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Effectiveness of a Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study).
Represas-Carrera, F, Couso-Viana, S, Méndez-López, F, Masluk, B, Magallón-Botaya, R, Recio-Rodríguez, JI, Pombo, H, Leiva-Rus, A, Gil-Girbau, M, Motrico, E, et al
International journal of environmental research and public health. 2021;18(11)
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Life habits such as smoking, physical activity, and diet affect glycaemic control. The objective of this multicentre randomised cluster trial (EIRA study) was to evaluate the effectiveness of multicomponent educational interventions on glycaemic control in Type 2 diabetic patients. Interventions in multicomponent individual, group and community settings included smoking cessation, the Mediterranean diet and physical activity, as well as an assessment of the quality of life. Participants had unhealthy lifestyles prior to the intervention. The study was conducted in 26 primary healthcare centres in seven health departments in Spain over a period of 12 months. A brief intervention aimed to change the habits of the participants, including increasing physical activity, quitting smoking and adhering to the Mediterranean diet. After 12 months of intervention, there were no statistically significant improvements in glycaemic control, physical activity, sedentary lifestyle, smoking, or quality of life. However, adherence to the Mediterranean diet was statistically significant. Further research is needed to determine the effectiveness of multicomponent interventions in improving glycaemic control. The clinical applicability of multicomponent interventions to tackle type 2 diabetes, obesity, and unhealthy lifestyles should be considered by healthcare providers.
Abstract
Introduction: We evaluated the effectiveness of an individual, group and community intervention to improve the glycemic control of patients with diabetes mellitus aged 45-75 years with two or three unhealthy life habits. As secondary endpoints, we evaluated the inverventions' effectiveness on adhering to Mediterranean diet, physical activity, sedentary lifestyle, smoking and quality of life. Method: A randomized clinical cluster (health centers) trial with two parallel groups in Spain from January 2016 to December 2019 was used. Patients with diabetes mellitus aged 45-75 years with two unhealthy life habits or more (smoking, not adhering to Mediterranean diet or little physical activity) participated. Centers were randomly assigned. The sample size was estimated to be 420 people for the main outcome variable. Educational intervention was done to improve adherence to Mediterranean diet, physical activity and smoking cessation by individual, group and community interventions for 12 months. Controls received the usual health care. The outcome variables were: HbA1c (main), the Mediterranean diet adherence score (MEDAS), the international diet quality index (DQI-I), the international physical activity questionnaire (IPAQ), sedentary lifestyle, smoking ≥1 cigarette/day and the EuroQuol questionnaire (EVA-EuroQol5D5L). Results: In total, 13 control centers (n = 356) and 12 intervention centers (n = 338) were included with similar baseline conditions. An analysis for intention-to-treat was done by applying multilevel mixed models fitted by basal values and the health center: the HbA1c adjusted mean difference = -0.09 (95% CI: -0.29-0.10), the DQI-I adjusted mean difference = 0.25 (95% CI: -0.32-0.82), the MEDAS adjusted mean difference = 0.45 (95% CI: 0.01-0.89), moderate/high physical activity OR = 1.09 (95% CI: 0.64-1.86), not living a sedentary lifestyle OR = 0.97 (95% CI: 0.55-1.73), no smoking OR = 0.61 (95% CI: 0.54-1.06), EVA adjusted mean difference = -1.26 (95% CI: -4.98-2.45). Conclusions: No statistically significant changes were found for either glycemic control or physical activity, sedentary lifestyle, smoking and quality of life. The multicomponent individual, group and community interventions only showed a statistically significant improvement in adhering to Mediterranean diet. Such innovative interventions need further research to demonstrate their effectiveness in patients with poor glycemic control.
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Serological investigation of IgG and IgE antibodies against food antigens in patients with inflammatory bowel disease.
Wang, HY, Li, Y, Li, JJ, Jiao, CH, Zhao, XJ, Li, XT, Lu, MJ, Mao, XQ, Zhang, HJ
World journal of clinical cases. 2019;7(16):2189-2203
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Crohn's disease and ulcerative colitis are relapsing gut inflammatory diseases that are usually referred to as Inflammatory Bowel Disease (IBD). It may be triggered by an imbalance in immune response in response to environmental factors such as diet. The aim of this retrospective study was to evaluate the presence of IgG and IgE mediated antibodies to food antigens in IBD patients. There were one hundred and thirty-seven IBD patients participating in this study, including forty Ulcerative colitis patients and ninety-seven Crohn's disease patients against fifty healthy controls to test serum IgG antibodies to fourteen specific food antigens and serum IgE antibodies to fourteen specific food antigens. There were significantly higher IgG antibodies in response to food antigens in Crohn's disease patients than in Ulcerative colitis patients and healthy controls. Food antigens such as tomato, corn, egg, rice, and soybean exhibited varying levels of IgG antibody responses in Crohn's disease patients and ulcerative colitis patients. Smokers were more likely to develop IgG reactions. Further robust research is needed to examine more IgG-specific food antigens to help manage IBD with an elimination rotation diet. The results of this study can help healthcare professionals understand the importance of diagnosing food intolerances when treating IBD.
