Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNIN Institute
About this trial
Patients whit chronic kidney disease (CKD) there is a high prevalence of nutritional disorders and negative changes in body composition, which is strongly associated with an increased risk of morbidity and mortality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 18 years of age
Patients with diabetic kidney with eGFR <60 ml / min / 1.73m2 and ≥15 ml / min / 1.73m2, (stage G3a, G3b and G4 respectively)
Patients with protein energy expenditure (defined by serum albumin < 3.8 g/dl)
Patients with protein energy expenditure (defined by 24-hour recall less than a dietary protein intake <0.6 g/kg/d or have a consumption <25 kcal/kg/d
Disqualifiers
Previous hospitalizations in the last month
Patients with serious complications (chronic infection, septicemia, cancer, HIV, Alzheimer's, uncontrolled heart failure, liver failure, cerebrovascular syndrome, malabsorption syndrome, or allergy to any ingredient in the nutritional supplement)
Patients with actual consumption of food supplements and / or keto analogues.
Failure to attend nutritional assessment and biochemical testing at baseline, 2 months, and end of the study.
Trial design
Design model
Factorial
Treatments tested in this trial
Nutritious Shake
Dietary supplementPowder 70 g/d diluted in 237 ml natural water
Nutritional counseling
BehavioralSpecialized nutritional recommendations for CKD
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Arm InterventionExperimental treatment 1 intervention
Group B: Arm no InterventionOther 1 intervention
Trial outcomes
Primary outcomes
1
Serum Albumin (g/dl)
Changes in serum albumin (g/dl) for all the patients at baseline and month 4.
Time frame
baseline intervention and 4 months2
Dietary intake (kcal/kg/day)
Changes in dietary caloric intake of patients at baseline and month 4.
Time frame
baseline intervention and 4 monthsSecondary outcomes
1
Adherence to nutritional treatment
Number of patients who manage to adhere correctly to the treatment, applying a Likert scale.
Time frame
baseline intervention and 4 months2
Adverse effects
Number of patients who present adverse effects during the intervention, considering frequency and intensity by applying SAS (symptom assessment scale) and Bristol Scale.
Time frame
baseline intervention and 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
NIN Institute
Lead sponsor
Hospital Civil de Guadalajara
Sponsor institution
Hospital Civil de Guadalajara
Collaborator
Source ClinicalTrials.gov