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Effectiveness of a Food Supplement Based on Glucomannan, D-Chiro-Inositol, Cinnamomum zeylanicum Blume and Inulin in Patients with Metabolic Syndrome.
Citarrella, R, Chianetta, R, Amodeo, S, Mirarchi, L, Licata, A, Soresi, M, Veronese, N, Barbagallo, M, Giannitrapani, L
Nutrients. 2024;(2)
Abstract
Metabolic syndrome (MetS) is associated with cardiovascular risk factors, such as insulin resistance, dyslipidaemia, hypertension and abdominal obesity. Given the growing need to investigate food supplements with positive health effects, this study was aimed at testing the benefits of a specific supplement for people with MetS. Fifty-eight subjects with MetS and T2DM or impaired glucose tolerance assuming metformin, were randomly assigned to take a food supplement of glucomannan, D-chiro-inositol, Cinnamomum zeylanicum blume and inulin at a daily fixed dose of 4 g orally for four months. Body weight, waist circumference, plasma lipid profile (total cholesterol, LDL, HDL and triglyc-erides), plasma glycaemic profile and visceral adiposity index (VAI) were measured at baseline and after four months of supplementation. After 16 weeks, in subjects with T2DM or insulin resistance who took the supplement (+ metformin), there was a significant reduction in body weight and BMI (p < 0.0001), serum insulin (p < 0.05) and the HOMA index (p < 0.01), as well as in the lipaemic pattern, with a significant improvement in total serum cholesterol (p < 0.005), triglycerides (p < 0.03) and LDL (p < 0.02). Our study shows that the food supplement tested is a valid and safe alternative therapeutic approach in the management of MetS and all its resulting risk factors, as its efficacy has been demonstrated across anthropometric, glucose, lipid and hepatic parameters.
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Plant stanol consumption increases anti-COVID-19 antibody responses, independent of changes in serum cholesterol concentrations: a randomized controlled trial.
van Brakel, L, Mensink, RP, Lütjohann, D, Plat, J
The American journal of clinical nutrition. 2024;(4):969-980
Abstract
BACKGROUND People with overweight/obesity generally have impaired immune responses, resulting among others in increased risk of severe complaints and hospitalization after infections with severe acute respiratory syndrome coronavirus 2 (COVID-19), as well as decreased antibody production after vaccinations. Plant stanol ester previously increased the combined IgM/IgG antibody titers toward a hepatitis A vaccination in patients with allergic asthma, but the underlying mechanism is unknown. OBJECTIVES We evaluated whether plant stanol ester consumption improved the immune response in subjects with overweight/obesity after a COVID-19 vaccination. METHODS A double-blind, randomized, placebo-controlled trial was performed. Thirty-two subjects with overweight/obesity consumed products with added plant stanols (4 g/d; provided as plant stanol ester) or control ≥2 wk before receiving their COVID-19 vaccination until 4 wk after vaccination. Antibody titers were analyzed weekly and statistically analyzed using mixed models. Serum metabolic markers and cytokine profiles were also analyzed. RESULTS IgM concentrations against the COVID-19 Spike protein were increased in the plant stanol ester group compared with the control group, with the largest difference observed 2 wk after vaccination [31.2 (0.43, 62.1) BAU/mL, or +139%; Group × Time: P = 0.031]. Subjects that produced very low IgM antibodies produced, as expected, hardly any IgG antibodies. In those with IgG seroconversion, IgG Spike concentrations were also increased in the plant stanol ester group compared with the control group [71.3 (2.51, 140.1) BAU/mL; Group P = 0.043]. Stimulated cytokine concentrations decreased in the plant stanol ester group compared with the control group in all 3 cytokine domains (that is, proinflammatory, T helper [Th1]/Th17, and Th2/regulatory T cells). Between-group differences in serum LDL cholesterol or other metabolic markers were not observed. CONCLUSIONS Consuming plant stanols (4 g/d) affects immune responses to COVID-19 vaccinations, translating into increased serum anti-COVID-19 IgM concentrations in subjects with overweight/obesity. Only in IgG seroconverted subjects, serum anti-COVID-19 IgG concentrations also increase. These effects are independent of reductions in LDL cholesterol. These results suggest that this high-risk group for COVID-19 complications could benefit from plant stanol consumption. This trial was registered at clinicaltrials.gov as NCT04844346.
