-
1.
Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial.
Aronne, LJ, Sattar, N, Horn, DB, Bays, HE, Wharton, S, Lin, WY, Ahmad, NN, Zhang, S, Liao, R, Bunck, MC, et al
JAMA. 2024;(1):38-48
Abstract
IMPORTANCE The effect of continued treatment with tirzepatide on maintaining initial weight reduction is unknown. OBJECTIVE To assess the effect of tirzepatide, with diet and physical activity, on the maintenance of weight reduction. DESIGN, SETTING, AND PARTICIPANTS This phase 3, randomized withdrawal clinical trial conducted at 70 sites in 4 countries with a 36-week, open-label tirzepatide lead-in period followed by a 52-week, double-blind, placebo-controlled period included adults with a body mass index greater than or equal to 30 or greater than or equal to 27 and a weight-related complication, excluding diabetes. INTERVENTIONS Participants (n = 783) enrolled in an open-label lead-in period received once-weekly subcutaneous maximum tolerated dose (10 or 15 mg) of tirzepatide for 36 weeks. At week 36, a total of 670 participants were randomized (1:1) to continue receiving tirzepatide (n = 335) or switch to placebo (n = 335) for 52 weeks. MAIN OUTCOMES AND MEASURES The primary end point was the mean percent change in weight from week 36 (randomization) to week 88. Key secondary end points included the proportion of participants at week 88 who maintained at least 80% of the weight loss during the lead-in period. RESULTS Participants (n = 670; mean age, 48 years; 473 [71%] women; mean weight, 107.3 kg) who completed the 36-week lead-in period experienced a mean weight reduction of 20.9%. The mean percent weight change from week 36 to week 88 was -5.5% with tirzepatide vs 14.0% with placebo (difference, -19.4% [95% CI, -21.2% to -17.7%]; P < .001). Overall, 300 participants (89.5%) receiving tirzepatide at 88 weeks maintained at least 80% of the weight loss during the lead-in period compared with 16.6% receiving placebo (P < .001). The overall mean weight reduction from week 0 to 88 was 25.3% for tirzepatide and 9.9% for placebo. The most common adverse events were mostly mild to moderate gastrointestinal events, which occurred more commonly with tirzepatide vs placebo. CONCLUSIONS AND RELEVANCE In participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04660643.
-
2.
Effects of oral oligopeptide preparation and exercise intervention in older people with sarcopenia: a randomized controlled trial.
Liao, X, Cheng, D, Li, J, Zhu, L, Zhang, S, Jing, X, Shi, L
BMC geriatrics. 2024;(1):260
Abstract
BACKGROUND Nutrition and exercise are important interventions for sarcopenia. There were few studies on oral oligopeptide nutrition preparations combined with exercise to intervene in the older people with sarcopenia. The aim of this study was to verify the effectiveness of oligopeptide nutrition preparation combined with exercise intervention on the older people with sarcopenia in community. METHODS A total of 219 subjects aged 65 years or older with sarcopenia were randomly divided into 4 groups. The nutrition group (n = 58) was given individualized nutrition education and oral oligopeptide nutrition preparation. The exercise group (n = 50) received exercise intervention. The combined group (n = 52) received both oral nutrition preparation and exercise interventions. The control group (n = 59) only received individualized nutrition education. The nutrition preparation can provide energy 185kcal and protein 24.2g per day. The exercise intervention including warm-up exercise, resistance exercise and aerobic exercise, the training time was 60min for 5 times every week. The intervention lasted for 16 weeks. Hand grip strength, gait speed, body composition and hematology parameters were measured before and after intervention. RESULTS A total of 159 subjects completed the study. Compared with baseline, the left grip strength and 6-m walking speed of the subjects in nutrition group increased significantly after the intervention, and the grip strength of both hands in exercise group and combined group increased significantly. The body weight of the subjects in nutrition group, exercise group and combined group increased significantly after intervention, but no increase in soft lean mass (SLM) and skeletal muscle mass (SMM) was observed in any of the four groups. The fat-free mass (FFM) of the legs of the control group, exercise group and nutrition group decreased after intervention, and only the FFM of the legs of the combined group maintained the level before the intervention. CONCLUSION Both oral peptide nutrition and exercise interventions can improve the muscle strength or function of the older people with sarcopenia. However, there were no increases in muscle mass observed. TRIAL REGISTRATION ChiCTR, ChiCTR2100052135. Registered 20 October 2021, https://www.chictr.org.cn/showproj.html?proj=135743.
