Chronic Kidney DiseasesNCT06576479
Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
A study testing Nutritious Shake and Nutritional counseling in people with Chronic Kidney Diseases and Protein-Energy Malnutrition, run by NIN Institute at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Diseases, Protein-Energy Malnutrition
- What is being tested?
- Nutritious Shake and Nutritional counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 10 Jul 2018to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 11Show fewer
- Diagnosis of any comorbidity during the intervention period.
- Initiation of replacement therapy.
- Identification of adverse effects.
- Withdrawal of voluntary participation by the patient.
- Death.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
Paola Alvarado, Bachelor, 011 52 3320587471, paola.alvarado@nin.com.mx
Ari Cisneros, Master, 3335762299, aricisneroshernandez@gmail.com
About this study
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)
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.
Read the 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:
- Identify those patients who are candidates to participate in the clinical trial.
- Review the inclusion and exclusion criteria.
- Invite identified patients to participate in the clinical trial.
Pre - Nutritional wash out appointment - nutritionist
- Evaluate inclusion criteria.
- Review and sign the informed consent.
- Perform evaluation to indicate a personalized meal plan.
- Deliver a meal plan.
- Schedule in 30 days for your next nutritional appointment.
0 - Full Assessment Nutritional Appointment - Nutritionist
- Evaluate adherence to the meal plan (percentage of adequacy of energy and protein consumption from 70% to 130%).
- Assign an intervention group randomly (sealed envelope).
- Perform an evaluation of nutritional status, quality of life and body composition. Offer nutritional treatment according to the assigned intervention group.
- Schedule an immediate appointment for laboratory tests of blood and urine.
- Schedule in 30 days for your next nutritional appointment. month 1 - Nutritional monitoring appointment - nutritionist
- Evaluate adherence to the eating plan.
- Offer nutritional treatment according to the assigned intervention group.
- Schedule in 30 days for your next nutritional appointment.
- 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
- Perform an evaluation of nutritional status, quality of life and body composition.
- Offer nutritional treatment according to the assigned intervention group.
- Schedule in 30 days for your next nutritional appointment. month 3 - Nutritional monitoring appointment - nutritionist
- Evaluate adherence to the eating plan.
- Offer nutritional treatment according to the assigned intervention group.
- 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
- Perform an evaluation of nutritional status, quality of life and body composition.
- 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.
- Being tested
- Nutritious Shake, Nutritional counseling
- Keywords
- chronic kidney disease, PEW, nutrition
- Medical subject headings
- Renal Insufficiency, Chronic, Protein-Energy Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritious ShakeDietary supplement
Also called NIN
Powder 70 g/d diluted in 237 ml natural water
Nutritional counselingBehavioural
Specialized nutritional recommendations for CKD
| Study group | Role | What they receive |
|---|---|---|
| Arm Intervention | Experimental | 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 Receives: Dietary Supplement: Nutritious Shake |
| Arm no Intervention | Other | Control group: They receive specialized nutrition considering the recommendations of the clinical practice guidelines for CKD. For 4 months Receives: Behavioral: Nutritional counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Albumin (g/dl)
Changes in serum albumin (g/dl) for all the patients at baseline and month 4.
Measured: baseline intervention and 4 months
Dietary intake (kcal/kg/day)
Changes in dietary caloric intake of patients at baseline and month 4.
Measured: baseline intervention and 4 months
Secondary outcomes (2)
Adherence to nutritional treatment
Number of patients who manage to adhere correctly to the treatment, applying a Likert scale.
Measured: baseline intervention and 4 months
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.
Measured: baseline intervention and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start10 Jul 2018
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NIN Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Civil de Guadalajara
- Responsible party
- Principal investigator, Ari Cisneros-Hernández, Hospital Civil de Guadalajara
- Investigators
- Paola Azucena Alvarado Pelayo, Bachelor, Principal investigator, Hospital Civil Fray Antonio Alcalde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576479
- Sponsor's protocol ID
- NI0001/24
- Status last verified
- Dec 2024
- First submitted
- 19 Aug 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23428357Riella 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.
