The Effects Of Oral Energy Supplements On Nutritional Status And Quality Of Life In Maintenance Hemodialysis Patients

Background:Several studies have found that the patients on maintenance hemodialysis(MHD)have inadequate dietary energy intake induced by anorexia,inflammation,poor gastrointestinal function and dietary restriction.A frequent and important cause of poor nutritional status in MHD patients is inadequate dietary protein and energy intake.The guidelines from the Kidney Disease Outcome Quality Initiative recommend a daily dietary energy intake(DEI)of 35 kcal/kg body weight/d for MHD patients who are less than 60 years of age and a DEI of 30 to 35 kcal/kg body weight/d for those 60 years of age or older.However,several previous studies have found that MHD patients tend to have low DEI.Our previous cohort study showed that the DEI of MHD patients in China was lower than the guidelines recommended.Low dietary energy intake was a risk factor for all-cause mortality and cardiovascular related mortality.Nutritional support for MHD patients is an effective way in replenishing energy.Evidences regarding to the effects of oral nutritional supplements on nutritional status and quality of life are limited and inconsistent.So far,no studies were conducted to test the effects of oral energy supplements sourced from fat on the nutritional status and quality of life in MHD patients.Objective:The aim of this study was to investigate the effects of oral energy supplements on the nutritional status and quality of life in MHD patients with inadequate energy intake in a multicenter,open label,randomized controlled trial.Methods:This was a multicenter,open label,randomized,controlled trial in MHD patients in China(ChiCTR1800015068).In all,240 MHD patients with DEI<30kcal/kg/d,on MHD for at least 3 months and have a normal oral intake were recruited from five outpatients hemodialysis centers in Guangdong province from March 2018 to December 2018.These patients were selected from a total of 1078 subjects.The study was approved by the Medical Ethics Committee of Nanfang Hospital and all the participants provided written consent.Data including demographic characteristics,history of disease,the use of medicines,the dietary survey(including one dialysis day,two non-dialysis days),physical examinations(including body mass index,midarm circumference,triceps skinfold,waist,hip and grip),body composition(body composition was determined by body impedance analysis,including phase angel,fat mass and muscle mass),laboratory indicators,the quality of life were collected at baseline by trained research staff according to standard operating procedures.Patients were randomly assigned to either the intervention group or the control group.To achieve a balance between these two groups,permuted fixed-block randomization with a block length of four was used.Patients in the intervention group were instructed to take 60ml of the oral nutritional supplementation(with high energy-density,5kcal/ml energy,are protein-free and contains very low sucrose,vitamin E,vitamin K1 and cellulose and the energy sourced from fat)for 12 weeks,whereas,the patients in the control group did not receive any intervention.Dietary advice was provided to both groups.During the study,the participants were not allowed to receive other nutritional intervention.Participants were followed up every 6 weeks,and at each visit,the outcomes were collected.Adverse event and tolerance were also recorded.The primary outcome of interest of this study was the rate of change in phase angel(PhA),which was defined as the ratio of change in PhA to baseline.PhA is assumed to indicate cell integrity and shows a good correlation with other nutritional parameters.The second parameters were rate of change of other nutritional parameters(included serum albumin,prealbumin,transferrin albumin,cholesterol,BMI,grip,triceps skinfold and Mid-arm muscle circumference)and the change of the quality of life.The rate of change was presented as median(Q1,Q3).Results:From March 2018 through December 2018,a total of 1078 patients were screened and 240 patients with DEI<30kcal/kg/d underwent randomization at 5centers.Of 240 subjects,54.6%were men with a mean age of 46.6 years old.The median duration of dialysis was 43.4(22.5,76.32)months.Participants in each group were well balanced at baseline with regard to relevant demographic and clinical characteristics.The results showed that the rate of change of PhA was-0.31(-4.07,5.65)in control group and-0.37(-5.57,5.55)in intervention group.There was no significant difference between these two groups(P=0.711).The intervention group had a higher rate of change of BMI than the control group(0.00(-1.06,1.01)vs.0.50(-0.82,2.11),P=0.045).The rate of change in albumin were-2.2(-5.00,2.20)and 0.50(-4.00,5.50)in control group and intervention group,respectively.The rate of change of albumin in intervention group was significantly higher than in control group(P=0.009).However,no significant differences were observed in prealbumin and transferrin albumin between these two groups.And there was no significant difference in triglycerides,total cholesterol,and serum phosphorus between the two groups.Besides,the results showed significant improvement in sleeping of the KDQOL-SF scale,but there were no differences in the other items.The change at 12weeks from baseline in sleeping score were 0.00(-10.00,7.50)and 2.50(-7.50,12.50)in control group and intervention group.The change of sleep score in intervention group was significantly higher than in control group(P=0.032).Conclusion:The nutritional status of MHD patients with inadequate dietary energy intake could be improved by oral energy supplements sourced from fat.Moreover,the sleeping score could be improved in intervention group.