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Effects of whey protein complex combined with low-intensity exercise in elderly inpatients with COPD at a stable stage.
Zong, M, Shen, H, Ren, L, Han, T, Chen, J, Chen, Y, Lu, J, Zhang, Y, Li, S, Sun, J
Asia Pacific journal of clinical nutrition. 2023;(4):375-382
Abstract
BACKGROUND AND OBJECTIVES Previous literature mostly has demonstrated the efficacy of pulmonary rehabilitation (PR) combined with whole nutrition powder in patients with chronic obstructive pulmonary disease (COPD). However, the benefits of whey protein as an oral nutritional supplement (ONS) during PR are not clear. METHODS AND STUDY DESIGN It took 12 weeks to complete the trial, we divided 90 elderly patients with stable-stage COPD into a low-intensity exercise group (n= 30, PR group), PR plus whey proteins complex group (n= 30, PRWP group), and a control group (n= 30) randomly, and assessed index such as exercise capacity, mental health status, lung function, and body composition. Eventually, 84 people persisted until the end of the trial. RESULTS Compared with the control group, hand grip strength (HGS)(1.4 ± 0.6 kg, and 1.0 ± 0.2 kg respectively, p< 0.05) in the PRWP and PR group, 6 minutes of walking distance (6MWD)(14.1 ± 3.8m, p< 0.05) in PRWP group improved. Furthermore, compared with the PR group, Medical Research Council Dyspnea Scale (MRC)(-0.2 ± 0.1, p< 0.01), anxiety score (-1.2 ± 0.4, p< 0.01), and body weight (2.0 ± 0.8kg, p< 0.05) improved in the PRWP group. There were no inter-group differences in a fat-free mass index or appendicular skeletal muscle mass index. CONCLUSIONS Muscle strength could be enhanced in both intervention models. Adding whey protein complex was additionally successful in rectifying dyspnea, anxiety, and weight loss caused by exercise. This rehabilitation pattern might be valuable in elderly patients with COPD.
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Effects of a Dulaglutide plus Calorie-Restricted Diet versus a Calorie-Restricted Diet on Visceral Fat and Metabolic Profiles in Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial.
Zhang, Y, Qu, Z, Lu, T, Shao, X, Cai, M, Dilimulati, D, Gao, X, Mao, W, Hu, F, Su, L, et al
Nutrients. 2023;15(3)
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Polycystic ovary syndrome (PCOS) is a unification of reproductive endocrine and metabolic disorders. Lifestyle and weight management, particularly dietary intake aimed at weight loss, are initial treatment strategies for PCOS. A calorie-restricted diet (CRD) seems to be the optimal dietary pattern for weight management in the PCOS population. The aim of this study was to evaluate modifications in fat distribution, the androgenic state, and metabolic profiles in the overweight and obese PCOS-affected population, who obtained modest and equivalent weight loss induced by a CRD regimen with or without Dulaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist (RA). This study was a randomised controlled trial which enrolled 68 females diagnosed with PCOS. Participants were randomly assigned to receive to one of the two groups: a GLP-1 RA combined with CRD or CRD alone. Results showed that participants in the GLP-1 RA + CRD group took a shorter time to achieve a 7% weight loss goal than those in the CRD group. Furthermore, both interventions had similar positive effects in improving menstrual frequency and reducing levels of blood pressure, insulin, aminotransferases, lipids, total fat mass, total lean mass, and abdominal subcutaneous adipose tissue mass after equivalent weight loss. Authors conclude that their findings support the importance of dietary intervention as a first-line treatment in women with PCOS, and that GLP-1 RA therapy offers an effective and generally tolerable adjunct therapy to aid in achieving weight targets based on dietary therapy in overweight and obese women with PCOS.