PubMed 23611546Perez-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.
PubMed 28755901Kovesdy 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.
PubMed 23636234Zhang 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.
PubMed 26651991Paes-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.
PubMed 23194841Tomayko 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.
PubMed 25455421Kalantar-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.
PubMed 21629229Cheu 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.
PubMed 23085729Satirapoj 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.
PubMed 27103839
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06576479
- Acronym / sponsor ID
- NI0001/24
- Keywords
- chronic kidney disease, PEW, nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NIN InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Civil de Guadalajara
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Identify those patients who are candidates to participate in the clinical trial.
- Review the inclusion and exclusion criteria.
- Invite identified patients to participate in the clinical trial.
Pre - Nutritional wash out appointment - nutritionist
- Evaluate inclusion criteria.
- Review and sign the informed consent.
- Perform evaluation to indicate a personalized meal plan.
- Deliver a meal plan.
- Schedule in 30 days for your next nutritional appointment.
0 - Full Assessment Nutritional Appointment - Nutritionist
- Evaluate adherence to the meal plan (percentage of adequacy of energy and protein consumption from 70% to 130%).
- Assign an intervention group randomly (sealed envelope).
- Perform an evaluation of nutritional status, quality of life and body composition. Offer nutritional treatment according to the assigned intervention group.
- Schedule an immediate appointment for laboratory tests of blood and urine.
- Schedule in 30 days for your next nutritional appointment. month 1 - Nutritional monitoring appointment - nutritionist
- Evaluate adherence to the eating plan.
- Offer nutritional treatment according to the assigned intervention group.
- Schedule in 30 days for your next nutritional appointment.
- 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
- Perform an evaluation of nutritional status, quality of life and body composition.
- Offer nutritional treatment according to the assigned intervention group.
- Schedule in 30 days for your next nutritional appointment. month 3 - Nutritional monitoring appointment - nutritionist
- Evaluate adherence to the eating plan.
- Offer nutritional treatment according to the assigned intervention group.
- 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
- Perform an evaluation of nutritional status, quality of life and body composition.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm Intervention | Experimental | Dietary Supplement: Nutritious ShakeIntervention 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 |
| Arm no Intervention | Other | Behavioral: Nutritional counselingControl group: They receive specialized nutrition considering the recommendations of the clinical practice guidelines for CKD. For 4 months |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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.
- Failure to take the supplement >10% (>12 failed doses).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritious ShakeAlso: NINPowder 70 g/d diluted in 237 ml natural water | Dietary supplement | Arm Intervention |
| Nutritional counselingSpecialized nutritional recommendations for CKD | Behavioural | Arm no Intervention |
Primary outcome
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.
Dietary intake (kcal/kg/day)
Time frame: baseline intervention and 4 months
Changes in dietary caloric intake of patients at baseline and month 4.
2 secondary outcomes
Adherence to nutritional treatment
Time frame: baseline intervention and 4 months
Adverse effects
Time frame: baseline intervention and 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Background: PubMed 23428357Carrero 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.
- Background: PubMed 23611546Riella 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.
- Background: PubMed 28755901Perez-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.
- Background: PubMed 23636234Kovesdy 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.
- Background: PubMed 26651991Zhang 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.
- Background: PubMed 23194841Paes-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.
- Background: PubMed 25455421Tomayko 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.
- Background: PubMed 21629229Kalantar-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.
- Background: PubMed 23085729Cheu 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.
- Background: PubMed 27103839Satirapoj 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paola Azucena Alvarado Pelayo, Bachelor principal investigator
Hospital Civil Fray Antonio Alcalde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritious Shake and Nutritional counseling in people with Chronic Kidney Diseases and Protein-Energy Malnutrition, run by NIN Institute at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Azucena Alvarado Pelayo, Bachelor (011 52 3320587471, paola.alvarado@nin.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Albumin (g/dl) (time frame: baseline intervention and 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06576479, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.