-
3.
Effects of the Chinese heart-healthy diet (Sichuan cuisine) on lowering blood pressure in adults with hypertension: a randomized controlled feeding trial.
Chen, H, Su, D, Guo, Y, Chen, C, Chen, S, Zhang, S, Ding, Y, Li, M, Tong, G, Zeng, G
Asia Pacific journal of clinical nutrition. 2024;(1):11-22
Abstract
BACKGROUND AND OBJECTIVES Sichuan cuisine is characterized by high salt and oil content. We aimed to evaluate the effects of the Sichuan cuisine version of Chinese heart-healthy diet (CHH diet-SC) on blood pressure reduction among hypertensive adults. METHODS AND STUDY DESIGN The Chinese heart-healthy diet (CHH) trial was a multicenter randomized controlled feeding trial among Chinese hypertensive people. We conducted a secondary analysis of the CHH trial using data from the Sichuan center in Southwest China. Fifty-three people aged 25 to 75 years with a mean systolic blood pressure (SBP) between 130 and 159 mmHg were enrolled. Eligible participants underwent a 1-week run-in period with the typical local diet and were randomized 1:1 to consume the CHH diet-SC (n=27) or typical local diet (n=26) for the next 4-week. The primary outcome was the net change in SBP, the secondary outcomes included diastolic blood pressure (DBP), mean arterial pressure (MAP), and the rate of BP control. RESULTS Compared with the control group, the CHH diet-SC decreased cooking salt, oil, and red meat content and increased inclusion of whole grains, fruits, seafood, low-fat dairy, soybean, and nuts; the SBP experienced reductions of 7.54, 8.60, 9.14, and 10.1 mmHg at the end of weeks 1 through 4; the DBP was reduced 4.01 mmHg at week 4; the MAP was significantly reduced 6.02 mmHg finally; and rate of BP control significantly increased (p<0.05). CONCLUSIONS Adoption of the CHH diet-SC for 4 weeks can significantly reduce BP and increase the rate of BP control in hypertensive adults.
-
4.
The efficacy and safety of sertraline in maintenance hemodialysis patients with depression: A randomized controlled study.
Zhang, S, Xu, Y, Xia, Y
Journal of affective disorders. 2024;:60-66
Abstract
OBJECTIVE To determine the efficacy and safety of sertraline in maintenance hemodialysis (MHD) patients with depression. METHODS A randomized controlled trial was conducted involving 125 MHD patients with depression. The treatment group received sertraline, while the control group did not receive any antidepressant treatment. After 12 weeks, we compared the changes in the Hamilton Depression Rating Scale (HAMD), the Medication Adherence Report Scale-5 (MARS-5), the Mini Nutritional Assessment short-form (MNA-SF), the Kidney Disease Quality of Life-36 (KDQOL-36) scores, selected clinical and laboratory indicators, and the incidence of drug-related adverse reactions between the two groups. RESULTS After 12 weeks of treatment, the HAMD scores of patients in the treatment group significantly decreased compared to before treatment and were lower than those in the control group. The KDQOL-36, MARS-5, and MNA-SF scores in the treatment group also significantly improved compared to before treatment and were superior to those in the control group. Albumin and hemoglobin levels in the treatment group significantly increased, while C-reactive protein significantly decreased. The incidence of nausea was slightly higher in the treatment group, and was mostly relieved after reducing the dosage of sertraline. LIMITATIONS This study is a single-center, small-sample study with a relatively short duration of treatment and follow-up. CONCLUSIONS Sertraline can alleviate depressive symptoms, and improve the quality of life and treatment compliance of MHD patients, while improving chronic inflammation, malnutrition, and anemia. However, starting with a low dose and reducing the maintenance dose is recommended when administering sertraline.
