Chronic Kidney Disease Requiring Chronic DialysisNCT05288101
Effect of Oral Nutritional Supplementation Combined With Impedance Vectors
A study testing Proteinex and Enterex DBT Victus Laboratories and Dry weight adjustment through BIVA in people with Chronic Kidney Disease Requiring Chronic Dialysis and Overhydration, run by Universidad Autonoma de Queretaro at 1 site in Mexico.
Trial summary
The objective of this study was to assess the effect of oral nutritional supplementation (ONS) combined with bioelectrical vector analysis (BIVA) on the nutritional and hydration status and the quality of life (QoL) in hemodialysis (HD) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis, Overhydration, Undernutrition
- What is being tested?
- Proteinex and Enterex DBT Victus Laboratories and Dry weight adjustment through BIVA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2017to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on chronic HD undergoing thrice weekly hemodialysis (at least three hours per treatment) for more than three months were included.
Who cannot join
- Patients with amputations of any limb, metal implants, diagnosis of dementia, or current consumption of nutritional supplements were excluded.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
HD unit of the Social Security Institute for Government Employees (ISSSTE as per initials in Spanish
Querétaro, 76000
About this study
Official title: Effect of Oral Nutritional Supplementation Combined With Impedance Vectors for Dry Weight Adjustment on the Nutritional Status, Hydration Status and Quality of Life in Patients on Chronic Hemodialysis: a Pilot Study
The objective of this study was to assess the effect of oral nutritional supplementation (ONS) combined with bioelectrical vector analysis (BIVA) on the nutritional and hydration status and the quality of life (QoL) in hemodialysis (HD) patients. Design and Methods: Thirty-two chronic HD patients were included in a 6-month randomized pilot study. Patients in SUPL group received a simultaneous intervention consisting of a personalized diet, 245 mL/d ONS and dry weight adjustment through BIVA. Patients in CON group received a personalized diet and dry weight adjustment by BIVA. Anthropometrical, biochemical, dietary, QoL, handgrip strength (HGS) and bioimpedance measurements were performed. Malnutrition Inflammation Score (MIS) was applied.
Read the detailed description
This was a randomized, controlled, pilot study. Due to the type of study, no sample size was calculated because the aim was to include all patients available . Patients were randomly assigned to one of two treatments: 1) simultaneous intervention of dry weight adjustment through BIVA, a personalized diet, and 245 mL/d of ONS (SUPL), or 2) dry weight adjustment by BIVA and a personalized diet (CON). Both treatments were given for six months All measurements were made in accordance with good clinical practice and the recommendations of the Helsinki Declaration on human studies. The protocol was registered and approved by the Ethics Committee of the Faculty of Natural Science of the Autonomous University of Queretaro (No. 252FCN2016) and by the Ethics Committee of the ISSSTE in Queretaro. All patients provided written informed consent to participate in this study.
The supplement was provided five days per week. Three days a week, the supplement was given at the beginning of the HD session and the patients were instructed to consume it slowly during the next 3 hours. The remaining two days, the supplement was consumed at home and instructed to be consumed between meals.
The ONS consisted of one can of polymeric formula (Enterex DBT, Victus Laboratories) and 5.6 g of a protein powder supplement (Proteinex, Victus Laboratories). The final mixture provided 240 kcal, 17 g protein, 8.1 g lipids, 25 g carbohydrates, 4 g dietary fiber, 201 mg sodium, 490 mg calcium, 356 mg phosphorus and 371 mg potassium. When the ONS was provided at the HD unit, the mixture was prepared at the hospital´s enteral mixing center and delivered to the patient in a plastic cup with lid and a straw. For the two remaining days, the patients were instructed about the mixture preparation and they were given two cans of supplement and two sealed plastic bags with 5.6 grams of protein powder each one. Adherence to supplement intake was determined by recording the number of servings consumed weekly. For this purpose, at the end of each HD session, the plastic cups were collected to ensure the total consumption of the supplement and for the ONS consumed at home, the patients were asked to return empty cans and plastic bags to the research staff.