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Effectiveness of Metaverse Space-Based Exercise Video Distribution in Young Adults: Randomized Controlled Trial.
Mizuta, R, Maeda, N, Tashiro, T, Suzuki, Y, Kuroda, S, Ishida, A, Oda, S, Watanabe, T, Tamura, Y, Komiya, M, et al
JMIR mHealth and uHealth. 2024;:e46397
Abstract
BACKGROUND In response to the serious lack of physical activity among young adults, recent attempts have been made to encourage young people to exercise through exercise video distribution. However, merely distributing videos does not lead to improved physical activity levels. Metaverse space, which enables web-based interaction through avatars, allows users to watch exercise videos in the same space as other avatars. OBJECTIVE This study explored whether exercise video distribution using metaverse space is effective in improving physical activity levels, along with mental health and locomotive function, among young people. METHODS In this parallel-group randomized controlled trial participants were recruited using printed poster displays. A total of 48 young adults aged between 18 and 30 years were assigned to 3 groups of 16 each: the metaverse, YouTube, and control group. To encourage exercise, the metaverse group was given an exercise video each week with a load of around 4-8 metabolic equivalents of tasks (METs) for 8 videos delivered in the metaverse space. The YouTube group was sent a URL on YouTube every week to view exercise videos with the same content as the metaverse group. The control group was given no special instructions. The intervention period was 8 weeks. Pre- and postintervention physical activity, well-being, locomotive syndrome risk tests, and social capital were measured. Although this study was not blinded to the participants, the measurers did not know to which group the participants belonged. Mixed model repeated-measures analyses and a post hoc Wilcoxon signed rank sum test were performed to detect the effects of the intervention in all groups. RESULTS The results of the mixed model repeated-measures analyses showed a significant interaction between groups and before and after the intervention for total physical activity (metaverse group: pre 737.1, SD 609.5 METs/week, post 1575.4, SD 1071.8 METs/week; YouTube group: pre 661.7, SD 710.7 METs/week, post 911.9, SD 1103.3 METs/week; and control group: pre 930.6, SD 665.1 METs/week, post 844.7, SD 701.8 METs/week; P=.04) but none for the indicators of well-being (P=.40), locomotive function scale (P=.17), and social capital (P=.23). A post hoc test showed a significant increase in physical activity in the metaverse group before and after the intervention (P=.006). CONCLUSIONS This study is the first to show that delivering exercise videos through metaverse space can increase physical activity in young adults by providing a gathering space for individuals similarly motivated for exercise practice. This way, the sense of isolation during exercise is reduced compared with merely distributing videos on YouTube. The use of metaverse space in health promotion is likely to spread, and this study provides a useful reference for its exploration. TRIAL REGISTRATION ClinicalTrials.gov NCT06019156; https://ichgcp.net/clinical-trials-registry/NCT06019156.
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Prevalence and predictors of erectile dysfunction among men in the diabetes prevention program outcomes study.
Blair, YA, Doherty, L, Temprosa, M, Pop-Busui, R, Gadde, KM, Singh, P, Owora, AH, Wessells, H, Sarma, AV, ,
Journal of diabetes and its complications. 2024;(2):108669
Abstract
OBJECTIVE To determine burden and identify correlates of erectile dysfunction (ED) among men with prediabetes (PreD) and type 2 diabetes (T2D) enrolled in the Diabetes Prevention Program (DPP) Outcomes Study (DPPOS). RESEARCH DESIGN AND METHODS The 2017 DPPOS visit included administration of the International Index of Erectile Function. Of 648 male participants, 88 % (n = 568) completed the survey. Associations between sociodemographic, behavioral, clinical, and glycemic measures at time of ED assessment, and ED were examined using multivariable logistic regression models in men with PreD and T2D separately. RESULTS Overall, 218 (38 %) men met ED criteria. Prevalence was similar in men with PreD (41 %) and T2D (37 %) (p = 0.4). In all men, age (p < 0.001) increased odds of ED. Among men with PreD, those assigned to intensive lifestyle intervention (ILS), but not metformin, had decreased odds of ED compared with the placebo group (OR = 0.35, 95 % CI = 0.13, 0.94). Non-Hispanic White race was associated with increased odds of ED compared with other races (OR = 4.3; 95 % CI = 1.92, 9.65). Among men with T2D, ED risk did not differ by DPP treatment assignment; however, individuals with metabolic syndrome defined by National Cholesterol Education Program criteria, had increased odds of ED (OR = 1.85, 95 % CI = 1.14, 3.01), as did individuals with depression (OR = 2.05; 95 % CI = 1.10, 3.79). CONCLUSIONS ED is prevalent in men with PreD and T2D. Our finding of reduced odds of ED in men randomized to ILS and with PreD suggests a potential opportunity for risk mitigation in the prediabetes interval. In men who have progressed to T2D, metabolic factors appear to be associated with ED.
