Consumption of FLAVIS
OtherPatients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.
NCT Number: NCT05489120
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Clinique sainte isabelle, Abbeville, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.
Time frame: 12 month
Maroni formula : (Measurement of urea in urine + ([patient weight]*0.031))*6.25
Time frame: 1 month, 3 month, 6 month and 9 month
Maroni formula: (Measurement of urea in urine + ([patient weight]*0.031))*6.25
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
3-day dietary record correlated to a 24-hour urine collection
Time frame: monthly up to 12 months
quantities consumed of FLAVIS products.
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.
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
Weight in kg
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
Water in litres
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
Muscles in Kg
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
Body protein content in Kg
Time frame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Blood Chemistry
Time frame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Urine Chemistry
Time frame: Baseline, 6 month and 12 month
Hb1Ac will be measured
Time frame: 1 month, 3 month, 6 month, 9 month and 12 month
Questioning and a clinical examination, biological analyses review
Time frame: 3 month, 6 month and 12 month
4-points Likert scale
Time frame: baseline, 3 month, 6 month and 12 month
SF-36 questionnaire score which from 0 to 100
Time frame: 3 month, 6 month and 12 month
Auto-questionnaire with numerical scales, closed-ended questions and Likert scales
Contact information is provided by the study sponsor or research team.
Dr. Schär AG / SPA
Industry
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
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.
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