Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
NCT ID: NCT06576479
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2018-07-10
2025-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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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
Nutritious Shake
Powder 70 g/d diluted in 237 ml natural water
Arm no Intervention
Control group: They receive specialized nutrition considering the recommendations of the clinical practice guidelines for CKD. For 4 months
Nutritional counseling
Specialized nutritional recommendations for CKD
Interventions
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Nutritious Shake
Powder 70 g/d diluted in 237 ml natural water
Nutritional counseling
Specialized nutritional recommendations for CKD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
90 Years
ALL
No
Sponsors
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Hospital Civil de Guadalajara
OTHER
NIN Institute
INDUSTRY
Responsible Party
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Ari Cisneros-Hernández
Investigador Principal
Principal Investigators
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Paola Azucena Alvarado Pelayo, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Hospital Civil Fray Antonio Alcalde
Locations
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Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Countries
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Central Contacts
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Paola Azucena Alvarado Pelayo, Bachelor
Role: CONTACT
Phone: 011 52 3320587471
Email: [email protected]
Facility Contacts
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Paola Alvarado, Bachelor
Role: primary
Ari Cisneros, Master
Role: backup
References
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Carrero JJ, Stenvinkel P, Cuppari L, Ikizler TA, Kalantar-Zadeh K, Kaysen G, Mitch WE, Price SR, Wanner C, Wang AY, ter Wee P, Franch HA. Etiology of the protein-energy wasting syndrome in chronic kidney disease: a consensus statement from the International Society of Renal Nutrition and Metabolism (ISRNM). J Ren Nutr. 2013 Mar;23(2):77-90. doi: 10.1053/j.jrn.2013.01.001.
Riella MC. Nutritional evaluation of patients receiving dialysis for the management of protein-energy wasting: what is old and what is new? J Ren Nutr. 2013 May;23(3):195-8. doi: 10.1053/j.jrn.2013.01.023.
Perez-Torres A, Gonzalez Garcia ME, San Jose-Valiente B, Bajo Rubio MA, Celadilla Diez O, Lopez-Sobaler AM, Selgas R. Protein-energy wasting syndrome in advanced chronic kidney disease: prevalence and specific clinical characteristics. Nefrologia (Engl Ed). 2018 Mar-Apr;38(2):141-151. doi: 10.1016/j.nefro.2017.06.004. Epub 2017 Jul 26. English, Spanish.
Kovesdy CP, Kopple JD, Kalantar-Zadeh K. Management of protein-energy wasting in non-dialysis-dependent chronic kidney disease: reconciling low protein intake with nutritional therapy. Am J Clin Nutr. 2013 Jun;97(6):1163-77. doi: 10.3945/ajcn.112.036418. Epub 2013 May 1.
Zhang X, Bansal N, Go AS, Hsu CY. Gastrointestinal symptoms, inflammation and hypoalbuminemia in chronic kidney disease patients: a cross-sectional study. BMC Nephrol. 2015 Dec 11;16:211. doi: 10.1186/s12882-015-0209-z.
Paes-Barreto JG, Silva MI, Qureshi AR, Bregman R, Cervante VF, Carrero JJ, Avesani CM. Can renal nutrition education improve adherence to a low-protein diet in patients with stages 3 to 5 chronic kidney disease? J Ren Nutr. 2013 May;23(3):164-71. doi: 10.1053/j.jrn.2012.10.004. Epub 2012 Nov 27.
Tomayko EJ, Kistler BM, Fitschen PJ, Wilund KR. Intradialytic protein supplementation reduces inflammation and improves physical function in maintenance hemodialysis patients. J Ren Nutr. 2015 May;25(3):276-83. doi: 10.1053/j.jrn.2014.10.005. Epub 2014 Nov 25.
Kalantar-Zadeh K, Cano NJ, Budde K, Chazot C, Kovesdy CP, Mak RH, Mehrotra R, Raj DS, Sehgal AR, Stenvinkel P, Ikizler TA. Diets and enteral supplements for improving outcomes in chronic kidney disease. Nat Rev Nephrol. 2011 May 31;7(7):369-84. doi: 10.1038/nrneph.2011.60.
Cheu C, Pearson J, Dahlerus C, Lantz B, Chowdhury T, Sauer PF, Farrell RE, Port FK, Ramirez SP. Association between oral nutritional supplementation and clinical outcomes among patients with ESRD. Clin J Am Soc Nephrol. 2013 Jan;8(1):100-7. doi: 10.2215/CJN.13091211. Epub 2012 Oct 18.
Satirapoj B, Prapakorn J, Punpanich D, Pongsuparbchon C, Supasyndh O. The effect of ONCE Renal on minerals and electrolytes in predialysis patients with chronic kidney disease. Int J Nephrol Renovasc Dis. 2016 Apr 5;9:81-6. doi: 10.2147/IJNRD.S98179. eCollection 2016.
Other Identifiers
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NI0001/24
Identifier Type: -
Identifier Source: org_study_id