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Traditional Atlantic Diet and Its Effect on Health and the Environment: A Secondary Analysis of the GALIAT Cluster Randomized Clinical Trial.
Cambeses-Franco, C, Gude, F, Benítez-Estévez, AJ, González-García, S, Leis, R, Sánchez-Castro, J, Moreira, MT, Feijoo, G, Calvo-Malvar, M
JAMA network open. 2024;(2):e2354473
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Abstract
IMPORTANCE The universal call to action for healthier and more sustainable dietary choices is the framework of the United Nations's Sustainable Development Goals. The Atlantic diet, originating from the northwest of the Iberian Peninsula, represents an example of a traditional diet that aligns with these principles. OBJECTIVE To explore a 6-month intervention based on the Atlantic diet's effects on metabolic and environmental health, assessing metabolic syndrome (MetS) incidence and the carbon footprint. DESIGN, SETTING, AND PARTICIPANTS The Galician Atlantic Diet study was a 6-month randomized clinical trial designed to assess the effects of this regional traditional diet on families' eating habits. The study was conducted from March 3, 2014, to May 29, 2015, at a local primary health care center in the rural town of A Estrada in northwestern Spain and involved a multisectoral collaboration. Families were randomly selected from National Health System records and randomized 1:1 to an intervention or control group. This secondary analysis of the trial findings was performed between March 24, 2021, and November 7, 2023. INTERVENTIONS Over 6 months, families in the intervention group received educational sessions, cooking classes, written supporting material, and foods characteristic of the Atlantic diet, whereas those randomized to the control group continued with their habitual lifestyle. MAIN OUTCOMES AND MEASURES The main outcomes were MetS incidence, defined per National Cholesterol Education Program Adult Treatment Panel III guidelines, and carbon footprint emissions as an environmental metric using life cycle assessment with daily dietary intake as the functional unit. RESULTS Initially, 250 families were randomized (574 participants; mean [SD] age, 46.8 [15.7] years; 231 males [40.2%] and 343 females [59.8%]). The intervention group included 126 families (287 participants) and the control group, 124 families (287 participants). Ultimately, 231 families completed the trial. The intervention significantly reduced the risk of incident cases of MetS (rate ratio, 0.32; 95% CI, 0.13-0.79) and had fewer MetS components (proportional odds ratio, 0.58; 95% CI, 0.42-0.82) compared with the control condition. The intervention group did not have a significantly reduced environmental impact in terms of carbon footprint emissions compared with the control group (-0.17 [95% CI, -0.46 to 0.12] kg CO2 equivalents/person/d). CONCLUSIONS AND RELEVANCE These findings provide important evidence that a family-focused dietary intervention based on a traditional diet can reduce the risk of incident MetS. Further research is needed to understand the underlying mechanisms and determine the generalizability to other populations, taking into account regional cultural and dietary variations. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02391701.
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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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Collinsella aerofaciens as a predictive marker of response to probiotic treatment in non-constipated irritable bowel syndrome.
Gargari, G, Mantegazza, G, Cremon, C, Taverniti, V, Valenza, A, Barbaro, MR, Marasco, G, Duncan, R, Fiore, W, Ferrari, R, et al
Gut microbes. 2024;16(1):2298246
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Irritable bowel syndrome (IBS) is a common disorder of gut-brain interaction in which recurrent abdominal pain is associated with defecation or a change in bowel habits. Various therapeutic options for IBS target the underlying pathophysiological aspects of the condition. Unfortunately, no single approach can effectively address this disorder’s diverse manifestations simultaneously. The aim of this study was to identify markers for recognising non-constipated (NC) IBS patients that may show significant clinical improvements upon treatment with the probiotic strain Lacticaseibacillus paracasei DG (LDG). This study is based on a multicentre, randomised, double-blind, parallel-group, placebo-controlled clinical trial. A total of 63 patients were included in this study who were randomised to receive a probiotic treatment or placebo capsules for 12 weeks. Results showed that the probiotic bacterium LDG can be clinically effective in a subgroup of non-constipated IBS patients characterised by an altered faecal microbiota which resembles that observed in metabolic syndrome-associated pathologic or pre-pathologic conditions. Furthermore, a bacterium reported to contribute to pro-inflammatory immune states, was positively associated with markers of increased endothelial permeability and liver functionality Authors concluded that an analysis of the faecal microbiota focused on particular bacteria could permit the identification of NC-IBS patients who can obtain a significant clinical benefit from the probiotic treatment.
