Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD

December 16, 2024 updated by: Ari Cisneros-Hernández, NIN Institute

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm Intervention
Intervention group: The specialized oral supplement is provided, with the consumption of 1 serving (70g-dissolved in 237 ml natural water) per day in conjunction with individualized nutritional counseling. For 4 months
Dietary supplement: Nutritious Shake
Powder 70 g/d diluted in 237 ml natural water
Other Names:
  • NIN
Other: Arm no Intervention
Control group: They receive specialized nutrition considering the recommendations of the clinical practice guidelines for CKD. For 4 months
Behavioral: Nutritional counseling
Specialized nutritional recommendations for CKD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary intake (kcal/kg/day)
Time Frame: baseline intervention and 4 months
Changes in dietary caloric intake of patients at baseline and month 4.
baseline intervention and 4 months
Serum Albumin (g/dl)
Time Frame: baseline intervention and 4 months
Changes in serum albumin (g/dl) for all the patients at baseline and month 4.
baseline intervention and 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to nutritional treatment
Time Frame: baseline intervention and 4 months
Number of patients who manage to adhere correctly to the treatment, applying a Likert scale.
baseline intervention and 4 months
Adverse effects
Time Frame: baseline intervention and 4 months
Number of patients who present adverse effects during the intervention, considering frequency and intensity by applying SAS (symptom assessment scale) and Bristol Scale.
baseline intervention and 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NIN Institute

Collaborators

Hospital Civil de Guadalajara

Investigators

  • Principal Investigator: Paola Azucena Alvarado Pelayo, Bachelor, Hospital Civil Fray Antonio Alcalde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2018

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

August 19, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI0001/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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