| ObjectiveOvcrweight/obesity has become a global chronic disease that seriously harms human heal th,and dietary restriction is one of its basic treatments.Fasting-mimicking diet(FMD)i s an intermittent fasting model created by Professor Longo of the University of Southern California.We combined this fasting model with the theory of traditional Chinese medicine,developing a FMD comh ined wi th a "Cleari ng Dampness" meal package,then designed a clinical trial to evaluate its safety and effectiveness for phlegm-dampness type overweight/obesity patients.MethodsThe study used a randomized controlled trial method.From May 22,2019 to June 15,2019,60 phlegm-dampness type overweight/obesity subjects were included and were randomly assigned to "clearing dampness" FMD group,FMD group and normal diet group,wi th 20 people in each group.From July 1,2019 to September 29,2019,the subjects form three group performed their corresponding meal mode for three cycles(every 4 weeks in a cycle,12 weeks in total),that is the subjects in "clearing dampness" FMD group performed the meal mode which combined FMD with "clearing dampness" meal package,the subjects in FMD group performed the meal mode which combined FMD with "usual grain"meal package and the subjects in normal diet group keep a normal diet.To evaluate the efficacy of FMD combined with "clearing dampness" meal package and FMD in phlegm-dampness type overweight/obesity patients and the di fference between these two fasting mode,statitical analysis were performed to analysis the changes before and after the interventions in body morphology-related indicators,including body weight,body mass index,waist circumference,body fat percentage and skeletal muscle weight,and cardiovascular disease-related risk factors,including blood pressure,fasting blood glucose and blood lipids.Results1.A total of 60 subjects meeting the criteria were included,and 2 cases fell off in the end of the study,including 1 case in the "clearing dampness"FMD group and 1 case in FMD group.So a total of 58 cases were finally included in the statistical analysis.There was no statistical significance in the baseline data among three groups,including gender,age,weight,body mass index,body fat percentage,blood lipids,fasting blood glucose and blood pressure,except the body fat percentage between the FMD group and the normal diet group,which illustrated that the data was comparable..2.After three cycles of intervention,the comparison within each group illustrated the results as followed:2.1 Compared with baseline data,19 subjects in the "clearing dampness"FMD group had changes in body weight(-6.23±3.06,P<0.001),BMI(-2.29±1.06,P<0.001),waist circumference(-8.15±6.14,P<0.001),percentage of body fat(-4.14 ± 2.14,P<0.001),skeletal muscle weight(-0.46 ± 0.89,P=0.036),systolic blood pressure(-10.74±16.39,P=0.011),diastolic blood pressure(-7.11±8.91,P=0.003)and triglycerides(-0.34±0.53,P=0.014),and all showed a downward trend.The difference was statistically significant,suggesting that the FMD combined with "clearing dampness" meal packs is beneficial to phlegm-dampness type patients in regulation of body weight,BMI,waist circumference,body fat percentage,systolic blood pressure,diastolic blood pressure and triglyceride,but at the same time will cause skeletal muscle consumption.At the same time,after intervention,fasting blood glucose,total cholesterol and low-density lipoprotein showed a downward trend,and high-density lipoprotein showed an upward trend,but P>0.05,and the difference was not statistically significant.2.2 Compared with baseline data,19 subjects in the FMD group had changes in body weight(-5.07±3.36,P<0.001),BMI(-1.96±1.15,P<0.001),waist circumference(-5.23±5.56,P<0.001),percentage of body fat(-4.02±3.25,P<0.001),skeletal muscle weight(-0.53±0.70,P=0.004)and triglycerides(-0.30±0.53,P=0.027),and all showed a downward trend.The difference was statistically significant,suggesting that the FMD combined with "usual grains" meal packs is beneficial to phlegm-dampness type patients in regulation of body weight,BMI,waist circumference,body fat percentage and triglyceride,but at the same time will cause skeletal muscle consumption.At the same time,after intervention,systolic blood pressure,diastolic blood pressure,fasting blood glucose,total cholesterol and low-density lipoprotein showed a downward trend,and high-density lipoprotein showed an upward trend,but P>0.05,and the difference was not statistically signi ficant.2.3 Compared with basel ine data,20 subjects in the normal diet group had changes in body weight(-1.78±2.90,P=0.013),BMI(-0.66±1.04,P=0.010),waist circumference(-2.85±5.18,P=0.024),percentage of body fat(-1.57±2.14,P=0.004),and all showed a downward trend.The difference was stat istically significant,suggesting that the normal diet is also beneficial to phlegm-dampness type patients in regulation of body weight,BMI,waist circumference and body fat percentage.At the same time,after intervention,systolic blood pressure,diastolic blood pressure,fasting blood glucose,total cholesterol,and low-density lipoprotein showed a downward trend,while skeletal muscle weight,triglyceride,and high-densi ty lipoprotein showed an upward trend.,but P>0.05,and