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1.
Effects of cashew nut consumption on body composition and glycemic indices: A meta-analysis and systematic review of randomized controlled trials.
Jamshidi, S, Moradi, Y, Nameni, G, Mohsenpour, MA, Vafa, M
Diabetes & metabolic syndrome. 2021;(2):605-613
Abstract
BACKGROUND AND AIMS Present meta-analysis and systematic review was conducted to synthesis a definitive conclusion from previous randomized controlled clinical trials (RCTs). METHODS A comprehensive search was done up to July 2020, in order to extract RCTs which investigated the effect of cashew nut on weight, body mass index (BMI), waist circumference (WC), fasting blood sugar (FBS), insulin, and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). Weighted mean difference (WMD) and 95% confidence interval (CI) were used to estimate effect size. Meta regression analysis was done to identify probable sources of heterogeneity. RESULTS Six clinical trials with 521 participants were included. Combined effect sizes demonstrated no effect of cashew consumption on weight (WMD): 0.02, 95% CI: -1.04, 1.09, P > 0.05), BMI (WMD: 0.1, 95% CI: -0.72, 0.74, P > 0.05), and WC (WMD: -0.13, 95% CI: -1.97, 1.70, P > 0.05). Results were also not significant for FBS (WMD: 3.58, 95% CI: -3.92, 11.08, P > 0.05), insulin (WMD: -0.19, 95% CI: -1.63, 1.25, P > 0.05), and HOMA-IR (WMD: 0.25, 95% CI: -0.55, 1.06, P > 0.05). CONCLUSION The sum up, incorporating cashew into the diet has no significant effect on body composition or modifying glycemic indices.
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Cardiovascular Outcomes with SGLT-2 inhibitors in patients with heart failure with or without type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials.
Singh, AK, Singh, R
Diabetes & metabolic syndrome. 2021;(1):351-359
Abstract
BACKGROUND AND AIMS We conducted a systematic review and meta-analysis of all the randomized controlled trials (RCTs) with SGLT-2 inhibitors (SGLT-2i) in patients with known heart failure (HF) with or without type 2 diabetes (T2DM), that have studied the outcomes of cardiovascular (CV) death, hospitalization due to HF (HHF), and composite of CV death or HHF. METHODS A systematic search in PubMed, Embase and Cochrane Library database were made up till November 20, 2020 using specific keywords. RCTs that qualified underwent a meta-analysis by applying the inverse variance-weighted averages of pooled logarithmic hazard ratio (HR) using both random- and fixed-effects model. RESULTS This meta-analysis of 9 RCTs (N = 19,741) have found a significant 26% relative risk reduction in composite of CV death or HHF (HR 0.74; 95% CI, 0.69-0.79; p < 0.001) with SGLT-2i in patients with HF. The meta-analysis of 8 RCTs (N = 16,460) also showed a significant reduction in CV death (HR 0.86; 95% CI, 0.78-0.95; p = 0.003) and HHF (HR 0.68; 95% CI, 0.62-0.74; p < 0.001) outcomes with SGLT-2i in patients with HF. Subgroup analysis stratified on baseline ejection fraction (EF) showed a similar benefit in the composite of CV death or HHF in patients with HF with reduced EF (HFrEF) or preserved EF (HFpEF). CONCLUSIONS SGLT-2i significantly reduces the composite of CV death or HHF, CV death, and HHF in patients with HF. Although subgroup analysis suggested an insignificant Pheterogenity for these outcomes irrespective of the types of HF, however, reduction in both CV death and HHF were more pronounced in patients with HFrEF.
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Effect of saffron supplementation on liver enzymes: A systematic review and meta-analysis of randomized controlled trials.
Hasani, M, Malekahmadi, M, Rezamand, G, Estêvão, MD, Pizarro, AB, Heydari, H, Hoong, WC, Arafah, OA, Barakeh, ARR, Rahman, A, et al
Diabetes & metabolic syndrome. 2021;(6):102311
Abstract
BACKGROUND AND AIMS Possible protective effects of saffron (Crocus sativus L) have been reported in several randomized clinical trials (RCTs). Current systematic review was performed to summarize the efficacy of saffron intake on liver enzymes. METHODS An electronic database search was conducted on PubMed/Medline, Scopus, Web of Science, and Cochrane for RCTs comparing effect of saffron and placebo on liver enzymes from inception to July 2021. There was no restriction in language of included studies and we calculated the standardized mean difference (SMD) and 95% Confidence Intervals (CI) for each variable. Random-effect model was used to calculate effect size. RESULTS Eight studies (n = 463 participants) were included in the systematic review. The saffron intake was associated with a statistically significant decrease in aspartate aminotransferase (AST) (SMD: -0.18; 95% CI: -0.34, -0.02; I2 = 0%) in comparison to placebo intake. Our results also indicated that saffron consumption did not have a significant effect on alanine aminotransferase (ALT) (SMD: -0.14; 95% CI: -0.36, 0.09; I2 = 47.0%) and alkaline phosphatase (ALP) levels (SMD: 0.14; 95% CI: -0.18, 0.46; I2 = 42.9%) compared to placebo. CONCLUSIONS Saffron intake showed beneficial impacts on circulating AST levels. However, larger well-designed RCTs are still needed to clarify the effect of saffron intake on these and other liver enzymes.
