Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576479
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 43 - Nutritional monitoring appointment - nutritionist
5Evaluate adherence to the eating plan 6Offer nutritional treatment according to the assigned intervention group 7Schedule in 30 days for your next nutritional appointment 71Schedule 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 Fishers exact test and to compare quantitative variables Students 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 Friedmans 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 005
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 patients 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 43 - Nutritional monitoring appointment - nutritionist
5Evaluate adherence to the eating plan 6Offer nutritional treatment according to the assigned intervention group 7Schedule in 30 days for your next nutritional appointment 71Schedule 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 Fishers exact test and to compare quantitative variables Students 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 Friedmans 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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None