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Impact of a Mindfulness Mobile Application on Weight Loss and Eating Behavior in People with Metabolic Syndrome: a Pilot Randomized Controlled Trial.
Matsuhisa, T, Fujie, R, Masukawa, R, Nakamura, N, Mori, N, Ito, K, Yoshikawa, Y, Okazaki, K, Sato, J
International journal of behavioral medicine. 2024;(2):202-214
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Abstract
BACKGROUND Weight-loss approaches involving mindfulness have been reported to reduce overeating behavior. We conducted a preliminary evaluation of the feasibility and effectiveness of a mindfulness mobile application (MMA) combined with a comprehensive lifestyle intervention (CLI) focused on weight loss and eating behaviors for people with metabolic syndrome based on post-intervention follow-up data. METHOD Participants were randomly assigned (1:1) to a CLI group or a CLI + MMA group. Participants received weekly CLI for 13 weeks, followed by telephone counseling for 13 weeks. The CLI + MMA group also had access to the MMA. Feasibility was assessed by the number of people who refused to participate, rate of adherence to the MMA, follow-up rate, and participant satisfaction. The preliminary endpoint was weight change (at 26 weeks). Participants completed the Dutch Eating Behavior Questionnaire (DEBQ). A mixed linear model was used for efficacy analysis. RESULTS Eight of the 40 participants declined to participate. The MMA was used 4.4 ± 1.7 days per week, but the rate of adherence declined over time. The follow-up rate was 100%, and there was no difference in participant satisfaction between the groups. There was no significant group-by-time interaction for weight loss (p = 0.924), but there was a significant interaction for the DEBQ restrained eating score (p = 0.033). CONCLUSIONS This study found that CLI plus MMA was highly feasible and moderately acceptable. There were no significant differences in weight loss between the groups, but the CLI + MMA group showed an increase in restrained eating. Further large-scale studies are needed. TRIAL REGISTRATION Japanese University Hospital Medical Information Network (UMIN-ICDR). Clinical Trial identifier number UMIN000042626.
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Effect of Exercise Training on Some Anti-Inflammatory Adipokines, High Sensitivity C-Reactive Protein, and Clinical Outcomes in Sedentary Adults With Metabolic Syndrome.
Gao, K, Su, Z, Meng, J, Yao, Y, Li, L, Su, Y, Mohammad Rahimi, GR
Biological research for nursing. 2024;(1):125-138
Abstract
OBJECTIVE This study aimed to investigate the effects of aerobic interval training and resistance training on anti-inflammatory adipokines, high sensitivity C-reactive protein, and clinical outcomes in sedentary men with metabolic syndrome. METHODS A total of 33 sedentary men with metabolic syndrome (age: 46.2 ± 4.6 years; body mass index: 35.4 ± 1.9 kg.m2) were randomly assigned to one of 3 groups: aerobic interval training (n = 12), resistance training (n = 10), or control (n = 11). Participants in the exercise groups completed a 12-week training program, 3 sessions per week, while those in the control group maintained their sedentary lifestyle. The levels of high sensitivity C-reactive protein (hs-CRP), omentin-1, adiponectin, lipid profiles, blood pressure, glucose metabolism, body composition, and peak oxygen uptake (VO2peak) were measured at baseline and after the intervention. RESULTS Both aerobic interval training and resistance training significantly improved the levels of omentin-1 and adiponectin, as well as reduced inflammation, as indicated by a decrease in hs-CRP levels. Exercise training also led to significant improvements in lipid profiles, blood pressure, glucose metabolism, and body composition. Specifically, the aerobic interval training group had significantly greater increases in high-density lipoprotein cholesterol and VO2peak, as well as greater reductions in low-density lipoprotein cholesterol, triglycerides, and total cholesterol compared to the resistance training group. CONCLUSION Exercise training, particularly aerobic interval training and resistance training, can be an effective non-pharmacological intervention for managing inflammation and improving cardiovascular health in metabolic syndrome patients.