Abstract
Probiotics are exploited for adjuvant treatment in IBS, but reliable guidance for selecting the appropriate probiotic to adopt for different forms of IBS is lacking. We aimed to identify markers for recognizing non-constipated (NC) IBS patients that may show significant clinical improvements upon treatment with the probiotic strain Lacticaseibacillus paracasei DG (LDG). To this purpose, we performed a post-hoc analysis of samples collected during a multicenter, double-blind, parallel-group, placebo-controlled trial in which NC-IBS patients were randomized to receive at least 24 billion CFU LDG or placebo capsules b.i.d. for 12 weeks. The primary clinical endpoint was the composite response based on improved abdominal pain and fecal type. The fecal microbiome and serum markers of intestinal (PV1 and zonulin), liver, and kidney functions were investigated. We found that responders (R) in the probiotic arm (25%) differed from non-responders (NR) based on the abundance of 18 bacterial taxa, including the families Coriobacteriaceae, Dorea spp. and Collinsella aerofaciens, which were overrepresented in R patients. These taxa also distinguished R (but not NR) patients from healthy controls. Probiotic intervention significantly reduced the abundance of these bacteria in R, but not in NR. Analogous results emerged for C. aerofaciens from the analysis of data from a previous trial on IBS with the same probiotic. Finally, C. aerofaciens was positively correlated with the plasmalemmal vesicle associated protein-1 (PV-1) and the markers of liver function. In conclusion, LDG is effective on NC-IBS patients with NC-IBS with a greater abundance of potential pathobionts. Among these, C. aerofaciens has emerged as a potential predictor of probiotic efficacy.
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Enhancing Lifestyles in the Metabolic syndrome (ELM) multisite behavioral efficacy trial. Design and baseline cohort.
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American heart journal. 2024;:136-155
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Abstract
BACKGROUND Prevalence of metabolic syndrome (MetS) increased from one-quarter to one-third of the U.S. adult population over 8 years and is spreading to young adults and Asian and Hispanic Americans. Diagnosed when >3 out of 5 cardiometabolic risk factors are present, there is widespread agreement that its fundamental roots are in a lifestyle characterized by poor dietary quality and physical inactivity. Past lifestyle trials for MetS produce benefits that have limited sustainability, suggesting the need for new treatment approaches. METHODS This is the design and baseline cohort of the Enhancing Lifestyles in the Metabolic Syndrome (ELM) multi-site trial. The trial tests the hypothesis that a habit-based lifestyle treatment offered over 6 months, followed by 18 monthly maintenance contacts, can produce 4 new diet, physical activity, and mindfulness habits and, if so, sustained MetS remission. The design is an individually randomized, partially clustered group treatment trial of 618 participants with the MetS recruited from 5 sites in the U.S. and randomized to a small group lifestyle treatment or an enhanced standard of care education comparator. The primary outcome is MetS remission at 24 months. Secondary outcomes compare arms at 6, 15, and 24 months on MetS components, lifestyle targets, weight, body mass index, hemoglobin A1c, LDL cholesterol, medications, quality of life, psychosocial factors, and cost-effectiveness. RESULTS The cohort of 618 participants was recruited by screening 14,817 over 2.5 years (screening to enrollment ratio 24:1). Recruitment exceeded the target of 600 despite 2 COVID-19 pauses. The mean age was 55.5 years, 24.3% were male, 25.5% were a racial minority, 9.7% identified as Hispanic, and 83.0% were classified as obese (body mass index >30). The most common MetS components were abdominal obesity (97.7%) and elevated blood pressure or antihypertensive medication (86.2%). CONCLUSIONS The geographic, sociodemographic, and clinical diversity of the cohort, combined with rigorous behavioral efficacy trial methods, will provide a conclusive answer to the question of whether this habit-based lifestyle program can produce sustained 24-month remission of the MetS and thereby help to curb a significant and growing public health problem.
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Multicomponent and power training with elastic bands improve metabolic and inflammatory parameters, body composition and anthropometry, and physical function in older women with metabolic syndrome: A 20-week randomized, controlled trial.