Both groups received the intervention to adjust dry weight in order to reach normohydration. Those participants with post-dialysis vectors located within the 50 or 75% ellipses, were considered to be in dry weight, so they did not require any fluid removal adjustment. However, participants with vectors outside the 75% ellipse were considered overhydrated or dehydrated and dry weight was adjusted. In these patients, if the vectors fell outside the 75% ellipse but within the 95%, above or below the major axis, the established dry weight was adjusted by 0.5 Kg. If the vectors fell outside the 95% ellipse, the weight was adjusted by 1.0 Kg.
Patients in both groups also received a personalized diet according to the recommendations of the KDOQI guidelines and the European best practice guidelines on nutrition: 35 Kcal /ideal body weight/day, 1.2 g protein/ideal body weight/day, Na <2000 mg/day, potassium <2000 mg/day, and P <1000 mg/day. Diets were planned and designed by trained renal dietitians and were given to the patients at the beginning of the study. To specify the adequate portion size, food models and photographs of utensils were used. Evaluation of food intake was performed monthly by a three-day food record in order to assess adherence.
- Being tested
- Proteinex and Enterex DBT Victus Laboratories, Dry weight adjustment through BIVA
- Keywords
- Dry weight, Undernutrition, Bioelectrical vector analysis, Oral nutrition supplementation, Quality of life
- Medical subject headings
- Water Intoxication, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteinex and Enterex DBT Victus LaboratoriesDietary supplement
The supplement was provided five days per week. Three days a week, the supplement was given at the beginning of the HD session and the patients were instructed to consume it slowly during the next 3 hours. The remaining two days, the supplement was consumed at home and instructed to be consumed between meals. The ONS consisted of one can of polymeric formula (Enterex DBT, Victus Laboratories) and 5.6 g of a protein powder supplement (Proteinex, Victus Laboratories). The final mixture provided 240 kcal, 17 g protein, 8.1 g lipids, 25 g carbohydrates, 4 g dietary fiber, 201 mg sodium, 490 mg calcium, 356 mg phosphorus and 371 mg potassium
Dry weight adjustment through BIVAProcedure or surgery
Those participants with post-dialysis vectors located within the 50 or 75% ellipses, were considered to be in dry weight, so they did not require any fluid removal adjustment. However, participants with vectors outside the 75% ellipse were considered overhydrated or dehydrated and dry weight was adjusted. In these patients, if the vectors fell outside the 75% ellipse but within the 95%, above or below the major axis, the established dry weight was adjusted by 0.5 Kg. If the vectors fell outside the 95% ellipse, the weight was adjusted by 1.0 Kg.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients in CON group received a personalized diet and dry weight adjustment by BIVA. Anthropometrical, biochemical, dietary, QoL, handgrip strength (HGS) and bioimpedance measurements were performed. Malnutrition Inflammation Score (MIS) was applied Receives: Procedure: Dry weight adjustment through BIVA |
| Supplemented | Experimental | Patients in SUPL group received a simultaneous intervention consisting of a personalized diet, 245 mL/d ONS and dry weight adjustment through BIVA, Anthropometrical, biochemical, dietary, QoL, handgrip strength (HGS) and bioimpedance measurements were performed. Malnutrition Inflammation Score (MIS) was applied Receives: Dietary Supplement: Proteinex and Enterex DBT Victus Laboratories; Procedure: Dry weight adjustment through BIVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nutritional status from baseline to 6 months
Nutritional status was assessed by the Malnutrition Inflammation Score (MIS). MIS is a 27 points maximum scale. According to the total score obtained, the following diagnoses were considered: normal nutritional status (0 points), mild undernutrition (1 - 9 points), moderate undernutrition (10 - 19 points) and severe undernutrition (> 20 points)
Measured: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention).
Change in hydration status from baseline to 6 months
Hydration status was evaluated by bioelectrical impedance vector analysis (BIVA). BIA was measured immediately before the start and ten minutes after the end of the mid-week HD session, by the same trained personnel. Individual resistance and reactance values were standardized by the height of each patient (R/H, Xc/H) and then plotted on the reference ellipses of the Mexican population.