-
5.
Does an antihypertensive diet cost more? Analysis from the Chinese Heart-Healthy diet trial.
Guo, Y, Su, D, Chen, H, Ding, Y, Zhang, S, Sun, H, Chen, D, Yin, W, Li, X, Zeng, G
Public health nutrition. 2024;(1):e73
-
-
Free full text
-
Abstract
OBJECTIVE To determine whether the Chinese heart-healthy diet (Sichuan cuisine version) (CHH diet-SC) was more expensive than the conventional Sichuan diet and explore the food groups and nutrients that mainly affected the cost of CHH diet-SC. DESIGN Cost analysis of 4-week intervention diets in the Sichuan center representing southwestern China in the CHH diet study. SETTING A multicentre, parallel-group, single-blind, randomised feeding trial evaluating the efficacy of lowering blood pressure with the cuisine-based CHH diet. PARTICIPANTS Totally, fifty-three participants with hypertension aged 25-75 years in the Sichuan center were randomised into the control group (n 26) or the CHH diet-SC group (n 27). RESULTS The CHH diet-SC was more expensive than the control diet (¥27·87 ± 2·41 v. ¥25·18 ± 2·79 equals $3·90 ± 0·34 v. $3·52 ± 0·39, P < 0·001), and the incremental cost-effectiveness ratio for a 1-mm Hg systolic blood pressure reduction was ¥9·12 ($1·28). Intakes and the cost of seafood, dairy products, fruits, soybeans and nuts, whole grains and mixed beans were higher for the CHH diet-SC than for the control diet (P < 0·001). Intakes of vitamin B1, vitamin B6, vitamin C, Mg and phosphorus were positively correlated with the cost (P < 0·05). CONCLUSIONS The CHH diet-SC costs more than the conventional Sichuan diet, partly due to the high cost of specific food groups. Positive correlations between the intakes of vitamin B1, vitamin B6, vitamin C, Mg, phosphorus and the dietary cost could be a direction to adjust the composition within the food groups to reduce the cost of the CHH diet-SC.
-
6.
Icosapent ethyl therapy for very high triglyceride levels: a 12-week, multi-center, placebo-controlled, randomized, double-blinded, phase III clinical trial in China.
Wang, Z, Zhang, X, Qu, Y, Zhang, S, Chen, Y, Chen, X, Qi, X, Liu, P, Liu, S, Jiang, S, et al
Lipids in health and disease. 2023;(1):71
Abstract
OBJECTIVES Eicosapentaenoic acid in its ethyl ester form is the single active component of icosapent ethyl (IPE). This study was a phase III, multi-center trial assessing the safety and efficiency of IPE for treating very high triglyceride (TG) in a Chinese cohort. METHODS Patients having TG levels (5.6-22.6 mmol/L) were enrolled and randomly assigned to receive a treatment of oral intake of 4 g or 2 g/day of IPE, or placebo. Before and after 12 weeks of treatment, TG levels were assessed and the median was calculated to determine the change between the baseline and week 12. In addition to examining TG levels, the impact of such treatments on other lipid changes was also investigated. The official Drug Clinical Trial Information Management Platform has registered this study (CTR20170362). RESULTS Random assignments were performed on 373 patients (mean age 48.9 years; 75.1% male). IPE (4 g/day) lowered TG levels by an average of 28.4% from baseline and by an average of 19.9% after correction for placebo (95% CI: 29.8%-10.0%, P < 0.001). In addition, plasma concentration of non-high-density lipoprotein cholesterol (non-HDL-C), very low-density lipoprotein (VLDL) cholesterol, and VLDL-TG remarkedly reduced after IPE (4 g/day) treatment by a median of 14.6%, 27.9%, and 25.2%, respectively compared with participants in placebo group. Compared to the placebo, neither 4 nor 2 g of IPE daily elevated LDL-C levels with statistical significance. IPE was well tolerated by all the treatment groups. CONCLUSIONS IPE at 4 g/day dramatically lowered other atherogenic lipids without a noticeable increase in LDL-C, thereby decreasing TG levels in an exceptionally high-TG Chinese population.