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Effect of Virgin Coconut Oil (VCO) on Cardiometabolic Parameters in Patients with Dyslipidemia: A Randomized, Add-on Placebo-Controlled Clinical Trial.
Maiti, R, Mohanty, RR, Dey, A, Maji, S, Padhan, M, Mishra, A
Journal of the American Nutrition Association. 2024;(3):244-251
Abstract
OBJECTIVE Statin monotherapy for dyslipidemia is limited by adverse effects and limited effectiveness in certain subgroups like metabolic syndrome. Add-on therapy with an agent with a known safety profile may improve clinical outcomes, and virgin coconut oil (VCO) may be the candidate agent for improving the cardiometabolic profile. The present study was conducted to evaluate the effect of add-on VCO with atorvastatin in dyslipidemia in adults. METHODS A randomized, double-blind clinical trial was conducted on 150 patients with dyslipidemia who were randomized into control and test groups. The control group received atorvastatin monotherapy, whereas the test group received add-on VCO with atorvastatin for 8 weeks. At baseline, demographic, clinical, and biochemical parameters were assessed and repeated after 8 weeks of therapy. The main outcome measures were lipid profile, cardiovascular risk indices, 10-year cardiovascular risk, body fat compositions, and thiobarbituric acid reactive substances (TBARS). RESULTS The increase in HDL in the test group was significantly greater than in the control group (MD: 2.76; 95%CI: 2.43-3.08; p < 0.001). The changes in the atherogenic index (p = 0.003), coronary risk index (p < 0.001), cardiovascular risk index (p = 0.001), and TBARS (p < 0.001) were significantly greater in the test group. The decrease in LDL, total cholesterol and lipoprotein(a), were significantly higher in the control group. There were no significant differences between the groups with respect to the changes in triglyceride, VLDL, and 10-year cardiovascular risk. CONCLUSIONS Add-on VCO (1000 mg/day) with atorvastatin (10 mg/day) can achieve a better clinical outcome in patients with dyslipidemia by increasing HDL and improving oxidative stress cardiovascular risk indices.
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Efficacy of cognitive-behavioural therapy for lifestyle modification in metabolic syndrome: a randomised controlled trial with a 18-months follow-up.
Garcia-Silva, J, Borrego, IRS, Navarrete, NN, Peralta-Ramirez, MI, Águila, FJ, Caballo, VE
Psychology & health. 2024;(2):195-215
Abstract
OBJECTIVE To test the efficacy of cognitive-behavioural therapy (CBT) for lifestyle modification in patients with metabolic syndrome (MetS). DESIGN 76 MetS patients completed this clinical trial, with 18 months follow-up. 45 participants from the experimental group (EG - CBT) and 31 to the control group (CG - usual care). The CBT programme was performed by a psychologist in a face-to-face group format, during 12 weekly sessions lasting 90 minutes. The intervention for the CG consisted of workshops with basic information about MetS and it's associated cardiovascular risk. MAIN OUTCOME MEASURES Efficacy of (CBT) in (MetS) patients. RESULTS Results showed reduction in weight (mean difference - MD -2.633, 95%CI [-4.322, -0.943]; p<.003), waist circumference (MD -2.944, 95%CI [-5.090, -0.798]; p<.008), body mass index (MD -0.915, 95%CI [-1.494, -0.335]; p<.003), systolic (MD -0.046, 95%CI [-0.685, -0.023]; p<.0002) diastolic blood pressure (MD -4.777, 95%CI [-7.750, -1.804]; p<.002), and cardiovascular risk score after 18 months. An increase in adherence to the Mediterranean diet and assertiveness and a reduction in anger were observed in EG. The CG did not show any significant differences. CONCLUSION The CBT focused on changes in lifestyle seems to be effective in the reduction of MetS and cardiovascular risk factors. TRIAL REGISTRATION Registered at clinicaltrials.gov (NCT02949622) - PROMETS (Multimodal Intervention Program for Patients with Metabolic Syndrome).
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Effect of an intensive lifestyle intervention on the structural and functional substrate for atrial fibrillation in people with metabolic syndrome.