Abstract
The effects of dulaglutide and a calorie-restricted diet (CRD) on visceral adipose tissue (VAT) and metabolic profiles in polycystic ovary syndrome (PCOS) have not been extensively investigated. In this study, we investigated whether dulaglutide combined with CRD could further reduce VAT and promote clinical benefits as compared with a CRD regimen alone in overweight or obese PCOS-affected women. Between May 2021 and May 2022, this single-center, randomized, controlled, open-label clinical trial was conducted. Overall, 243 participants with PCOS were screened, of which 68 overweight or obese individuals were randomly randomized to undergo dulaglutide combined with CRD treatment (n = 35) or CRD treatment alone (n = 33). The duration of intervention was set as the time taken to achieve a 7% weight loss goal from baseline body weight, which was restricted to 6 months. The primary endpoint was the difference in the change in VAT area reduction between the groups. The secondary endpoints contained changes in menstrual frequency, metabolic profiles, hormonal parameters, liver fat, and body composition. As compared with the CRD group, the dulaglutide + CRD group had a considerably shorter median time to achieve 7% weight loss. There was no significant between-group difference in area change of VAT reduction (-0.97 cm2, 95% confidence interval from -14.36 to 12.42, p = 0.884). As compared with CRD alone, dulaglutide + CRD had significant advantages in reducing glycated hemoglobin A1c and postprandial plasma glucose levels. The results of the analyses showed different changes in menstruation frequency, additional metabolic profiles, hormonal markers, liver fat, and body composition between the two groups did not differ significantly. Nausea, vomiting, constipation, and loss of appetite were the main adverse events of dulaglutide. These results emphasize the value of dietary intervention as the first line of treatment for PCOS-affected women, while glucagon-like peptide 1 receptor agonist therapy provides an efficient and typically well tolerated adjuvant therapy to aid in reaching weight targets based on dietary therapy in the population of overweight/obese PCOS-affected women.
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The Association of Fried Meat Consumption With the Gut Microbiota and Fecal Metabolites and Its Impact on Glucose Homoeostasis, Intestinal Endotoxin Levels, and Systemic Inflammation: A Randomized Controlled-Feeding Trial.
Gao, J, Guo, X, Wei, W, Li, R, Hu, K, Liu, X, Jiang, W, Liu, S, Wang, W, Sun, H, et al
Diabetes care. 2021;(9):1970-1979
Abstract
OBJECTIVE This randomized controlled-feeding trial aimed to determine the impact of fried meat intake on the gut microbiota and fecal cometabolites and whether such impacts influenced host glucose homoeostasis, intestinal endotoxin levels, and systemic inflammation. RESEARCH DESIGN AND METHODS A total of 117 overweight adults were randomized into two groups. Fifty-nine participants were provided fried meat four times per week, and 58 participants were restricted from fried meat intake, while holding food group and nutrient compositions constant, for 4 weeks. The gut microbiota was analyzed by 16S rRNA sequencing. Glucose and insulin concentrations at 0, 30, 60, and 120 min of an oral glucose tolerance test, fecal microbiota-host cometabolite levels, and intestinal endotoxin and inflammation serum biomarker levels were measured. The area under the curve (AUC) for insulin, insulinogenic index (IGI), and muscle insulin resistance index (MIRI) were calculated. RESULTS The participants who consumed fried meat had lower IGI values than the control subjects, but they had higher MIRI and AUC values of insulin and lipopolysaccharide (LPS), TNF-α, IL-10, and IL-1β levels (P < 0.05). Fried meat intake lowered microbial community richness and decreased Lachnospiraceae and Flavonifractor abundances while increasing Dialister, Dorea, and Veillonella abundances (P FDR <0.05), provoking a significant shift in the fecal cometabolite profile, with lower 3-indolepropionic acid, valeric acid, and butyric acid concentrations and higher carnitine and methylglutaric acid concentrations (P FDR <0.05). Changes in these cometabolite levels were significantly associated with changes in IGI and MIRI values and LPS, FGF21, TNF-α, IL-1β, and IL-10 levels (P < 0.05). CONCLUSIONS Fried meat intake impaired glucose homoeostasis and increased intestinal endotoxin and systemic inflammation levels by influencing the gut microbiota and microbial-host cometabolites.
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The joint effect of energy reduction with calcium supplementation on the risk factors of type 2 diabetes in the overweight population: a two-year randomized controlled trial.