-
7.
Establishment and validation of a nomogram model for postoperative surgical site infection after transforaminal lumbar interbody fusion: A retrospective observational study.
Liu, H, Zhang, W, Zhang, Y, Zhang, S, Jin, G, Li, X
Surgery. 2023;(5):1220-1226
Abstract
BACKGROUND Surgical site infection is one of the serious complications of transforaminal lumbar interbody fusion surgery, and many factors affect its occurrence. METHODS A total of 1,277 patients who underwent transforaminal lumbar interbody fusion between 2018 and 2021 were enrolled in this study. Subsequently, 1,277 patients were randomly assigned to a training cohort (N = 958) and a validation cohort (N = 319) in a 3:1 ratio. We developed a nomogram according to the results of binary logistic regression analysis in the training cohort. The nomogram's predictive accuracy and discriminative ability were evaluated by calibration curve and receiver operating characteristic analysis. Decision curve analysis was performed to estimate the clinical value of our nomogram. RESULTS In univariate and multivariate analysis, smoking, diabetes, intraoperative blood loss, American Society of Anesthesiologists class ≥III, serum calcium, albumin, and serum glucose were identified as significant independent predictors. The nomogram was developed using these independent predictors, which showed good diagnostic accuracy for surgical site infection of the training and validation cohorts. The calibration curves for the 2 cohorts showed optimal agreement between nomogram prediction and actual observation. The decision curve analysis of the nomogram model showed the great clinical use of the nomogram. CONCLUSION The nomogram based on smoking, diabetes, intraoperative blood loss, American Society of Anesthesiologists class, serum calcium, albumin, and serum glucose has the potential as a clinically useful predictive tool of surgical site infection after transforaminal lumbar interbody fusion surgery. It is helpful to visualize the risk factors of surgical site infection.
-
8.
Psychobiotic Lactobacillus plantarum JYLP-326 relieves anxiety, depression, and insomnia symptoms in test anxious college via modulating the gut microbiota and its metabolism.
Zhu, R, Fang, Y, Li, H, Liu, Y, Wei, J, Zhang, S, Wang, L, Fan, R, Wang, L, Li, S, et al
Frontiers in immunology. 2023;14:1158137
-
-
-
Free full text
Plain language summary
Test anxiety, characterised by feelings of failure, tension, and worrying when an individual faces a vital test for promoting, occurs prevalently among college students. Lactobacillus plantarum, has become increasingly popular in reducing the severity of anxiety and depression in stressed animal models. The main aim of this study was to evaluate the psychological effects of Lactobacillus plantarum JYLP-326 (JYLP-326) on exam stress-induced behaviours like anxiety, depression, and insomnia. This study enrolled 60 anxious and 30 un-anxious undergraduates preparing for the approaching exams. Out of the 60 anxious participants, 30 were selected randomly to receive the probiotic product and the other 30 received a placebo product. The 30 un-anxious students were assigned as the healthy control group. Results demonstrated that the intervention of JYLP-326 is effective in alleviating exam stress-induced symptoms in college students. Furthermore, it also protected against exam stress-induced dysbiosis of the gut microbiota and the disturbances of faecal metabolomic. Authors conclude that the changed gut microbiota genera and faecal metabolites were closely associated with stress-related symptoms like anxiety/depression and insomnia, indicating that they might be regarded as biomarkers for diagnosing and treating stress and anxiety disorders.