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Hiding unhealthy heart outcomes in a low-fat diet trial: the Women's Health Initiative Randomized Controlled Dietary Modification Trial finds that postmenopausal women with established coronary heart disease were at increased risk of an adverse outcome if they consumed a low-fat 'heart-healthy' diet.
Noakes, TD
Open heart. 2021;(2)
Abstract
The Women's Health Initiative Randomized Controlled Dietary Modification Trial (WHIRCDMT) was designed to test whether the US Department of Agriculture's 1977 Dietary Guidelines for Americans protects against coronary heart disease (CHD) and other chronic diseases. The only significant finding in the original 2006 WHIRCDMT publication was that postmenopausal women with CHD randomised to a low-fat 'heart-healthy' diet in 1993 were at 26% greater risk of developing additional CHD events compared with women with CHD eating the control diet. A 2017 WHIRCDMT publication includes data for an additional 5 years of follow-up. It finds that CHD risk in this subgroup of postmenopausal women had increased further to 47%-61%. The authors present three post-hoc rationalisations to explain why this finding is 'inadmissible': (1) only women in this subgroup were less likely to adhere to the prescribed dietary intervention; (2) their failure to follow the intervention diet increased their CHD risk; and (3) only these women were more likely to not have received cholesterol-lowering drugs. These rationalisations appear spurious. Rather these findings are better explained as a direct consequence of postmenopausal women with features of insulin resistance (IR) eating a low-fat high-carbohydrate diet for 13 years. All the worst clinical features of IR, including type 2 diabetes mellitus (T2DM) in some, can be 'reversed' by the prescription of a high-fat low-carbohydrate diet. The Women's Health Study has recently reported that T2DM (10.71-fold increased risk) and other markers of IR including metabolic syndrome (6.09-fold increased risk) were the most powerful predictors of future CHD development in women; blood low-density lipoprotein-cholesterol concentration was a poor predictor (1.38-fold increased risk). These studies challenge the prescription of the low-fat high-carbohydrate heart-healthy diet, at least in postmenopausal women with IR, especially T2DM. According to the medical principle of 'first do no harm', this practice is now shown to be not evidence-based, making it scientifically unjustifiable, perhaps unethical.
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The Effects of Resveratrol Supplementation in Overweight and Obese Humans: A Systematic Review of Randomized Trials.
Christenson, J, Whitby, SJ, Mellor, D, Thomas, J, McKune, A, Roach, PD, Naumovski, N
Metabolic syndrome and related disorders. 2016;(7):323-33
Abstract
BACKGROUND Obesity and metabolic syndrome are significant global health issues, with current public health messages predominately focused on altering dietary and physical activity behaviors. Resveratrol is a polyphenol (stilbenoid) commonly found in grapes, and human trials to date have shown conflicting and limited beneficial effects with respect to health. The aim of this study was to determine the effect of resveratrol supplementation on reducing body weight and modifying associated inflammatory markers. METHODS A systematic review was undertaken following the PRISMA guidelines and using five indexed databases (OVID MEDLINE, Cochrane Library, Web of Science, SCOPUS, and CINAHL). A search strategy was formulated to select randomized, double-blind, placebo-controlled human trials investigating the effects of resveratrol supplementation on obesity or overweight, including body weight, metabolic and inflammatory markers. RESULTS Five thousand five hundred sixty-nine studies published from 1990 to November 2015 were identified, with only nine papers meeting the inclusion criteria. The studies involved 208 participants (aged 49.2 ± 8.3 years) and utilized a substantial range of resveratrol doses (75-3000 mg/day). Study durations were a minimum of 2 weeks (14-90 days). Seven studies indicated no significant change in body mass index or body weight (P > 0.05), and three studies showed no improvements in fat mass, fat volume, or abdominal fat distribution (P > 0.05). Four studies included measurements of inflammatory markers, with three of these finding resveratrol supplementation to have a significant positive effect (P > 0.05). CONCLUSION Based on the included studies, there is currently insufficient evidence to support the recommendation of resveratrol supplements in management of obesity. However, there were significant but not entirely consistent anti-inflammatory effects after resveratrol supplementation in overweight and obese individuals.
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Mediterranean diet and weight loss: meta-analysis of randomized controlled trials.
