, soy, or nuts (ingredients in special diet products) - Your diabetes is poorly controlled (HbA1c above 8.5%) - You have active cancer, active infection, or an uncontrolled inflammatory disease - You have a psychiatric condition preventing you from following the protocol - You are currently enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERConsumption of FLAVIS

Patients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.


Locations(21)

Clinique sainte isabelle

Abbeville, France

Cabinet médical du Dr Magnant

Aix-en-Provence, France

CHU Besançon

Besançon, France

Maison du Rein

Bordeaux, France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France

CH Chalon

Chalon-sur-Saône, France

CHU Gabriel Montpied

Clermont-Ferrand, France

Santélys BFC

Dijon, France

CH Le Mans

Le Mans, France

Hospices Civiles de Lyon

Lyon, France

Hôpital Edouard Heriot

Lyon, France

Saint Joseph Saint Luc

Lyon, France

Hôpital la conception

Marseille, France

CH Mâcon

Mâcon, France

APHP - Hôpital Necker

Paris, France

AURA Paris

Paris, France

Tenon hospital -APHP

Paris, France

Hôpital Drôme Nord

Romans-sur-Isère, France

Nouvel Hôpital Civil

Strasbourg, France

Calydial

Vienne, France

Hôpital Nord-Ouest

Villefranche-sur-Saône, France

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NCT05489120


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