Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05489120

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Consumption of FLAVIS

Other

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

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)

    Time frame: 12 month

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

Secondary outcomes

  1. 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

  2. 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

  3. Dietary compliance for products under study

    Time frame: monthly up to 12 months

    quantities consumed of FLAVIS products.

  4. 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.

  5. Effects of the LPD on weight

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

    Weight in kg

  6. Effects of the LPD on body composition: water

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

    Water in litres

  7. Effects of the LPD on body composition: muscles

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

    Muscles in Kg

  8. 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

  9. Effects of the LPD on Blood

    Time frame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month

    Blood Chemistry

  10. Effects of the LPD on Urine

    Time frame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month

    Urine Chemistry

  11. Effects of the LPD on diabetic patient glycemic profile

    Time frame: Baseline, 6 month and 12 month

    Hb1Ac will be measured

  12. 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

  13. Incidence of Adverse Events [Safety of the LPD]

    Time frame: 3 month, 6 month and 12 month

    4-points Likert scale

  14. Patient quality of life

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

    SF-36 questionnaire score which from 0 to 100

  15. Patient satisfaction with LPD

    Time frame: 3 month, 6 month and 12 month

    Auto-questionnaire with numerical scales, closed-ended questions and Likert scales

Study contacts

Contact information is provided by the study sponsor or research team.

Ophélie Flageul

CONTACT

[email protected]

0299121962 ext. +33

Vinciane Dumay

CONTACT

[email protected]

0756917356 ext. +33

Sponsors and collaborators

Lead sponsor

Dr. Schär AG / SPA

Industry

Collaborators

  • Slb Pharma

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2022
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.