Dehydration was considered when the vector was at the top, outside the 75% ellipses Overhydration was considered when the vector was at the bottom, outside the 75% ellipses Normohydration was considered when the vector was within the ellipses of 50 and 75%
Measured: Every week through study completion (six months).
Secondary outcomes (18)
Change in Quality of life evaluation (KDQOL SF) from baseline to 6 months
QoL was assessed using the Kidney Disease Quality of Life-Short Form (KDQOL-SF). The instrument includes 36 items. Responses were scored from 0 to 100 points, <50 points meant poor QoL. The higher the score (>50 points), the better QoL.
Measured: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention).
Change in hand grip strength (HGS) from baseline to 6 months
HGS was measured with a dynamometer on the non-fistula side after the HD session, three consecutive times, with a rest period of 1 minute between measurements and the highest value was recorded. Poor strength of the hand and forearm muscles were considered with <20 Kg and <30 Kg for women and men, respectively.
Measured: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Monthly change in gastrointestinal symptoms evaluation (GSQ) from baseline to 6 months
Gastrointestinal symptoms were assessed with the self-administered GI symptoms questionnaire (GSQ). The GSQ includes 8 items: anorexia, nausea, vomiting, heartburn, bloating, abdominal pain, constipation and diarrhea. Each symptom is rated between 1 to 5 points, and the higher the score, the more severe the symptoms
Measured: Every month through study completion (six months).
Monthly change in calorie intake from baseline to 6 months
Calorie intake was evaluated by a three-day food record. Patients were asked to record all foods consumed during three days in the same week (one dialysis day, one non-dialysis day, and one weekend day).Three-day food records were analyzed using a nutrient software program and reported as calories consumed per kilogram of weight
Measured: Every month through study completion (six months).
Monthly change in protein intake from baseline to 6 months
Protein intake was evaluated by a three-day food record. Patients were asked to record all foods consumed during three days in the same week (one dialysis day, one non-dialysis day, and one weekend day).Three-day food records were analyzed using a nutrient software program and reported as grams of protein consumed per kilogram of weight
Measured: Every month through study completion (six months).
Change in postdialysis weight from baseline to 6 months
Body weight was measured before and after all hemodialysis sessions during the six months of the intervention and reported in kilograms, according to the International Society for the Advancement of Kinanthropometry (ISAK) guidelines.
Measured: Three times a week in every hemodialysis session through study completion (six months).
Change in postdialysis body mass index from baseline to 6 months
Body mass index was calculated by dividing weight by height squared and reported as kilogram/meters2.
Measured: Every month through study completion (six months).
Change in arm muscle circumference from baseline to 6 months
Arm circumference and triceps skinfold (TSF) were measured at the end of the mid-week HD session according to the International Society for the Advancement of Kinanthropometry (ISAK) guidelines in triplicate by the same standardized dietitian.
Arm circumference was calculated usig the following formula: arm circumference (mm) - (3.1416 x triceps skinfold (mm)) and reported in mm
Measured: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting glucose from baseline to 6 months
Fasting blood samples were drawn from the vascular access of each participant before the start of the HD session. All tests were performed at the hospital´s clinical laboratory using certified methods.
Fasting glucose was determined by electric impedance and fluorescence and reported in mg/dl
Measured: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting urea from baseline to 6 months
Fasting blood samples were drawn from the vascular access of each participant before the start of the HD session. All tests were performed at the hospital´s clinical laboratory using certified methods.
Fasting urea was determined by electric impedance and fluorescence and reported in mg/dl
Measured: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting creatinine from baseline to 6 months
Fasting blood samples were drawn from the vascular access of each participant before the start of the HD session. All tests were performed at the hospital´s clinical laboratory using certified methods.
Fasting creatinine was determined by electric impedance and fluorescence and reported in mg/dl
Measured: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting phosphorus from baseline to 6 months
Fasting blood samples were drawn from the vascular access of each participant before the start of the HD session. All tests were performed at the hospital´s clinical laboratory using certified methods.