Wei, W, Jiang, W, Gu, W, Wu, H, Jiang, H, Li, G, Song, Q, Huang, J, Wang, X, Wang, L, et al
Aging. 2021;(4):5571-5584
Abstract
Both excessive energy intake and low calcium intake are inversely associated with the aging-related diseases, particularly for type 2 diabetes mellitus(T2DM). This study examined whether energy reduction coupled with calcium supplementation aided in the prevention of T2DM among the overweight population. A randomized controlled trial(RCT) of 1021 overweight participants was performed, in which participants were randomly assigned to 4 groups: 1) energy-reduction group(ERG), 2) calcium supplementation group(CSG), 3) energy-reduction with calcium supplementation group(ER-CSG), 4) control group(CG). Nutritional habits, anthropometric and diabetes-related indicators were measured at baseline and each follow-up time. To analyze the separate effects of dietary energy reduction and calcium supplementation, ERG and ER-CSG were integrated into ERGs. Similarly, CSG and ER-CSG were integrated into CSGs. Compared to the non-energy-reduction groups(NERGs), ERGs had lower values of ΔBMI(-0.9kg/m2), ΔFSG (-0.34mmol/L), ΔHbA1c(0.16%), and ΔHOMA-IR(-0.13), and higher value of ΔGutt index(-5.82). Compared to the non-calcium supplementation groups(NCSGs), the ΔGutt index(-5.46) in CSGs showed a significant decrease. Moreover, these risk factors for T2DM were most effectively ameliorated in ER-CSG group with the decreased values of ΔFSG(-0.42mmol/L), ΔGutt index(-0.73), and the slowest increasing rate value of Δ2h-glucose(0.37mmol/L). This RCT demonstrated that energy-reduction with calcium supplementation was a useful dietary intervention strategy for preventing the development of T2DM in the overweight population.
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Tolvaptan therapy of Chinese cirrhotic patients with ascites after insufficient diuretic routine medication responses: a phase III clinical trial.
Tang, J, Wang, Y, Han, T, Mao, Q, Cheng, J, Ding, H, Shang, J, Zhang, Q, Niu, J, Ji, F, et al
BMC gastroenterology. 2020;(1):391
Abstract
BACKGROUND To determine the safety and efficacy of different doses of tolvaptan for treating Chinese cirrhotic patients with or without hyponatraemia who still had ascites after routine therapy with diuretics. METHODS In the present placebo-controlled, randomized, double-blinded, multicentre clinical trial, patients with cirrhotic ascites who failed to adequately respond to a combination of an aldosterone antagonist plus an orally administered loop diuretic were randomly placed at a 4:2:1 ratio into 3 groups [the 15 mg/day tolvaptan group (N = 301), 7.5 mg/day tolvaptan group (N = 153) and placebo group (N = 76)] for 7 days of treatment. The effects and safety were evaluated on days 4 and 7. A change in body weight from baseline on day 7 of treatment was the primary endpoint. RESULTS The administration of 7.5 or 15 mg/day tolvaptan significantly decreased body weight from baseline on day 7 of treatment compared to that with placebo treatment (P = 0.026; P = 0.001). For the secondary endpoints, changes in abdominal circumference from baseline and improvements in ascites were markedly different in the treatment groups and the placebo group on day 7 (P7.5 = 0.05, P15.0 = 0.002 and P7.5 = 0.037, P15.0 = 0.003), but there was no difference between the 7.5 mg/day and 15 mg/day dosage groups. The 24-h cumulative urine volume was higher in the 7.5 mg/day and 15 mg/day tolvaptan groups than the placebo group (P = 0.002, P < 0.001) and was greater in the 15 mg/day tolvaptan group than the 7.5 mg/day tolvaptan group (P = 0.004). Sodium serum concentrations were higher in patients with hyponatraemia after tolvaptan treatment, with no significant difference between the two dosage groups. The incidence of serious adverse drug reactions was not different between the groups (P = 0.543). CONCLUSIONS Tolvaptan treatment at 7.5 mg per day might be a good therapeutic choice for Chinese cirrhotic patients with ascites who did not achieve satisfactory clinical responses to previous treatment regimens with combination therapy with an aldosterone antagonist and an orally administered loop diuretic. TRIAL REGISTRATION NCT01349348. Retrospectively registered May 2011.
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Tolvaptan treatment improves survival of cirrhotic patients with ascites and hyponatremia.