Esposito, K, Kastorini, CM, Panagiotakos, DB, Giugliano, D
Metabolic syndrome and related disorders. 2011;(1):1-12
Abstract
BACKGROUND The epidemiological evidence supporting a causal link between Mediterranean diets and body weight is contrasting. We evaluated the effect of Mediterranean diets on body weight in randomized controlled trials (RCTs) using a meta-analysis. METHODS We searched English and non-English publications in PubMed, Embase, Scopus, and the Cochrane Central Register of Controlled Trials from inception to January, 2010. Two evaluators independently selected and reviewed eligible studies. Sixteen randomized controlled trials, with 19 arms and 3,436 participants (1,848 assigned to a Mediterranean diet and 1,588 assigned to a control diet) were included. RESULTS In a random-effects meta-analysis of all 19 arms, the Mediterranean diet group had a significant effect on weight [mean difference between Mediterranean diet and control diet, -1.75 kg; 95% confidence interval (CI), -2.86 to -0.64 kg] and body mass index (mean difference, -0.57 kg/m², -0.93 to -0.21 kg/m²). The effect of Mediterranean diet on body weight was greater in association with energy restriction (mean difference, -3.88 kg, -6.54 to -1.21 kg), increased physical activity (-4.01 kg, -5.79 to -2.23 kg), and follow up longer than 6 months (-2.69 kg, -3.99 to -1.38 kg). No study reported significant weight gain with a Mediterranean diet. CONCLUSIONS Mediterranean diet may be a useful tool to reduce body weight, especially when the Mediterranean diet is energy-restricted, associated with physical activity, and more than 6 months in length. Mediterranean diet does not cause weight gain, which removes the objection to its relatively high fat content. These results may be useful for helping people to lose weight.
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Baseline characteristics of participants in the Hypertension in the Very Elderly Trial (HYVET).
Bulpitt, CJ, Beckett, NS, Peters, R, Banya, W, Liu, L, Wang, JG, Stoyanovsky, V, Dumitrascu, D, Nikitin, Y, Staessen, JA, et al
Blood pressure. 2009;(1-2):17-22
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Abstract
The Hypertension in the Very Elderly Trial (HYVET) is a randomized double-blind trial of active antihypertensive treatment (indapamide 1.5 mg sustained release +/-2-4 mg perindopril) vs placebo in participants over the age of 80 years with a systolic blood pressure (SBP) of 160-199 mmHg during a placebo run-in period plus a diastolic blood pressure (DBP) of<110 mmHg. The trial has completed with 3845 subjects randomized and we report the baseline characteristics. The participants were a healthy group. The numbers smoking, drinking alcohol and having previous cardiovascular events were low, and their hypertensive status was not usually associated with the metabolic syndrome; 1.0% of the whole group had a total cholesterol over 8.0 mmol/l, 1.1% a blood sugar over 11.1 mmol/l (irrespective of anti-diabetic treatment) and 1.7% a serum urate over 460 micromol/l (women) and 0.6% over 520 micromol/l (men). A serum creatinine over 150 micromol/l excluded participants from the trial. The gender differences and age comparisons were as expected but the women had higher average total and high-density-lipoprotein-cholesterol blood concentrations. Those with prior cardiovascular disease had an excess of the known cardiovascular risk factors. The baseline characteristics provide a basis for further understanding of the HYVET results, which have been published recently.
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Dose Response to Exercise in Women aged 45-75 yr (DREW): design and rationale.
Morss, GM, Jordan, AN, Skinner, JS, Dunn, AL, Church, TS, Earnest, CP, Kampert, JB, Jurca, R, Blair, SN
Medicine and science in sports and exercise. 2004;(2):336-44
Abstract
INTRODUCTION AND PURPOSE Physical inactivity in postmenopausal women contributes to a rise in atherogenic risk factors associated with the metabolic syndrome. Although regular physical activity positively contributes to health, inactivity progressively increases with age. The Dose Response to Exercise in Women aged 45-75 yr (DREW) study is designed to investigate the effect of different amounts of exercise training on cardiorespiratory fitness and risk factors for cardiovascular disease (CVD) in postmenopausal women at moderately increased risk of CVD. METHODS DREW will recruit 450 sedentary, healthy, postmenopausal women with a body mass index of 25-40 kg.m-2, resting systolic blood pressure (BP) of 120-159 mm Hg, and a resting diastolic BP of < or = 99 mm Hg. Laboratory and self-report measures completed at baseline and 6 months include maximal oxygen consumption (.VO2max), resting BP, anthropometry, dietary habits, physical activity history, medication use, menstrual history, personal and family medical history, and fasting HDL cholesterol, LDL cholesterol, triglycerides, and glucose. Eligible participants are randomly assigned to a nonexercise group or one of three exercise groups. Participants exercise 3 to 4x wk-1 at a heart rate equivalent to 50% of .VO2max expending 4, 8, or 12 kcal.kg-1.wk-1, depending on group assignment. This study will allow quantification of possible dose-response relations (50%, 100%, and 150% of the consensus physical activity recommendation) between exercise training and study outcomes. CONCLUSION DREW can make important contributions to our understanding of the effects of physical activity in postmenopausal women and help refine public health and clinical recommendations for this group.