Abstract
BACKGROUND Food antigens have been shown to participate in the etiopathogenesis of inflammatory bowel disease (IBD), but their clinical value in IBD is still unclear. AIM: To analyze the levels of specific immunoglobulin G (IgG) and E (IgE) antibodies against food antigens in IBD patients and to determine their clinical value in the pathogenesis of IBD. METHODS We performed a retrospective study based on patients who visited the First Affiliated Hospital of Nanjing Medical University between August 2016 and January 2018. A total of 137 IBD patients, including 40 patients with ulcerative colitis (UC) and 97 patients with Crohn's disease (CD), and 50 healthy controls (HCs), were recruited. Serum food-specific IgG antibodies were detected by semi-quantitative enzyme-linked immunosorbent assay, and serum food-specific IgE antibodies were measured by Western blot. The value of food-specific IgG antibodies was compared among different groups, and potent factors related to these antibodies were explored by binary logistic regression. RESULTS Food-specific IgG antibodies were detected in 57.5% of UC patients, in 90.72% of CD patients and in 42% of HCs. A significantly high prevalence and titer of food-specific IgG antibodies were observed in CD patients compared to UC patients and HCs. The number of IgG-positive foods was greater in CD and UC patients than in HCs (CD vs HCs, P = 0.000; UC vs HCs, P = 0.029). The top five food antigens that caused positive specific IgG antibodies in CD patients were tomato (80.68%), corn (69.32%), egg (63.64%), rice (61.36%), and soybean (46.59%). The foods that caused positive specific IgG antibodies in UC patients were egg (60.87%), corn (47.83%), tomato (47.83%), rice (26.09%), and soybean (21.74%). Significantly higher levels of total food-specific IgG were detected in IBD patients treated with anti-TNFα therapy compared to patients receiving steroids and immunosuppressants (anti-TNFα vs steroids, P = 0.000; anti-TNFα vs immunosuppressants, P = 0.000; anti-TNFα vs steroids + immunosuppressants, P = 0.003). A decrease in food-specific IgG levels was detected in IBD patients after receiving anti-TNFα therapy (P = 0.007). Patients who smoked and CD patients were prone to developing serum food-specific IgG antibodies [Smoke: OR (95%CI): 17.6 (1.91-162.26), P = 0.011; CD patients: OR (95%CI): 12.48 (3.45-45.09), P = 0.000]. There was no difference in the prevalence of food-specific IgE antibodies among CD patients (57.1%), UC patients (65.2%) and HCs (60%) (P = 0.831). CONCLUSION CD patients have a higher prevalence of food-specific IgG antibodies than UC patients and HCs. IBD patients are prone to rice, corn, tomato and soybean intolerance. Smoking may be a risk factor in the occurrence of food-specific IgG antibodies. Food-specific IgG antibodies may be a potential method in the diagnosis and management of food intolerance in IBD.
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Nutraceutical approach for the management of cardiovascular risk - a combination containing the probiotic Bifidobacterium longum BB536 and red yeast rice extract: results from a randomized, double-blind, placebo-controlled study.
Ruscica, M, Pavanello, C, Gandini, S, Macchi, C, Botta, M, Dall'Orto, D, Del Puppo, M, Bertolotti, M, Bosisio, R, Mombelli, G, et al
Nutrition journal. 2019;18(1):13
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Probiotics have been shown to reduce total cholesterol (TC) and low-density lipoprotein (LDL-C – often called ‘bad’ cholesterol) in people with moderately raised cholesterol levels. A specific strain of probiotic called Bifidobacterium longum BB536, may decrease TC and LDL-C by reducing the reabsorption of cholesterol from the intestine, and, combined with other natural supplements, may be useful to manage high cholesterol in people at low risk of heart disease. This study was conducted to evaluate the effect of a nutraceutical (Lactoflorene Colesterolo®), containing Bifidobacterium longum BB536 (1bn CFUs) combined with red yeast rice (RYR) extract (10 mg/day monacolin K), niacin (16mg) and coenzyme Q10 (20mg) on levels of cholesterol and fats in the blood. This was a 12-week randomised, parallel, double-blind, placebo-controlled study, in which 33 adults at low risk of heart disease were given either the Bifidobacterium combination, or a placebo. Treatment with the Bifidobacterium combination significantly reduced total cholesterol by 16.7%, LDL-C by 25.7%, non-HDL-C by 24% and apolipoprotein-B by 17%. Triglycerides, HDL-C, apolipoprotein AI, lipoprotein (a) and proprotein convertase subtilisin/kexin type 9 (PCSK9) were unchanged. Markers of cholesterol synthesis and absorption suggested that a reduction in the synthesis of cholesterol had occurred without increased absorption of cholesterol. No adverse effects were reported in the study and the compliance rate was high at 97%. The use of nutraceuticals in the prevention of cardiovascular disease, as well as in other areas related to chronic diseases like cancer, is currently expanding.