Fasting phosphorus was determined by electric impedance and fluorescence and reported in mg/dl
Measured: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting sodium from baseline to 6 months
Fasting blood samples were drawn from the vascular access of each participant before the start of the HD session. All tests were performed at the hospital´s clinical laboratory using certified methods.
Fasting sodium was determined by electric impedance and fluorescence and reported in mEq/L
Measured: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting potassium from baseline to 6 months
Fasting blood samples were drawn from the vascular access of each participant before the start of the HD session. All tests were performed at the hospital´s clinical laboratory using certified methods.
Fasting potassium was determined by electric impedance and fluorescence and reported in mEq/L
Measured: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting calcium from baseline to 6 months
Fasting blood samples were drawn from the vascular access of each participant before the start of the HD session. All tests were performed at the hospital´s clinical laboratory using certified methods.
Fasting calcium was determined by electric impedance and fluorescence and reported in mg/dL
Measured: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting albumin from baseline to 6 months
Fasting blood samples were drawn from the vascular access of each participant before the start of the HD session. All tests were performed at the hospital´s clinical laboratory using certified methods.
Fasting albumin was determined by electric impedance and fluorescence and reported in g/dL
Measured: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting transferrin from baseline to 6 months
Fasting blood samples were drawn from the vascular access of each participant before the start of the HD session. All tests were performed at the hospital´s clinical laboratory using certified methods.
Fasting transferrin was determined by chemiluminescence and reported in mg/dL
Measured: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting high-sensitivity C reactive protein from baseline to 6 months
Fasting blood samples were drawn from the vascular access of each participant before the start of the HD session. All tests were performed at the hospital´s clinical laboratory using certified methods.
Fasting high-sensitivity C reactive protein was determined by plate agglutination and reported in mg/dL
Measured: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Jan 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Requiring Chronic DialysisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thirty-two chronic HD patients were included in a 6-month randomized pilot study. Patients in SUPL group received a simultaneous intervention consisting of a personalized diet, 245 mL/d ONS and dry weight adjustment through BIVA. Patients in CON group received a personalized diet and dry weight adjustment by BIVA. Anthropometrical, biochemical, dietary, QoL, handgrip strength (HGS) and bioimpedance measurements were performed. Malnutrition Inflammation Score (MIS) was applied.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Queretaro
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Indiana University, Ball State University
- Responsible party
- Principal investigator, Iris del Carmen Nieves Anaya, Universidad Autonoma de Queretaro
- Investigators
- Ximena Atilano-Carsi, PhD, Study director, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288101
- Sponsor's protocol ID
- UAQ-ISSSTE-INCMNSZ-4423632676
- Status last verified
- Mar 2022
- First submitted
- 13 Dec 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nieves-Anaya I, Vargas MB, Mayorga H, Garcia OP, Colin-Ramirez E, Atilano-Carsi X. Comparison of nutritional and hydration status in patients undergoing twice and thrice-weekly hemodialysis: a silent drama in developing countries. Int Urol Nephrol. 2021 Mar;53(3):571-581. doi: 10.1007/s11255-020-02697-3. Epub 2021 Jan 4.
PubMed 33394280Ikizler TA, Cano NJ, Franch H, Fouque D, Himmelfarb J, Kalantar-Zadeh K, Kuhlmann MK, Stenvinkel P, TerWee P, Teta D, Wang AY, Wanner C; International Society of Renal Nutrition and Metabolism. Prevention and treatment of protein energy wasting in chronic kidney disease patients: a consensus statement by the International Society of Renal Nutrition and Metabolism. Kidney Int. 2013 Dec;84(6):1096-107. doi: 10.1038/ki.2013.147. Epub 2013 May 22.
PubMed 23698226Hanna RM, Ghobry L, Wassef O, Rhee CM, Kalantar-Zadeh K. A Practical Approach to Nutrition, Protein-Energy Wasting, Sarcopenia, and Cachexia in Patients with Chronic Kidney Disease. Blood Purif. 2020;49(1-2):202-211. doi: 10.1159/000504240. Epub 2019 Dec 18.