Rossello, X, Ramallal, R, Romaguera, D, Alonso-Gómez, ÁM, Alonso, A, Tojal-Sierra, L, Fernández-Palomeque, C, Martínez-González, MÁ, Garrido-Uriarte, M, López, L, et al
European journal of preventive cardiology. 2024;(5):629-639
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AIMS: To evaluate the effect of an intensive lifestyle intervention (ILI) on the structural and functional cardiac substrate of atrial fibrillation (AF) in overweight or obese people with metabolic syndrome (Mets). METHODS AND RESULTS Participants of the PREvención con DIeta MEDiterranea-Plus trial (n = 6874) were randomized 1:1 to an ILI programme based on an energy-reduced Mediterranean diet, increased physical activity, and cognitive-behavioural weight management or to a control intervention of low-intensity dietary advice. A core echocardiography lab evaluated left atrial (LA) strain, function, and volumes in 534 participants at baseline, 3-year, and 5-year follow-ups. Mixed models were used to evaluate the effect of the ILI on LA structure and function. In the subsample, the baseline mean age was 65 years [standard deviation (SD) 5 years], and 40% of the participants were women. The mean weight change after 5 years was -3.9 kg (SD 5.3 kg) in the ILI group and -0.3 kg (SD 5.1 kg) in the control group. Over the 5-year period, both groups experienced a worsening of LA structure and function, with increases in LA volumes and stiffness index and decreases in LA longitudinal strain, LA function index, and LA emptying fraction over time. Changes in the ILI and control groups were not significantly different for any of the primary outcomes {LA emptying fraction: -0.95% [95% confidence interval (CI) -0.93, -0.98] in the control group, -0.97% [95% CI -0.94, -1.00] in the ILI group, Pbetween groups = 0.80; LA longitudinal strain: 0.82% [95% CI 0.79, 0.85] in the control group, 0.85% [95% CI 0.82, 0.89] in the ILI group, Pbetween groups = 0.24} or any of the secondary outcomes. CONCLUSION In overweight or obese people with Mets, an ILI had no impact on the underlying structural and functional LA substrate measurements associated with AF risk.
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Effect of Teneligliptin 20 mg Twice Daily on Glucagon-Like Peptide-1 Levels and Its Influence on Non-Glycemic Components in Non-Diabetic Obese Individuals.
Pelluri, R, Kongara, S, Nagasubramanian, VR, Mahadevan, S, Chimakurthy, J
Metabolic syndrome and related disorders. 2024;(2):90-96
Abstract
Background and Aims: Teneligliptin is an oral antidiabetic agent, it can persevere glucagon-like peptide-1 (GLP-1) by inhibiting dipeptidyl peptidase enzyme. In addition, it has rare incidence of hypoglycemia. Hence, this study aimed to test the effect of teneligliptin 20 mg twice daily along with low carbohydrate diet and physical exercise on change of body weight and insulin resistance in nondiabetic obese subjects. Materials and Methods: It is a prospective, randomized, double-blind, placebo-controlled, parallel group study carried out at outpatient department of an endocrinology hospital over the period of 48 weeks. Teneligliptin 20 mg twice daily 30 min before food (low carbohydrate diet [LCD]) with regular physical exercise, and control group was kept with placebo twice daily 30 min before food LCD with regular physical exercise. This study was registered in clinical trial registry of India [CTRI/2020/02/023329]. Results: A total of 150 nondiabetic obese subjects were randomized into test (n = 75) and control groups (n = 75). At the end of 48 weeks there was significant improvement in GLP-1, simplified nutrition assessment questionnaire (SNAQ) score, homeostasis model assessment of insulin resistance (HOMA-IR), triglycerides (TG), and body weight. The mean difference and 95% confidence interval of GLP-1 (pg/mL) was 76.42 (44.42-148.41) (P = 0.37); SNAQ score, -1.64 (-2.48 to -0.81) (P = 0.000); HOMA-IR, -0.9 (-0.59 to -0.38) (P = 0.000); TG (mg/dL) -29.37 (-44.46 to -14.07) (P = 0.000); reduction of body weight (kilograms) -3.09 (-6.11 to -0.07) (P = 0.043). Conclusion: Findings of this study reveals that teneligliptin-treated group showed significant improvement in GLP-1 levels, reduced insulin resistance, body weight, TG, appetite, and metabolic syndrome. Teneligliptin is well tolerated, except in upper respiratory tract infections. CTR number: CTRI/2020/02/023329.