Gargallo, P, Tamayo, E, Jiménez-Martínez, P, Juesas, A, Casaña, J, Benitez-Martinez, JC, Gene-Morales, J, Fernandez-Garrido, J, Saez, GT, Colado, JC
Experimental gerontology. 2024;:112340
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PURPOSE This study aimed to explore the effects of 20 weeks of multicomponent or power training with elastic bands (EBs) on metabolic and inflammatory blood parameters, body composition, anthropometry, and physical function in older women with metabolic syndrome (MS). METHODS Ninety participants were randomly assigned to a multicomponent (MCG; n = 30), power (PG; n = 30), or a control group (CG; n = 30). The MCG performed balance, slow-speed strength, and aerobic training, twice per week. The PG completed a high-speed resistance training program twice per week, composed of three to four sets of ten repetitions of six overall body exercises at a perceived rating of effort for the first repetition of 3-4 on the OMNI-Resistance Exercise Scale EB. MS-related variables (glucose, triglycerides, and waist circumference) and cardiometabolic risk factors (high-density lipoprotein [HDL], glycosylated hemoglobin, total cholesterol, low-density lipoprotein cholesterol [LDL], C-reactive protein, and anthropometric profile) were assessed. Physical function was evaluated through balance, strength, and mobility tests. RESULTS An analysis of variance revealed that both training groups similarly improved most glycemic and lipidic profile parameters (p ≤ 0.006; d ≥ 0.46), body composition and anthropometry (p < 0.001; d ≥ 0.41), and physical function (p ≤ 0.005; d ≥ 0.69). Opposed to the PG, the MCG improved balance (p < 0.001; d = 0.96) and decreased the inflammatory status by downregulating C-reactive protein (p = 0.003; d = 0.47). On the other hand, the PG exhibited improvements in handgrip strength (p = 0.006; d = 0.48), while the MCG did not. CONCLUSION Therefore, multicomponent and power training with EBs are plausible strategies for improving the cardiometabolic health status and physical function in older women with MS.
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Erectile dysfunction and metabolic syndrome components in obese men with psoriasis: response to a 12-week randomized controlled lifestyle modification program (exercise with diet restriction).
Ismail, AMA, Hamed, DE
Irish journal of medical science. 2024;(1):523-529
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BACKGROUND Erectile dysfunction (ED) and metabolic syndrome (MeTS) are highly prevalent in chronic plaque psoriasis (CPP). OBJECTIVE The aim of this lifestyle modification study is to explore the response of MeTS components and ED to a 12-week lifestyle modification program (low-calorie diet and moderate-intensity treadmill walking) in 60 obese men with CPP, mild and moderate ED, and MeTS. THE DESIGN, SETTINGS, PARTICIPANTS, AND INTERVENTION In this lifestyle modification randomized study, a university-based hospital recruitment of 60 obese men with CPP, mild and moderate ED, and MeTS was randomly performed. Men were randomly assigned to the lifestyle modification group (n = 30, received low-calorie diet and moderate-intensity treadmill walking programs) or waitlist group (n = 30). The following outcomes were assessed as follows: body mass index, psoriasis severity (assessed via psoriasis area and severity index), ED (assessed by the five-item internal index of erectile function), and components of MeTS (waist circumference, blood pressure, serum high-density lipoprotein, serum triglycerides, and serum fasting blood glucose). RESULTS Trends of significant improvements in all outcomes were documented in favor of the lifestyle modification group. All outcomes of the waitlist group did not show the same reported significant improvements of the lifestyle modification group. CONCLUSION A 12-week lifestyle modification program as a tool for weight loss in obese men with CPP is a good therapeutic method to improve psoriasis severity and psoriasis-associated ED and MeTS.
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The Predictive Role of Serum Lipid Levels, p53 and ki-67, According to Molecular Subtypes in Breast Cancer: A Randomized Clinical Study.
Faur, IF, Dobrescu, A, Clim, IA, Pasca, P, Prodan-Barbulescu, C, Tarta, C, Neamtu, AA, Brebu, D, Neamtu, C, Rosu, M, et al
International journal of molecular sciences. 2024;(7)
Abstract
Dyslipidemia is a component of metabolic syndrome, having an important role in the carcinogenesis of different tumor types, such as prostate, ovarian, or renal cancer. The number of studies on the predictive potential of the different components of the lipid profile with a predictive potential in breast cancer is quite low. The evaluation of the lipid profile was carried out for the 142 patients who benefited from neoadjuvant therapy (NAC) in order to identify a potential predictive biomarker. The serological sample collection was performed sequentially according to a standardized protocol, pre-NAC, post-NAC and 6 months post-NAC after a 6-h pre-collection fast. We also investigated in the general group the presence or absence of the p53 mutation (TP53) and of the mitotic index ki-67, respectively, in relation to the molecular subtypes. The menopausal status, tumor size, family history, grading, Ki-67, p53 and LN metastases have a predictive nature regarding overall survival (OS) (p < 0.05), while for disease free survival (DFS), only tumor size, tumor grading, Ki-67 > 14, and p53+ are of predictive nature. The genetic and molecular analysis carried out in our group indicates that 71.67% have a Ki-67 score higher than 14%, and 39% of the patients have the positive P53 mutation. The multivariate analysis in the case of patients included in the TNBC subtype showed that the increased tumor volume (p = 0.002) and increased level of HDL (p = 0.004) represent predictive factors for the tumor response rate to NAC. High HDL-C levels before NAC and increased LDL-C levels after NAC were associated with the better treatment response in ER-positive and HER2+ breast cancer patients. Increased HDL-C values and tumor volume represent predictive factors as to the response rate to NAC in the case of patients included in the TNBC subtype. Regarding the ER+ and HER2+ subtypes, increased levels of HDL-C pre-NAC and increased levels of LDL-C post-NAC were associated with a better therapeutic response rate. Tumor grading, Ki-67, p53, and LN metastases have a predictive nature for OS, while tumor size, tumor grading, and Ki-67 > 14, and p53+ are predictive for DFS.