PubMed 31851983Kalantar-Zadeh K, Ikizler TA, Block G, Avram MM, Kopple JD. Malnutrition-inflammation complex syndrome in dialysis patients: causes and consequences. Am J Kidney Dis. 2003 Nov;42(5):864-81. doi: 10.1016/j.ajkd.2003.07.016.
PubMed 14582032Carrero JJ, Thomas F, Nagy K, Arogundade F, Avesani CM, Chan M, Chmielewski M, Cordeiro AC, Espinosa-Cuevas A, Fiaccadori E, Guebre-Egziabher F, Hand RK, Hung AM, Ikizler TA, Johansson LR, Kalantar-Zadeh K, Karupaiah T, Lindholm B, Marckmann P, Mafra D, Parekh RS, Park J, Russo S, Saxena A, Sezer S, Teta D, Ter Wee PM, Verseput C, Wang AYM, Xu H, Lu Y, Molnar MZ, Kovesdy CP. Global Prevalence of Protein-Energy Wasting in Kidney Disease: A Meta-analysis of Contemporary Observational Studies From the International Society of Renal Nutrition and Metabolism. J Ren Nutr. 2018 Nov;28(6):380-392. doi: 10.1053/j.jrn.2018.08.006.
PubMed 30348259Sabatino A, Regolisti G, Karupaiah T, Sahathevan S, Sadu Singh BK, Khor BH, Salhab N, Karavetian M, Cupisti A, Fiaccadori E. Protein-energy wasting and nutritional supplementation in patients with end-stage renal disease on hemodialysis. Clin Nutr. 2017 Jun;36(3):663-671. doi: 10.1016/j.clnu.2016.06.007. Epub 2016 Jun 18.
PubMed 27371993Pupim LB, Majchrzak KM, Flakoll PJ, Ikizler TA. Intradialytic oral nutrition improves protein homeostasis in chronic hemodialysis patients with deranged nutritional status. J Am Soc Nephrol. 2006 Nov;17(11):3149-57. doi: 10.1681/ASN.2006040413. Epub 2006 Oct 4.
PubMed 17021267Atilano-Carsi X, Miguel JL, Martinez Ara J, Sanchez Villanueva R, Gonzalez Garcia E, Selgas Gutierrez R. [Bioimpedance vector analysis as a tool for the determination and adjustment of dry weight in patients undergoing hemodialysis]. Nutr Hosp. 2015 May 1;31(5):2220-9. doi: 10.3305/nh.2015.31.5.8649. Spanish.
PubMed 25929397
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Nutritional Supplementation Combined With Impedance Vectors for Dry Weight Adjustment on the Nutritional Status, Hydration Status and Quality of Life in Patients on Chronic Hemodialysis: a Pilot Study
- ClinicalTrials.gov ID
- NCT05288101
- Acronym / sponsor ID
- UAQ-ISSSTE-INCMNSZ-4423632676
- Keywords
- Dry weight, Undernutrition, Bioelectrical vector analysis, Oral nutrition supplementation, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universidad Autonoma de QueretaroUniversity, hospital or other
- Collaborators
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Indiana University, Ball State University
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 18 Mar 2022 (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.
The objective of this study was to assess the effect of oral nutritional supplementation (ONS) combined with bioelectrical vector analysis (BIVA) on the nutritional and hydration status and the quality of life (QoL) in hemodialysis (HD) patients. Design and Methods: Thirty-two chronic HD patients were included in a 6-month randomized pilot study. Patients in SUPL group received a simultaneous intervention consisting of a personalized diet, 245 mL/d ONS and dry weight adjustment through BIVA. Patients in CON group received a personalized diet and dry weight adjustment by BIVA. Anthropometrical, biochemical, dietary, QoL, handgrip strength (HGS) and bioimpedance measurements were performed. Malnutrition Inflammation Score (MIS) was applied.
Detailed description
This was a randomized, controlled, pilot study. Due to the type of study, no sample size was calculated because the aim was to include all patients available . Patients were randomly assigned to one of two treatments: 1) simultaneous intervention of dry weight adjustment through BIVA, a personalized diet, and 245 mL/d of ONS (SUPL), or 2) dry weight adjustment by BIVA and a personalized diet (CON). Both treatments were given for six months All measurements were made in accordance with good clinical practice and the recommendations of the Helsinki Declaration on human studies. The protocol was registered and approved by the Ethics Committee of the Faculty of Natural Science of the Autonomous University of Queretaro (No. 252FCN2016) and by the Ethics Committee of the ISSSTE in Queretaro. All patients provided written informed consent to participate in this study.