Wang, S, Zhang, X, Han, T, Xie, W, Li, Y, Ma, H, Liebe, R, Weng, H, Ding, HG
BMC gastroenterology. 2018;(1):137
Abstract
BACKGROUND Although tolvaptan treatment improves hyponatremia, only few studies have investigated whether tolvaptan actually benefits the survival of cirrhotic patients. This study evaluated the impact of tolvaptan on six-month survival of decompensated cirrhotic patients with and without hyponatremia. METHODS Two hundred forty-nine decompensated cirrhotic patients with or without hyponatremia were enrolled in a multicenter cohort study. Patients were divided into two groups according to receiving either tolvaptan or placebo treatment for 7-day. Subsequently, the patients were followed up for 6 months. RESULTS Two hundred thirty patients, including 98 with hyponatremia (tolvaptan vs. placebo: 69 vs. 29) finished the study. Tolvaptan did not alter serum sodium levels and survival outcome of decompensated cirrhotic patients without hyponatremia. However, tolvaptan treatment remarkably improved serum sodium levels and six-month survival in patients with hyponatremia. Following tolvaptan treatment, serum sodium levels were restored to normal in 63.8% of patients, whereas in patients receiving placebo, only 36.2% showed the same effect (P < 0.05). Compared to a six-month survival rate of 68.97% in patients receiving placebo, the survival rate in tolvapatan-treated patients was 89.94% (P < 0.05). Furthermore, six-month survival rate in the tolvaptan-treated hyponatremia patients with resolved serum sodium was 81.32%, whereas the survival in those with unresolved serum sodium was only 24% (P < 0.05). CONCLUSIONS Tolvaptan improves short term survival in most decompensated cirrhotic hyponatremia patients with resolved serum sodium. TRIALS REGISTRATION Clinical trial one: ClinicalTrials.gov ID: NCT00664014 , Registered on April 14, 2008. Clinical trial two: ClinicalTrials.gov ID: NCT01349335 , Registered on March 5, 2010. Clinical trial three: ClinicalTrials.gov ID: NCT01349348 , Registered on May 4, 2011.
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Tolvaptan in Chinese cirrhotic patients with ascites: A randomized, placebo-controlled phase 2 trial.
Wang, YF, Tang, JT, Han, T, Ding, HG, Ye, WJ, Wang, MR, Cheng, J, Yang, YP, Chen, CW, Xie, Q, et al
Journal of digestive diseases. 2018;(3):144-154
Abstract
OBJECTIVE To evaluate tolvaptan as a novel therapeutic option for Chinese patients with liver cirrhosis-associated ascites in a phase 2 clinical trial. METHODS This randomized, double-blind, placebo-controlled, multicenter trial was conducted in patients with insufficient responses to combination therapies of an oral loop diuretic and an aldosterone antagonist. Reduction in body weight and abdominal circumference, increase in 24-h cumulative urine volume and improvement in serum sodium level from baseline to the end of treatment in the tolvaptan groups (15 mg/day or 30 mg/day orally) were compared with those in the placebo group. Drug safety was also assessed. RESULTS Sixty-two patients were allocated to the placebo group, 56 to the tolvaptan 15-mg group and 63 to the tolvaptan 30-mg group. Their mean changes in body weight were -0.5 ± 1.6 kg, -2.1 ± 2.0 kg and -1.9 ± 2.0 kg, respectively. Body weight reductions in both tolvaptan groups were significantly greater than that in the placebo group (difference -1.6, 95% confidence interval [CI] -2.5 to -0.8, and difference -1.4, 95% CI, -2.2 to -0.7, both P < 0.0001). The administration of tolvaptan also significantly reduced the abdominal circumference, increased 24-h cumulative urine volume and serum sodium level compared with placebo. The most common adverse events in the tolvaptan groups were constipation, diarrhea, dry mouth and thirst, with no severe adverse events observed. CONCLUSION Tolvaptan at 15 mg/day significantly reduced the body weight and abdominal circumference in patients with liver cirrhosis-associated ascites, which needs to be confirmed in a phase 3 trial.
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[Effect of aerobic exercise and resistance exercise in improving non-alcoholic fatty liver disease: a randomized controlled trial].