Abstract
INTRODUCTION Test anxiety is a common issue among college students, which can affect their physical and psychological health. However, effective interventions or therapeutic strategies are still lacking. This study aims to evaluate the potential effects of Lactobacillus plantarum JYLP-326 on test anxious college students. METHODS Sixty anxious students were enrolled and randomly allocated to the placebo group and the probiotic group. Both groups were instructed to take placebo and JYLP-326 products twice per day for three weeks, respectively. Thirty unanxious students with no treatments were assigned to a regular control group. The anxiety, depression, and insomnia questionnaires were used to measure students' mental states at the baseline and the end of this study. 16S rRNA sequencing and untargeted metabolomics were performed to analyze the changes in the gut microbiota and fecal metabolism. RESULTS The questionnaire results suggested that JYLP-326 administration could relieve the symptoms of anxiety, depression, and insomnia in test anxious students. The gut microbiomes of the placebo group showed a significantly greater diversity index than the control group (p < 0.05). An increased abundance of Bacteroides and Roseburia at the genus level was observed in the placebo group, and the relative abundance of Prevotella and Bifidobacterium decreased. Whereas, JYLP-326 administration could partly restore the disturbed gut microbiota. Additionally, test anxiety was correlated with disordered fecal metabolomics such as a higher Ethyl sulfate and a lower Cyclohexylamine, which could be reversed after taking JYLP-326. Furthermore, the changed microbiota and fecal metabolites were significantly associated with anxiety-related symptoms. CONCLUSION The results indicate that the intervention of L. plantarum JYLP-326 could be an effective strategy to alleviate anxiety, depression, and insomnia in test anxious college students. The potential mechanism underlying this effect could be related to the regulation of gut microbiota and fecal metabolites.
-
9.
Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons.
Barnes, LL, Dhana, K, Liu, X, Carey, VJ, Ventrelle, J, Johnson, K, Hollings, CS, Bishop, L, Laranjo, N, Stubbs, BJ, et al
The New England journal of medicine. 2023;389(7):602-611
-
-
-
Free full text
-
Plain language summary
Lifestyle interventions targeting diet are a possible approach that could affect public health. Most clinical trials have investigated comprehensive diets, in contrast to dietary manipulation of single foods or nutrients. The aim of this study was to evaluate the effects of a 3-year dietary intervention on cognitive decline and brain-imaging markers of dementia and Alzheimer’s disease in older, cognitively unimpaired adults at risk for dementia because of family history. This study was a 3-year, two-site, randomised, controlled trial. The participants were randomly assigned to follow the MIND diet with mild caloric restriction for weight loss or their usual diet with the same mild caloric restriction for weight loss (control diet). Participants were randomly assigned in a 1:1 ratio. Results showed that the participants who followed the MIND diet had small improvements in a global measure of cognition that were similar to those who followed a control diet with mild caloric restriction. Authors concluded that brain health, cognitive function and brain imaging outcomes (after 3 years) did not differ significantly between participants who followed the MIND diet and those who followed a control diet with a mild caloric restriction.