The supplement was provided five days per week. Three days a week, the supplement was given at the beginning of the HD session and the patients were instructed to consume it slowly during the next 3 hours. The remaining two days, the supplement was consumed at home and instructed to be consumed between meals.
The ONS consisted of one can of polymeric formula (Enterex DBT, Victus Laboratories) and 5.6 g of a protein powder supplement (Proteinex, Victus Laboratories). The final mixture provided 240 kcal, 17 g protein, 8.1 g lipids, 25 g carbohydrates, 4 g dietary fiber, 201 mg sodium, 490 mg calcium, 356 mg phosphorus and 371 mg potassium. When the ONS was provided at the HD unit, the mixture was prepared at the hospital´s enteral mixing center and delivered to the patient in a plastic cup with lid and a straw. For the two remaining days, the patients were instructed about the mixture preparation and they were given two cans of supplement and two sealed plastic bags with 5.6 grams of protein powder each one. Adherence to supplement intake was determined by recording the number of servings consumed weekly. For this purpose, at the end of each HD session, the plastic cups were collected to ensure the total consumption of the supplement and for the ONS consumed at home, the patients were asked to return empty cans and plastic bags to the research staff.
Both groups received the intervention to adjust dry weight in order to reach normohydration. Those participants with post-dialysis vectors located within the 50 or 75% ellipses, were considered to be in dry weight, so they did not require any fluid removal adjustment. However, participants with vectors outside the 75% ellipse were considered overhydrated or dehydrated and dry weight was adjusted. In these patients, if the vectors fell outside the 75% ellipse but within the 95%, above or below the major axis, the established dry weight was adjusted by 0.5 Kg. If the vectors fell outside the 95% ellipse, the weight was adjusted by 1.0 Kg.
Patients in both groups also received a personalized diet according to the recommendations of the KDOQI guidelines and the European best practice guidelines on nutrition: 35 Kcal /ideal body weight/day, 1.2 g protein/ideal body weight/day, Na <2000 mg/day, potassium <2000 mg/day, and P <1000 mg/day. Diets were planned and designed by trained renal dietitians and were given to the patients at the beginning of the study. To specify the adequate portion size, food models and photographs of utensils were used. Evaluation of food intake was performed monthly by a three-day food record in order to assess adherence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Thirty-two chronic HD patients were included in a 6-month randomized pilot study. Patients in SUPL group received a simultaneous intervention consisting of a personalized diet, 245 mL/d ONS and dry weight adjustment through BIVA. Patients in CON group received a personalized diet and dry weight adjustment by BIVA. Anthropometrical, biochemical, dietary, QoL, handgrip strength (HGS) and bioimpedance measurements were performed. Malnutrition Inflammation Score (MIS) was applied.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Dry weight adjustment through BIVAPatients in CON group received a personalized diet and dry weight adjustment by BIVA. Anthropometrical, biochemical, dietary, QoL, handgrip strength (HGS) and bioimpedance measurements were performed. Malnutrition Inflammation Score (MIS) was applied |
| Supplemented | Experimental | Dietary Supplement: Proteinex and Enterex DBT Victus Laboratories, Procedure: Dry weight adjustment through BIVAPatients in SUPL group received a simultaneous intervention consisting of a personalized diet, 245 mL/d ONS and dry weight adjustment through BIVA, Anthropometrical, biochemical, dietary, QoL, handgrip strength (HGS) and bioimpedance measurements were performed. Malnutrition Inflammation Score (MIS) was applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients on chronic HD undergoing thrice weekly hemodialysis (at least three hours per treatment) for more than three months were included.
Key exclusion criteria (1 listed)
- Patients with amputations of any limb, metal implants, diagnosis of dementia, or current consumption of nutritional supplements were excluded.