Jia, GY, Han, T, Gao, L, Wang, L, Wang, SC, Yang, L, Zhang, J, Guan, YY, Yan, NN, Yu, HY, et al
Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology. 2018;(1):34-41
Abstract
Objective: To investigate the effect of dietary control combined with different exercise modes on plasma vaspin, irisin, and metabolic parameters in patients with non-alcoholic fatty liver disease (NAFLD) through a randomized open parallel-controlled study. Methods: The patients aged 30-65 years who visited Tianjin Third Central Hospital from January 2013 to December 2014 and were diagnosed with NAFLD by liver ultrasound and fat content determination were screening, and 474 patients were enrolled in this randomized controlled trial and divided into aerobic exercise group, resistance exercise group, and control group. All patients received dietary intervention. The three groups were compared in terms of biochemical parameters, fat content, NFS score, energy metabolic parameters, body composition index, and levels of vaspin and irisin at baseline and after 6 months of intervention. SPSS 19.0 was used for statistical analysis. The t-test, the Mann-Whitney U test, the chi-square test, and an analysis of variance were used for comparison between groups. The multiple imputation method was used for missing data, and the results were included in the intention-to-treat analysis. Results: There were no significant differences in age, sex, anthropometrical parameters, and biochemical parameters between the three groups at baseline. Compared with dietary control alone, aerobic exercise and resistance exercise helped to achieve significant reductions in waist circumference, diastolic pressure, percentage of body fat, volatile fatty acid, fasting blood glucose, homeostasis model assessment of insulin resistance, triglyceride, low-density lipoprotein cholesterol, free fatty acid, uric acid, alanine aminotransferase, and liver fat content after 6 months of intervention (P < 0.05). The aerobic exercise group had a significant increase in non-protein respiratory quotient and significant reductions in body mass index and aspartate aminotransferase after intervention, as well as a significant increase in resting energy expenditure and significant reductions in abdominal fat ratio and total cholesterol after 6 months of resistance exercise (P < 0.05). The aerobic exercise group and the resistance exercise group had a significant reduction in vaspin and a significant increase in irisin after intervention (P < 0.05), and the resistance exercise group had significantly greater changes in these two adipokines than the aerobic exercise group (P < 0.05). Conclusion: Exercise therapy is an effective method for the treatment of metabolism-associated diseases, and a combination of resistance and aerobic exercises is more reasonable and effective in clinical practice. As a relatively safe exercise mode, resistance exercise can also effectively improve the metabolic state of NAFLD patients.
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A randomized clinical trial comparing the efficacy of mandibular implant-supported overdentures and conventional dentures in diabetic patients. Part IV: Comparisons of dietary intake.
Hamada, MO, Garrett, NR, Roumanas, ED, Kapur, KK, Freymiller, E, Han, T, Diener, RM, Chen, T, Levin, S
The Journal of prosthetic dentistry. 2001;(1):53-60
Abstract
STATEMENT OF PROBLEM It is unclear whether the replacement of conventional mandibular dentures with implant-supported overdentures alters the diet and thus improves the nutritional intake of edentulous persons. PURPOSE The purpose of this study was to compare the pretreatment and posttreatment diets of edentulous diabetic patients who received new dentures with either a conventional complete mandibular denture (CD) or a mandibular implant-supported overdenture (IOD). MATERIAL AND METHODS New dentures were made for 89 edentulous diabetic patients with acceptable metabolic control without insulin (NIT) or with insulin (IT). A randomized approach was used to assign 37 patients a mandibular CD and 52 patients a mandibular IOD supported by 2 cylindrical implants. Of the 89 patients, 58 submitted a dietary log for 7 consecutive days before treatment (PT) and 6 months after treatment completion (PTC). An average daily intake of 28 essential nutrients was determined for each patient at each time interval. Separate 2 x 2 x 2 repeated analysis of variance (ANOVA) tests were performed for each nutrient to compare the means of the 2 denture groups (CD and IOD), 2 diabetic groups (NIT and IT), and 2 time intervals (PT and PTC). The intakes were also compared with the recommended daily allowance (RDA). RESULTS ANOVAs for all 28 nutritional variables showed no main effect for either denture type or diabetic treatment. Time effects were seen for magnesium, potassium, copper, and monounsaturated fats. The PTC mean intake of the total sample (N = 58) decreased for all 3 minerals and increased for monounsaturated fats with study dentures. Post hoc tests showed the differences between PT and PTC means to be statistically significant for only magnesium (P=.043) and potassium (P=.015). The percentage of patients with PT intake 25% or more below the RDA ranged from 33% to 85% in the CD group and from 24% to 100% in the IOD group for the same 11 nutrients. PTC fiber intake deficiency was noted in almost all participants. Carbohydrate consumption was markedly lower than that recommended by the American Diabetic Association. CONCLUSION As is often the case with elderly groups, this group of edentulous diabetic patients showed highly comprised nutritional intakes of fiber, vitamins, and minerals. The replacement of old dentures with new dentures that included either a mandibular CD or IOD did not alter patient diets such that the patients improved their nutritional intakes of essential micronutrients and macronutrients.