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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-06

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease Stage 3B Chronic Kidney Disease stage4 Chronic Kidney Disease Stage 5 Chronic Kidney Disease Stage 3A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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COMPARATOR

Follow-up of the CKD patient according to current practice i.e. low protein diet.

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Consumption of FLAVIS

Intervention Type OTHER

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

Interventions

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Consumption of FLAVIS

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No