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 |
|---|---|---|
| Proteinex and Enterex DBT Victus LaboratoriesThe supplement was provided five days per week. Three days a week, the supplement was given at the beginning of the HD session and the patients were instructed to consume it slowly during the next 3 hours. The remaining two days, the supplement was consumed at home and instructed to be consumed between meals. The ONS consisted of one can of polymeric formula (Enterex DBT, Victus Laboratories) and 5.6 g of a protein powder supplement (Proteinex, Victus Laboratories). The final mixture provided 240 kcal, 17 g protein, 8.1 g lipids, 25 g carbohydrates, 4 g dietary fiber, 201 mg sodium, 490 mg calcium, 356 mg phosphorus and 371 mg potassium | Dietary supplement | Supplemented |
| Dry weight adjustment through BIVAThose participants with post-dialysis vectors located within the 50 or 75% ellipses, were considered to be in dry weight, so they did not require any fluid removal adjustment. However, participants with vectors outside the 75% ellipse were considered overhydrated or dehydrated and dry weight was adjusted. In these patients, if the vectors fell outside the 75% ellipse but within the 95%, above or below the major axis, the established dry weight was adjusted by 0.5 Kg. If the vectors fell outside the 95% ellipse, the weight was adjusted by 1.0 Kg. | Procedure or surgery | Control, Supplemented |
Primary outcome
Change in nutritional status from baseline to 6 months
Time frame: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention).
Nutritional status was assessed by the Malnutrition Inflammation Score (MIS). MIS is a 27 points maximum scale. According to the total score obtained, the following diagnoses were considered: normal nutritional status (0 points), mild undernutrition (1 - 9 points), moderate undernutrition (10 - 19 points) and severe undernutrition (> 20 points)
Change in hydration status from baseline to 6 months
Time frame: Every week through study completion (six months).
Hydration status was evaluated by bioelectrical impedance vector analysis (BIVA). BIA was measured immediately before the start and ten minutes after the end of the mid-week HD session, by the same trained personnel. Individual resistance and reactance values were standardized by the height of each patient (R/H, Xc/H) and then plotted on the reference ellipses of the Mexican population. Dehydration was considered when the vector was at the top, outside the 75% ellipses Overhydration was considered when the vector was at the bottom, outside the 75% ellipses Normohydration was considered when the vector was within the ellipses of 50 and 75%
18 secondary outcomes
Change in Quality of life evaluation (KDQOL SF) from baseline to 6 months
Time frame: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention).
Change in hand grip strength (HGS) from baseline to 6 months
Time frame: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Monthly change in gastrointestinal symptoms evaluation (GSQ) from baseline to 6 months
Time frame: Every month through study completion (six months).
Monthly change in calorie intake from baseline to 6 months
Time frame: Every month through study completion (six months).
Monthly change in protein intake from baseline to 6 months
Time frame: Every month through study completion (six months).
Change in postdialysis weight from baseline to 6 months
Time frame: Three times a week in every hemodialysis session through study completion (six months).
Change in postdialysis body mass index from baseline to 6 months
Time frame: Every month through study completion (six months).
Change in arm muscle circumference from baseline to 6 months
Time frame: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting glucose from baseline to 6 months
Time frame: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting urea from baseline to 6 months
Time frame: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting creatinine from baseline to 6 months
Time frame: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting phosphorus from baseline to 6 months
Time frame: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting sodium from baseline to 6 months
Time frame: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting potassium from baseline to 6 months
Time frame: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting calcium from baseline to 6 months
Time frame: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting albumin from baseline to 6 months
Time frame: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting transferrin from baseline to 6 months
Time frame: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Change in fasting high-sensitivity C reactive protein from baseline to 6 months
Time frame: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Background: PubMed 33394280Nieves-Anaya I, Vargas MB, Mayorga H, Garcia OP, Colin-Ramirez E, Atilano-Carsi X. Comparison of nutritional and hydration status in patients undergoing twice and thrice-weekly hemodialysis: a silent drama in developing countries. Int Urol Nephrol. 2021 Mar;53(3):571-581. doi: 10.1007/s11255-020-02697-3. Epub 2021 Jan 4.
