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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDr. Schär AG / SPA

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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),

Trial design

Design model

Parallel

Treatments tested in this trial

  • Consumption of FLAVIS

    Other intervention

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

Treatment groups

244 Participants
are divided into 2 treatment groups
Group A: COMPARATORNo intervention 0 interventions
Group B: FLAVISExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Effectiveness in terms of protein intake of a LPD with LP foods (FLAVIS products) compared to standard products (LPD without consumption of LP foods)

Maroni formula : (Measurement of urea in urine + (\[patient weight\]\*0.031))\*6.25

Time frame
12 month

Secondary outcomes

1

Protein intake during the 12 months follow-up

Maroni formula: (Measurement of urea in urine + (\[patient weight\]\*0.031))\*6.25

Time frame
1 month, 3 month, 6 month and 9 month
2

Dietary adherence

3-day dietary record correlated to a 24-hour urine collection

Time frame
baseline, 1 month, 3 month, 6 month and 12 month
3

Dietary compliance for products under study

quantities consumed of FLAVIS products.

Time frame
monthly up to 12 months
4

Effects of the LPD on BMI

Weight and height will be combined to report BMI in kg/m\^2.

Time frame
baseline, 1 month, 3 month, 6 month and 12 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Schär AG / SPA

Lead sponsor

Slb Pharma

Collaborator