Abstract
BACKGROUND Probiotics incorporated into dairy products have been shown to reduce total (TC) and LDL cholesterolemia (LDL-C) in subjects with moderate hypercholesterolemia. More specifically, probiotics with high biliary salt hydrolase activity, e.g. Bifidobacterium longum BB536, may decrease TC and LDL-C by lowering intestinal cholesterol reabsorption and, combined with other nutraceuticals, may be useful to manage hypercholesterolemia in subjects with low cardiovascular (CV) risk. This study was conducted to evaluate the efficacy and safety of a nutraceutical combination containing Bifidobacterium longum BB536, red yeast rice (RYR) extract (10 mg/day monacolin K), niacin, coenzyme Q10 (Lactoflorene Colesterolo®). The end-points were changes of lipid CV risk markers (LDL-C, TC, non-HDL-cholesterol (HDL-C), triglycerides (TG), apolipoprotein B (ApoB), HDL-C, apolipoprotein AI (ApoAI), lipoprotein(a) (Lp(a), proprotein convertase subtilisin/kexin type 9 (PCSK9)), and of markers of cholesterol synthesis/absorption. METHODS A 12-week randomized, parallel, double-blind, placebo-controlled study. Thirty-three subjects (18-70 years) in primary CV prevention and low CV risk (SCORE 0-1% in 24 and 2-4% in 9 subjects; LDL-C: 130-200 mg/dL) were randomly allocated to either nutraceutical (N = 16) or placebo (N = 17). RESULTS Twelve-week treatment with the nutraceutical combination, compared to placebo, significantly reduced TC (- 16.7%), LDL-C (- 25.7%), non-HDL-C (- 24%) (all p < 0.0001), apoB (- 17%, p = 0.003). TG, HDL-C, apoAI, Lp(a), PCSK9 were unchanged. Lathosterol:TC ratio was significantly reduced by the nutraceutical combination, while campesterol:TC ratio and sitosterol:TC ratio did not change, suggesting reduction of synthesis without increased absorption of cholesterol. No adverse effects and a 97% compliance were observed. CONCLUSIONS A 12-week treatment with a nutraceutical combination containing the probiotic Bifidobacterium longum BB536 and RYR extract significantly improved the atherogenic lipid profile and was well tolerated by low CV risk subjects. TRIAL REGISTRATION NCT02689934 .
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High-Carbohydrate Diets and Food Patterns and Their Associations with Metabolic Disease in the Korean Population.
Lee, YJ, Song, S, Song, Y
Yonsei medical journal. 2018;59(7):834-842
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A global increase in the prevalence of metabolic disease has led to a reassessment of healthy dietary patterns. Recent analyses have found low carbohydrate diets, primarily those with focus on a low glycaemic index, to improve metabolic function. The aim of this study was to evaluate the high-carbohydrate and low-fat dietary pattern, typical among Asian countries, and its association to metabolic diseases. This cross-sectional study included 13016 participants from the Korean National Health and Nutrition Examination Survey (KNHANES). Although overall carbohydrate consumption was high, approximately 60% of subjects had no whole grain consumption, elucidating the high dependence on refined grains in the typical Asian diet. This study found a positive association of dietary carbohydrate with metabolic disease attributed to the very-high carbohydrate diet typical in the Korean population. The authors conclude that optimum macronutrient intakes and food patterns should be explored for each country to reduce the prevalence of metabolic diseases. Further studies are required for Asian countries to better understand the role of refined carbohydrates in the progression of metabolic disease.