Abstract
BACKGROUND Findings from observational studies suggest that dietary patterns may offer protective benefits against cognitive decline, but data from clinical trials are limited. The Mediterranean-DASH Intervention for Neurodegenerative Delay, known as the MIND diet, is a hybrid of the Mediterranean diet and the DASH (Dietary Approaches to Stop Hypertension) diet, with modifications to include foods that have been putatively associated with a decreased risk of dementia. METHODS We performed a two-site, randomized, controlled trial involving older adults without cognitive impairment but with a family history of dementia, a body-mass index (the weight in kilograms divided by the square of the height in meters) greater than 25, and a suboptimal diet, as determined by means of a 14-item questionnaire, to test the cognitive effects of the MIND diet with mild caloric restriction as compared with a control diet with mild caloric restriction. We assigned the participants in a 1:1 ratio to follow the intervention or the control diet for 3 years. All the participants received counseling regarding adherence to their assigned diet plus support to promote weight loss. The primary end point was the change from baseline in a global cognition score and four cognitive domain scores, all of which were derived from a 12-test battery. The raw scores from each test were converted to z scores, which were averaged across all tests to create the global cognition score and across component tests to create the four domain scores; higher scores indicate better cognitive performance. The secondary outcome was the change from baseline in magnetic resonance imaging (MRI)-derived measures of brain characteristics in a nonrandom sample of participants. RESULTS A total of 1929 persons underwent screening, and 604 were enrolled; 301 were assigned to the MIND-diet group and 303 to the control-diet group. The trial was completed by 93.4% of the participants. From baseline to year 3, improvements in global cognition scores were observed in both groups, with increases of 0.205 standardized units in the MIND-diet group and 0.170 standardized units in the control-diet group (mean difference, 0.035 standardized units; 95% confidence interval, -0.022 to 0.092; P = 0.23). Changes in white-matter hyperintensities, hippocampal volumes, and total gray- and white-matter volumes on MRI were similar in the two groups. CONCLUSIONS Among cognitively unimpaired participants with a family history of dementia, changes in cognition and brain MRI outcomes from baseline to year 3 did not differ significantly between those who followed the MIND diet and those who followed the control diet with mild caloric restriction. (Funded by the National Institute on Aging; ClinicalTrials.gov number, NCT02817074.).
-
10.
Efficacy of Mobile-Based Cognitive Behavioral Therapy on Lowering Low-density Lipoprotein Cholesterol Levels in Patients With Atherosclerotic Cardiovascular Disease: Multicenter, Prospective Randomized Controlled Trial.
Li, D, Xu, T, Xie, D, Wang, M, Sun, S, Wang, M, Zhang, S, Yang, X, Zhang, Z, Wang, S, et al
Journal of medical Internet research. 2023;:e44939
Abstract
BACKGROUND Elevated low-density lipoprotein cholesterol (LDL-C) is an established risk factor for atherosclerotic cardiovascular disease (ASCVD). However, low adherence to medication and lifestyle management has limited the benefits of lowering lipid levels. Cognitive behavioral therapy (CBT) has been proposed as a promising solution. OBJECTIVE This trial aimed to evaluate the efficacy of mobile-based CBT interventions in lowering LDL-C levels in patients with ASCVD. METHODS This multicenter, prospective, randomized controlled trial enrolled 300 patients with ASCVD, who were randomly assigned to the mobile-based CBT intervention group and the control group in a ratio of 1:1. The intervention group received CBT for ASCVD lifestyle interventions delivered by WeChat MiniApp: "CBT ASCVD." The control group only received routine health education during each follow-up. The linear regression and logistic regression analyses were used to determine the effects of a mobile-based CBT intervention on LDL-C, triglyceride, C-reactive protein, the score of General Self-Efficacy Scale (GSE), quality of life index (QL-index), and LDL-C up-to-standard rate (<1.8 mmol/L) at the first, third, and sixth months. RESULTS Finally, 296 participants completed the 6-month follow-up (CBT group: n=148; control group: n=148). At baseline, the mean LDL-C level was 2.48 (SD 0.90) mmol/L, and the LDL-C up-to-standard rate (<1.8 mmol/L) was 21.3%. Mobile-based CBT intervention significantly increased the reduction of LDL-C change (%) at the 6-month follow-up (β=-10.026, 95% CI -18.111 to -1.940). In addition, this benefit remained when baseline LDL-C <1.8 mmol/L (β=-24.103, 95% CI -43.110 to -5.095). Logistic regression analysis showed that mobile-based CBT intervention moderately increased the LDL-C up-to-standard rates (<1.8 mmol/L) in the sixth month (odds ratio 1.579, 95% CI 0.994-2.508). For GSE and QL-index, mobile-based CBT intervention significantly increased the change of scores (%) at the 1-, 3-, and 6-month follow-up (all P values <.05). CONCLUSIONS In patients with ASCVD, mobile-based CBT is effective in reducing LDL-C levels (even for those who already had a standard LDL-C) and can improve self-efficacy and quality of life. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR2100046775; https://www.chictr.org.cn/showproj.aspx?proj=127140.