Effectiveness And Safety Of Formulated Foods In The Treatment Of Nonalcoholic Fatty Liver Disease

Background:Prebiotics and dietary fiber can improve nonalcoholic fatty liver disease by changing the intestinal flora and its metabolites.This study mainly explored the effectiveness and safety of formulated foods for the treatment of nonalcoholic fatty liver disease.Methods:Twenty-four patients with non-alcoholic fatty liver disease were recruited and randomly divided into a formulated foods group(n=16)and a placebo group(n=8)at a ratio of 2:1.Both groups will receive the same lifestyle and dietary recommendations.MRS-PDFF was used to quantitatively determine liver fat content;liver function,glucose metabolism,and lipid metabolism were measured using a fully automatic analysis biochemical instrument,and HOMA-IR was calculated;using ELISA reagents to detects the level of CK18;the subject's anthropological indicators are measured,and the BMI is calculated.Changes in MRS-PDFF,anthropological indicators,liver function,blood glucose,blood lipids,and blood uric acid were evaluated for effectiveness.During the follow-up,blood routine,renal function,12-lead ECG,and adverse reactions were evaluated for safety.Results:1.MRS-PDFF:The baseline of MRS-PDFF between the experimental group and the placebo group was no statistical difference(P=0.76).At the end of treatment,the MRS-PDFF in the test group decreased from 18.23±6.62%to 10.14±7.35%,P=0.022.Placebo group was no difference(P>0.05).The difference between two groups was remarkably(P=0.046).The decrease was more significant in the test group(-8.09±2.19%vs 0.18±1.26%,P=0.018).The reduction of MRS-PDFF by more than 30%in the treatment group was 66.7%,as for the placebo group was 14.3%;the final MRS-PDFF in the treatment group was 40%while placebo group was 14.3%.Comparison of CAP values found that after 24 weeks of treatment,the treatment decreased from 339.6±33.7d B/m to 270.8±68.1d B/m,P=0.01.And the placebo group decreased from338.0±45.3d B/m to 271.0±42.5d B/m,P=0.003.However,there was no significant difference between the groups and the absolute value of the decrease between the two groups after 24 weeks(P=0.996;P=0.503).2.Anthropological indexes:The baseline of body weight,BMI,and waist circumference between the experimental group and the placebo group were no statistical difference(P>0.05).At the end of treatment,the body weight,BMI,and waist circumference of the treatment group decreased remarkably.The average weight loss was 5.1%(82.7±13.9 kg to 78.5±15.5 kg,P=0.02),and33.3%of the subjects lost more than 7%.BMI decreased by 5.4%(29.8±3.8kg/m~2 to28.2±4.2kg/m~2,P=0.025),and waist circumference decreased by 4.3%(97.4±9.9cm decreased to 93.2±11.1cm,P=0.009).No difference in placebo group(P>0.05).Between two groups,body weight had a difference(P=0.037),BMI and waist circumference were no difference(P>0.05).3.Liver function and uric acid:The baseline of ALT,AST,GGT,and uric acid between the experimental group and the placebo group were no statistical difference(P>0.05).At the end of treatment,ALT,AST,GGT,and uric acid in the experimental group all decreased remarkably(ALT:127.5±59.0 U/L to 53.5±37.3 U/L,P=0.01;AST:62.27±21.67U/L to 32.47±17.95U/L,P<0.001;GGT:88.80U/L±55.87U/L to 51.61±39.16U/L,P<0.001;UA:465.3±83.9?mol/L to 426.1±94.1?mol/L,P=0.022).Difference in the placebo group wasn't remarkably(P>0.05).The decrease in AST and GGT was more significant in the experimental group compared with placebo group(AST:-29.8±6.19U/L vs-2.57±9.6U/L,P=0.029;GGT:37.12±8.41U/L vs 0.86±16.3U/L,P=0.031).The Difference between two groups wasn't remarkably(P>0.05).4.Blood lipids:The baseline of TC,TG,HDL and LDL between the experimental group and the placebo group were no statistical difference(P>0.05).After 24 weeks of treatment,HDL in the experimental group increased strikingly,from 1.1±0.2mmol/L to 1.2±0.2mmol/L,P=0.01.LDL in the placebo group increased markedly,from 2.91±0.33mmol/L to 3.30±0.34mmol/L,P=0.01.TC,TG,HDL and LDL had no difference between two groups(P>0.05).5.Glucose metabolism and serum CK18:The baseline of FBG,Hb A1c,HOMA-IR,and CK18 between the experimental group and the placebo group were no statistical difference(P>0.05).And the FBG,Hb A1c,HOMA-IR,and CK18 in the experimental group and placebo group were not statistically different within and between groups after 24 weeks of treatment(P>0.05).6.Safety analysis:Blood routine,urine routine and conventional ECG were almost normal between the experimental group and the placebo group during follow-up.And there was one case of dry stool in the test group and an increase in the number of defecations.The placebo group didn't have adverse effects.Conclusion:At the end of treatment,formulas rich in fructooligosaccharides and resistant dextrin can reduce liver fat content and weight in patients with non-alcoholic steatohepatitis,as well as improve liver function and lower serum uric acid.Adverse reactions were consistent with the placebo group.