Abstract
PURPOSE Although an Asian diet is typically high in carbohydrate and low in fat, there has been a steady increase in the rate of cardiometabolic disease in Asian countries over the past decade. We evaluated food patterns of a high-carbohydrate diet and examined their associations with metabolic disease. MATERIALS AND METHODS Using data from the 2013-2015 Korean National Health and Nutrition Examination Survey, we included a total of 13106 subjects aged 20 years or older in this study. Diet was divided into seven groups according to the percentage of energy from carbohydrates. Food patterns were evaluated as individual servings per food group. Multivariate logistic regression was conducted to estimate odds ratios (OR) for metabolic disease. RESULTS The proportions of men and women exceeding the recommended range of carbohydrate intake were 58.0% and 60.0%, respectively. A higher carbohydrate diet was associated with intake of low energy and saturated fats, with more grains and fruit, but less meat, fish, egg, bean (MFEB), and dairy consumption. Carbohydrate intake decreased by 3.0-3.4% per serving of MFEB and milk. In men, the highest carbohydrate group showed an OR of 1.35 [95% confidence interval (CI), 0.91 to 1.99] for metabolic syndrome, although this failed to show statistical significance. In women, the highest carbohydrate group had an OR of 1.38 (95% CI, 1.06 to 1.80) for a reduced level of high-density lipoprotein cholesterol. CONCLUSION This study suggests that a very-high-carbohydrate diet for the Korean population is attributable to lower consumption of MFEB and dairy products and is associated with several metabolic risk factors. The appropriate distribution of macronutrients for the prevention and management of metabolic disease should be explored.
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Heat-stabilised rice bran consumption by colorectal cancer survivors modulates stool metabolite profiles and metabolic networks: a randomised controlled trial.
Brown, DG, Borresen, EC, Brown, RJ, Ryan, EP
The British journal of nutrition. 2017;117(9):1244-1256
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Colorectal cancer (CRC) is the third most common cancer in the world. Rice bran is high in phytochemicals, fibre and other bioactive compounds that may have potential to reduce cancer formation. Rice bran consumption has been shown to reduce CRC growth in mice, as well as alter the stool microbiome in humans. This alteration of the gut microbiome and the metabolic end products produced by it is thought to provide positive health benefits in terms of CRC development. This randomised controlled trial with CRC survivors included daily consumption of 30g/day of rice bran for 28 days in the intervention group, consisting of 9 participants. No rice bran was consumed in the control group of 10 participants. The aim of the study was to identify changes in metabolites that may have potential to reduce the risk of CRC, in the stool samples given by the participants after consuming rice bran, as well as to understand the differences in stool metabolites in the intervention and control groups. The authors found that rice bran consumption led to changes in 93 metabolites, 33 of which increased, while 60 metabolites decreased after 4 weeks of consumption. Metabolic pathways affected included advanced glycation end products, steroid metabolism, primary bile acid metabolism, leucine, isoleucine and valine metabolism, methionine, cysteine, S-adenosyl methionine and taurine metabolism, inositol metabolism, vitamin B6 metabolism and benzoate metabolism. The authors hypothesise that these metabolic changes may have potential for the prevention of cancer and they should be further explored in larger studies.
Abstract
Rice bran (RB) consumption has been shown to reduce colorectal cancer (CRC) growth in mice and modify the human stool microbiome. Changes in host and microbial metabolism induced by RB consumption was hypothesised to modulate the stool metabolite profile in favour of promoting gut health and inhibiting CRC growth. The objective was to integrate gut microbial metabolite profiles and identify metabolic pathway networks for CRC chemoprevention using non-targeted metabolomics. In all, nineteen CRC survivors participated in a parallel randomised controlled dietary intervention trial that included daily consumption of study-provided foods with heat-stabilised RB (30 g/d) or no additional ingredient (control). Stool samples were collected at baseline and 4 weeks and analysed using GC-MS and ultra-performance liquid chromatography-MS. Stool metabolomics revealed 93 significantly different metabolites in individuals consuming RB. A 264-fold increase in β-hydroxyisovaleroylcarnitine and 18-fold increase in β-hydroxyisovalerate exemplified changes in leucine, isoleucine and valine metabolism in the RB group. A total of thirty-nine stool metabolites were significantly different between RB and control groups, including increased hesperidin (28-fold) and narirutin (14-fold). Metabolic pathways impacted in the RB group over time included advanced glycation end products, steroids and bile acids. Fatty acid, leucine/valine and vitamin B6 metabolic pathways were increased in RB compared with control. There were 453 metabolites identified in the RB food metabolome, thirty-nine of which were identified in stool from RB consumers. RB consumption favourably modulated the stool metabolome of CRC survivors and these findings suggest the need for continued dietary CRC chemoprevention efforts.