Effect of Oral Nutritional Supplementation Combined With Impedance Vectors

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Kidney Disease Requiring Chronic Dialysis, Overhydration, Undernutrition

Intervention / Treatment
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* Dietary Supplement: Proteinex and Enterex DBT Victus Laboratories
* Procedure: Dry weight adjustment through BIVA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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 | Procedure: Dry weight adjustment through BIVA<br>* 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.<br>|
| Experimental: Supplemented<br>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 | Dietary Supplement: Proteinex and Enterex DBT Victus Laboratories<br>* 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<br>Procedure: Dry weight adjustment through BIVA<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| 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) | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry weight, Undernutrition, Bioelectrical vector analysis, Oral nutrition supplementation, Quality of life