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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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Impact of Brewers' Spent Grain-Containing Biscuit on Postprandial Glycaemic Response in Individuals with Metabolic Syndrome: A Crossover Randomised Controlled Trial.
Xu, Y, Leong, ZN, Zhang, W, Jin, X, Kong, JW, Chan, GCT, Kim, JE
Nutrients. 2024;(6)
Abstract
Brewers' spent grain (BSG) is a fibre and protein-rich by-product of beer-brewing. Fermenting BSG with Rhizopus oligosporus can further increase its content of soluble fibre, protein and certain antioxidants. Since nutrients rich in BSG can improve postprandial glycaemic response, this study assessed the postprandial glucose response (PPGR) and postprandial insulin response (PPIR) controlling effect of consuming 30% wheat flour substituted biscuits with autoclaved BSG (ABSG) or fermented BSG (FBSG) in individuals with metabolic syndrome (MetS). The effect on postprandial lipid panel, breath hydrogen (H2) and methane (CH4) concentration and subjective appetite response was also examined. Fifteen subjects with MetS participated in this crossover randomised controlled trial, and blood was collected at 9 time-points for 4 h after consumption of control biscuits (Control), ABSG and FBSG. A significant interaction effect was observed (Pinteraction = 0.013) for the glucose time-points concentration. At 180 min, the glucose concentration was lowered after the consumption of ABSG (p = 0.010) and FBSG (p = 0.012) compared to the Control. Moreover, the FBSG resulted in a significantly lower glucose incremental area under curve (iAUC) compared to the Control (p = 0.028). Insulin level was also lowered at 180 min after the ABSG (p = 0.010) and FBSG (p = 0.051) consumption compared to the Control. However, no difference was noted for postprandial lipid panel, breath H2 and CH4 concentration and subjective appetite response. In conclusion, the consumption of BSG-incorporated biscuits can attenuate PPGR, and fermented BSG incorporation conferred a further PPGR controlling benefit.
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The impact of leucine supplementation on body composition and glucose tolerance following energy restriction: an 8-week RCT in adults at risk of the metabolic syndrome.
Pathak, K, Zhao, Y, Calton, EK, James, AP, Newsholme, P, Sherriff, J, Soares, MJ
European journal of clinical nutrition. 2024;(2):155-162
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Abstract
BACKGROUND L-Leucine (Leu) supplementation may benefit fat-free mass (FFM) per se and glucose metabolism. OBJECTIVES To determine whether Leu supplementation during energy restriction blunted the loss of FFM, enhanced the loss of fat mass (FM) and improved glucose tolerance. DESIGN Thirty-seven adults, aged 20-65 years, with increased waist circumference and at least one other metabolic syndrome (MetS) component, were selected. We employed a two-arm parallel, double blind, randomized control trial (RCT) design. Participants were randomly assigned to an intervention group (leucine - 3 g/d) or placebo (lactose - 2.67 g/d), while following an individualised energy restricted diet for an 8-week period. Detailed body composition (DEXA), oral glucose tolerance test (OGTT), insulin and components of MetS were measured before and after the trial. Analysis of covariance (ANCOVA) assessed the effect of Leu on an intention-to-treat (ITT) principle. Bootstrapping method with 1000 bootstrap samples was used to derive parameter estimates, standard errors, p-values, and 95% confidence intervals for all outcomes. RESULTS Adjusted for baseline values and other covariates, FFM (p = 0.045) and lean tissue mass (LTM) (p = 0.050) were significantly higher following Leu. These outcomes were modified by a significant treatment x sex interaction that indicated Leu had the greater effect in men. However, on adjustment for body composition changes, there was no difference in insulin sensitivity, oral glucose tolerance, or change in MetS components following Leu. CONCLUSION Short-term leucine supplementation during energy restriction resulted in a greater preservation of FFM and LTM particularly in men, but did not impact glucose metabolism.