the difference was not statistical ly significant.3.After throe cycles of intervention,the comparison between the three groups illustrated the results as followed:3.1 There was statistical significance between the "clearing dampness"FMD group and the normal diet group in the following indicators:change in body weight(-4.45±1.00,P<0.001),change in BMI(-1.63±0.35,P<0.001),change in body fat percentage(-2.57±0.82,P=0.003),change in waist circumference(-5.84±2.01,P=0.006),changes in triglycerides(-0.39 ±0.18,P=0.032)and changes in diastol ic blood pressure(-5.32 ± 2.53,P=0.040),and the "clearing dampness" FMD group has an advantage,indicating that the FMD combined with,clearing dampness" meal package is more helpful than the normal diet in the control in weight BMI,body fat percentage,waist circumference,triglycerides and diastolic blood pressure.And the change of skeletal muscle weight(-0.54±0·23,P=0.021)is also statistical ly significant,but the "clearing dampness" FMD group is at a disadvantage,indicating that the FMD combined with "clearing dampness" meal package is may consume skeletal muscle weight.The total cholesterol,low-density lipoprotein cholesterol,high-density lipoprotein cholesterol,systolic blood pressure,and fasting blood glucose change values were not statistically significant between the two groups,and could not explain the difference in the regulation of the above two groups on the above indicators.3.2 There was statistical significance between the FMD group and the normal diet group in the following indicators:change in body weight(-3.23±1.00,P=0.002),change in BMI change(-1.30±0.35,P<0.001)and change in body fat percentage change(-2.45±0.82,P=0.004),and the FMD group has an advantage,indicating that the FMD combined with "usual grains" meal package is more helpful than the normal diet in the control in weight,BMI and body fat percentage.And the change of skeletal muscle weight(-0.61±0.23,P=0.010)is also statistically significant,but the FMD group is at a disadvantage,indicating that the FMD combined with "usual grains" meal package is may consume skeletal muscle weight.The blood lipids,blood pressure and fasting blood glucose change values were not statistically significant between the two groups,and could not explain the difference in the regulation of the above two groups on the above indicators.3.3 There was statistical significance between the "clearing dampness"FMD group and the normal diet group in diastolic blood pressure(-6.16±2.53,P=0.018),and the "clearing dampness" FMD group had an advantage,indicating the FMD combined with "clearing dampness" meal package is more helpful than the FMD combined with "usual grains" meal package to lower the diastolic blood pressure.weight,BMI,body fat percentage,skeletal muscle weight,waist circumference,total cholesterol,triglycerides,low density lipoprotein cholesterol,high density lipoprotein cholesterol,systolic blood pressure and fasting blood glucose change values were not statistically significant between the two groups,and could not explain the difference in the regulation of the above two groups on the above indicators.3.4 Comparison of some indicators related to risk factors of cardiovascular and cerebrovascular diseases before and after intervention among the three groups:difference in systolic pressure,difference in diastolic pressure,difference in fasting blood glucose,difference in TG,difference in TC,difference in LDL-c between the three groups There was no statistically significant difference in the value and HDL-c difference(P>0.05),which could not explain the difference in the regulation effect of the three groups on blood pressure,blood glucose and blood lipid.4.Part of the research process,the subjects in the "clearing dampness"FMD group and the FMD group reported different levels of discomfort such as lightness,hunger,fatigue,dry stools,and no serious adverse events such as hypoglycemic reactions.Symptoms can be relieved after symptomatic treatment.ConclusionIt has been deduced through cl inical trials:FMD combined with "clearing dampness" meal package and FMD combined with" usual grains" meal package have a positive effect on control l ing weight,BMI,body fat percentage,waist and triglyceride in phlegm-dampness type overweight/obesity subjects,while FMD combined with "clearing dampness" meal package may have advantages in control ling diastolic blood pressure and triglyceride.There is no obvious advantage in the regulation of total cholesterol,low-density lipoprotein cholesterol,high-density lipoprotein cholesterol,systolic blood pressure and fasting blood glucose in these two modes.Normal diet are also beneficial to the target population to control body weight,BM1,waist circumference,and body fat percentage,but calorie restriction diet have more obvious effects on body morphology than normal diet programs.There were no signi ficant differences during three modes in the regulation of some risk factors for cardiovascular and cerebrovascular diseases such as blood pressure,blood glucose,and blood lipids.However,due to the small sample size and limited research duration of this study,larger cl inical studies are needed to further verify the accuracy of the conclusions. |
