Undernutrition Clinical Trial
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
Verified date | March 2022 |
Source | Universidad Autonoma de Queretaro |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | June 30, 2017 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients on chronic HD undergoing thrice weekly hemodialysis (at least three hours per treatment) for more than three months were included. Exclusion Criteria: - Patients with amputations of any limb, metal implants, diagnosis of dementia, or current consumption of nutritional supplements were excluded. |
Country | Name | City | State |
---|---|---|---|
Mexico | HD unit of the Social Security Institute for Government Employees (ISSSTE as per initials in Spanish | Queretaro |
Lead Sponsor | Collaborator |
---|---|
Universidad Autonoma de Queretaro | Ball State University, Indiana University School of Medicine, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Mexico,
Atilano-Carsi X, Miguel JL, Martínez Ara J, Sánchez Villanueva R, González García E, Selgas Gutiérrez R. [Bioimpedance vector analysis as a tool for the determination and adjustment of dry weight in patients undergoing hemodialysis]. Nutr Hosp. 2015 May 1 — View Citation
Carrero 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, P — View Citation
Hanna 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 — View Citation
Ikizler 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 — View Citation
Kalantar-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. Review. — View Citation
Nieves-Anaya I, Várgas MB, Mayorga H, García OP, Colín-Ramírez 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. — View Citation
Pupim 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. Epub 2006 Oct 4. — View Citation
Sabatino 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 J — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention). | |
Primary | 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% |
Every week through study completion (six months). | |
Secondary | 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. | At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention). | |
Secondary | 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. | At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention) | |
Secondary | 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 | Every month through study completion (six months). | |
Secondary | 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 | Every month through study completion (six months). | |
Secondary | 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 | Every month through study completion (six months). | |
Secondary | 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. | Three times a week in every hemodialysis session through study completion (six months). | |
Secondary | 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. | Every month through study completion (six months). | |
Secondary | 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 |
At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention) | |
Secondary | 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 |
At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention) | |
Secondary | 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 |
At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention) | |
Secondary | 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 |
At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention) | |
Secondary | 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 |
At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention) | |
Secondary | 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 |
At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention) | |
Secondary | 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 |
At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention) | |
Secondary | 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 |
At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention) | |
Secondary | 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 |
At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention) | |
Secondary | 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 |
At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention) | |
Secondary | 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 |
At the beginning of the study (baseline) and at the end of the intervention (six months after starting the intervention) |
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