Clinical trial NCT06576479: Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
Official title: Validation of the Therapeutic Effect and Safety of a Specialized Oral Supplement on the Nutritional Status and Quality of Life in Patients with Chronic Kidney Disease Without Replacement Therapy: (Grade G3a, G3b, G4 and G5)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Protein-Energy Malnutrition
Keywords: chronic kidney disease
PEW
nutrition
Lead sponsor: NIN Institute
Sponsor class: INDUSTRY
Collaborators: name: Hospital Civil de Guadalajara
First posted: 2024-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The intervention group receives specialized oral nutritional supplements plus nutritional counseling, the control group only receives nutrition counseling. Both groups receive laboratory studies (blood and urine) as well as body composition analysis with the use of electronic bioimpedance.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Epidemiological studies have reported that between 30 and 50% of patients with kidney disease show signs of malnutrition and that specifically in patient with CKD in stages 4-5 without replacement therapy, the prevalence of protein energy wasting (PEW) can be up to 45%.

Many factors influence the development of PEW, however, one main factor is insufficient intake of energy and macronutrients. The main obstacle that prevents the patient from meeting their nutritional requirements is the presence of gastrointestinal symptoms. In addition to this, dietary restrictions, lack of adherence to eating plans and the presence of digestive and psychological abnormalities of the patient, contribute directly to the patient directly contribute to insufficient energy and protein intake. Therefore, there is a need for evidence-based nutritional treatment strategies that facilitate the patient's achievement of their nutritional requirements and maintain or improve their nutritional supplements in patients with CKD has been shown to be a good treatment strategy.

Specifically in patients with CKD without replacement therapy, it has been observed that the use of specialized nutritional supplements can contribute to increasing their energy, fat, and fiber intake, while at the same time achieving a decrease in protein intake without causing any change in serum minerals or electrolytes.

This project will provide practical information for the validation of the therapeutic effect of a new specialized food supplement on the nutritional status and quality of life in patients with CKD without replacement therapy, which will be useful both for health professionals and for the patients themselves.

MAIN OBJETIVE:

To assess the effect and safety of the use of a specialized food supplement on the nutritional status and quality of life of patients with CKD and PEW without replacement therapy.

STUDIO DESING:

Randomized, blinded clinical trial with an intervention period of 4 months.

PROCESS:

1. Identify those patients who are candidates to participate in the clinical trial.
2. Review the inclusion and exclusion criteria.
3. Invite identified patients to participate in the clinical trial.

Pre - Nutritional wash out appointment - nutritionist

1. Evaluate inclusion criteria.
2. Review and sign the informed consent.
3. Perform evaluation to indicate a personalized meal plan.
4. Deliver a meal plan.
5. Schedule in 30 days for your next nutritional appointment.

0 - Full Assessment Nutritional Appointment - Nutritionist

1. Evaluate adherence to the meal plan (percentage of adequacy of energy and protein consumption from 70% to 130%).
2. Assign an intervention group randomly (sealed envelope).
3. Perform an evaluation of nutritional status, quality of life and body composition.

   Offer nutritional treatment according to the assigned intervention group.
4. Schedule an immediate appointment for laboratory tests of blood and urine.
5. Schedule in 30 days for your next nutritional appointment.

month 1 - Nutritional monitoring appointment - nutritionist

1. Evaluate adherence to the eating plan.
2. Offer nutritional treatment according to the assigned intervention group.
3. Schedule in 30 days for your next nutritional appointment.
4. Make an appointment a few days before your next nutritional appointment to perform blood and urine lab tests.

month 2 - Full Assessment Nutritional Appointment - Nutritionist

1. Perform an evaluation of nutritional status, quality of life and body composition.
2. Offer nutritional treatment according to the assigned intervention group.
3. Schedule in 30 days for your next nutritional appointment.

month 3 - Nutritional monitoring appointment - nutritionist

1. Evaluate adherence to the eating plan.
2. Offer nutritional treatment according to the assigned intervention group.
3. Schedule in 30 days for your next nutritional appointment. 4.3 - Nutritional monitoring appointment - nutritionist

5.Evaluate adherence to the eating plan. 6.Offer nutritional treatment according to the assigned intervention group. 7.Schedule in 30 days for your next nutritional appointment. 7.1Schedule a few days before your nutritional appointment for blood and urine lab tests.

month 4 - Full Assessment Nutritional Appointment - Nutritionist

1. Perform an evaluation of nutritional status, quality of life and body composition.
2. Offer nutritional treatment according to the assigned intervention group.

SAMPLE SIZE: 50 participants

STATISTIC ANALYSIS:

For the comparison of proportions between the groups, it will be done with X2 or Fisher's exact test and to compare quantitative variables, Student's T or Mann-Whitney U will be used. For the intra-group comparisons, Mc Nemar will be used for the qualitative variables and Anova for repeated samples or Friedman's Anova for the quantitative variables. For the analysis of the interaction or intervening variables, a stratified statistical analysis will be carried out, using contingency tables and the Mantel-Haenszel method. The results will be considered statistically significant if the value of p \<0.05.

Eligibility criteria: Inclusion Criteria:

* 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
* Patients who can read and write (or primary caregiver)
* Domicile within the metropolitan area

Exclusion Criteria:

* 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.

Elimination Criteria:

* Failure to attend nutritional assessment and biochemical testing at baseline, 2 months, and end of the study.
* Failure to take the supplement \>10% (\>12 failed doses).
* Diagnosis of any comorbidity during the intervention period.
* Initiation of replacement therapy.
* Identification of adverse effects.
* Withdrawal of voluntary participation by the patient.
* Death.

Primary outcomes:
measure: Serum Albumin (g/dl)
timeFrame: baseline intervention and 4 months
measure: Dietary intake (kcal/kg/day)
timeFrame: baseline intervention and 4 months
Secondary outcomes:
measure: Adherence to nutritional treatment
timeFrame: baseline intervention and 4 months
measure: Adverse effects
timeFrame: baseline intervention and 4 months
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
state: Jalisco
Study officials:
affiliation: Hospital Civil Fray Antonio Alcalde
name: Paola Azucena Alvarado Pelayo, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
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