- Results publication: PubMed 23698226Ikizler TA, Cano NJ, Franch H, Fouque D, Himmelfarb J, Kalantar-Zadeh K, Kuhlmann MK, Stenvinkel P, TerWee P, Teta D, Wang AY, Wanner C; International Society of Renal Nutrition and Metabolism. Prevention and treatment of protein energy wasting in chronic kidney disease patients: a consensus statement by the International Society of Renal Nutrition and Metabolism. Kidney Int. 2013 Dec;84(6):1096-107. doi: 10.1038/ki.2013.147. Epub 2013 May 22.
- Results publication: PubMed 31851983Hanna RM, Ghobry L, Wassef O, Rhee CM, Kalantar-Zadeh K. A Practical Approach to Nutrition, Protein-Energy Wasting, Sarcopenia, and Cachexia in Patients with Chronic Kidney Disease. Blood Purif. 2020;49(1-2):202-211. doi: 10.1159/000504240. Epub 2019 Dec 18.
- Results publication: PubMed 14582032Kalantar-Zadeh K, Ikizler TA, Block G, Avram MM, Kopple JD. Malnutrition-inflammation complex syndrome in dialysis patients: causes and consequences. Am J Kidney Dis. 2003 Nov;42(5):864-81. doi: 10.1016/j.ajkd.2003.07.016.
- Results publication: PubMed 30348259Carrero JJ, Thomas F, Nagy K, Arogundade F, Avesani CM, Chan M, Chmielewski M, Cordeiro AC, Espinosa-Cuevas A, Fiaccadori E, Guebre-Egziabher F, Hand RK, Hung AM, Ikizler TA, Johansson LR, Kalantar-Zadeh K, Karupaiah T, Lindholm B, Marckmann P, Mafra D, Parekh RS, Park J, Russo S, Saxena A, Sezer S, Teta D, Ter Wee PM, Verseput C, Wang AYM, Xu H, Lu Y, Molnar MZ, Kovesdy CP. Global Prevalence of Protein-Energy Wasting in Kidney Disease: A Meta-analysis of Contemporary Observational Studies From the International Society of Renal Nutrition and Metabolism. J Ren Nutr. 2018 Nov;28(6):380-392. doi: 10.1053/j.jrn.2018.08.006.
- Results publication: PubMed 27371993Sabatino A, Regolisti G, Karupaiah T, Sahathevan S, Sadu Singh BK, Khor BH, Salhab N, Karavetian M, Cupisti A, Fiaccadori E. Protein-energy wasting and nutritional supplementation in patients with end-stage renal disease on hemodialysis. Clin Nutr. 2017 Jun;36(3):663-671. doi: 10.1016/j.clnu.2016.06.007. Epub 2016 Jun 18.
- Results publication: PubMed 17021267Pupim LB, Majchrzak KM, Flakoll PJ, Ikizler TA. Intradialytic oral nutrition improves protein homeostasis in chronic hemodialysis patients with deranged nutritional status. J Am Soc Nephrol. 2006 Nov;17(11):3149-57. doi: 10.1681/ASN.2006040413. Epub 2006 Oct 4.
- Results publication: PubMed 25929397Atilano-Carsi X, Miguel JL, Martinez Ara J, Sanchez Villanueva R, Gonzalez Garcia E, Selgas Gutierrez R. [Bioimpedance vector analysis as a tool for the determination and adjustment of dry weight in patients undergoing hemodialysis]. Nutr Hosp. 2015 May 1;31(5):2220-9. doi: 10.3305/nh.2015.31.5.8649. Spanish.
- 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. This study is not recruiting at the moment.
Ximena Atilano-Carsi, PhD study director
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proteinex and Enterex DBT Victus Laboratories and Dry weight adjustment through BIVA in people with Chronic Kidney Disease Requiring Chronic Dialysis and Overhydration, run by Universidad Autonoma de Queretaro 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nutritional status from baseline to 6 months (time frame: At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention).). 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 NCT05288101, which also lists 8 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 Mar 2022.