Effectiveness of intermittent fasting for weight loss in individuals with obesity: A meta-analysis of randomized controlled trials

AimTo assess whether intermittent fasting (IF) diets are associated with improvement in weight loss, metabolic parameters, and subjective well-being, in people with obesity.Data synthesisWe performed a Meta-analysis of Randomized Controlled Trials longer than 2 months, retrieved through an extensive search on MedLine, Cochrane CENTRAL Library, and Embase online databases, comparing weight loss with IF diets and control diets in people with Body Mass index (BMI) > 30 kg/m². We retrieved 9 trials, enrolling 540 patients. IF was not associated with a significantly greater reduction of body weight or BMI at any time point with respect to controls or in respect to continuous restricted diets, with low-to moderate quality of evidence; no significant difference in efficacy between alternate day fasting and time restricted eating was found. Differences in fasting plasma glucose, total or high-density lipoprotein cholesterol or blood pressure at any time point were not statistically significant, whereas a reduction of low-density lipoprotein cholesterol (MD −8.39 [−15.96, −0.81] mg/dl, P = 0.03; I² = 0%) was observed at 2–4 months, but not in the longer term. Data on psychological parameters and overall well-being were insufficient to perform a formal meta-analysis, whereas a qualitative synthesis did not show any difference between IF and controls.ConclusionsIF is not associated with greater or lesser weight loss than non-intermittent fasting diets. Further data on psychological parameters and overall well-being are needed to properly assess the role of IF diets in the management of obesity.     

Usefulness of a novel computer-aided detection system for colorectal neoplasia: a randomized controlled trial

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Effects of fish oil and curcumin supplementation on cerebrovascular function in older adults: A randomized controlled trial

Background and aimsChronic conditions such as obesity, which contribute to endothelial dysfunction in older adults, can cause impairments in cerebrovascular perfusion, which is associated with accelerated cognitive decline. Supplementing the diet with bioactive nutrients that can enhance endothelial function, such as fish oil or curcumin, may help to counteract cerebrovascular dysfunction.Methods and resultsA 16-week double-blind, randomized placebo-controlled trial was undertaken in 152 older sedentary overweight/obese adults (50–80 years, body mass index: 25–40 kg/m²) to investigate effects of fish oil (2000 mg docosahexaenoic acid + 400 mg eicosapentaenoic acid/day), curcumin (160 mg/day) or a combination of both on cerebrovascular function (measured by Transcranial Doppler ultrasound), systemic vascular function (blood pressure, heart rate and arterial compliance) and cardiometabolic (fasting glucose and blood lipids) and inflammatory (C-reactive protein) biomarkers. The primary outcome, cerebrovascular responsiveness to hypercapnia, was not affected by the interventions. However, cerebral artery stiffness was significantly reduced in males following fish oil supplementation (P = 0.007). Furthermore, fish oil reduced heart rate (P = 0.038) and serum triglycerides (P = 0.006) and increased HDL cholesterol (P = 0.002). Curcumin did not significantly affect these outcomes either alone or in combination with fish oil.ConclusionRegular supplementation with fish oil but not curcumin improved biomarkers of cardiovascular and cerebrovascular function. The combined supplementation did not result in additional benefits. Further studies are warranted to identify an efficacious curcumin dose and to characterize (in terms of sex, BMI, cardiovascular and metabolic risk factors) populations whose cerebrovascular and cognitive functions might benefit from either intervention.Clinical trial registrationACTRN12616000732482p.     

Effects of individualized dietary advice compared with conventional dietary advice for adults with type 2 diabetes: A randomized controlled trial

Background and aimsTo investigate the superiority of individualized dietary advice based on dietary assessment for patients with type 2 diabetes.Methods and resultsA total of 136 Japanese adults with type 2 diabetes were randomized into either individualized or conventional dietary advice groups after dietary assessment using a self-administered brief-type diet history questionnaire. Both participants received three 30-min face-to-face dietary advice sessions by dietitians at 1, 3, and 5 months from study entry. The individualized group received dietary advice based on individual dietary intakes. The conventional group received dietary advice using generalized pamphlets. The primary outcome was the change in HbA1c over 6 months, and secondary outcomes were changes in weight, serum triglyceride, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and dietary intakes. In total, 126 participants were included in the analysis. After adjustment for age, sex, and baseline measurements, HbA1c significantly decreased larger in the individualized group [?1.1%, (95% CI: ?1.3 to ?0.8)] than the conventional group [?0.7% (95% CI: ?1.0 to ?0.4)] (P = 0.0495). The individualized group significantly decreased weight, serum triglyceride, and LDL-C, and significantly increased HDL-C, without a significant difference to the conventional group. In dietary changes, the individualized group decreased intakes of energy, confectioneries, meats, oil and fats, and sugar-sweetened beverages. The conventional group decreased alcohol intake and increased total fat and saturated fatty acid intakes.ConclusionsIndividualized dietary advice among patients with type 2 diabetes was superior to conventional dietary advice in lowering HbA1c.Trial registrationUMIN000037268 (https://www.umin.ac.jp/ctr/index.htm) in July 4, 2019.     

A single center randomized double blind controlled trial of pentoxifylline in acute pancreatitis: Challenges and opportunities

ObjectivesDespite substantial morbidity and mortality associated with acute pancreatitis (AP), only one small randomized controlled drug trial (RCT) is available in the past few decades from the United States. Hence, we conducted a single-center, double-blind, placebo-controlled RCT of pentoxifylline in AP.MethodsA total of 9 doses of oral pentoxifylline 400 mg or placebo tablet, three times daily, was administered within 72 h of diagnosis, using randomization blocks by pharmacy. Primary outcome was a composite outcome including any of the following: death, peripancreatic and/or pancreatic necrosis, infected pancreatic necrosis, persistent organ failure, persistent systemic inflammatory response syndrome, hospital stay longer than 4 days, need for intensive care, and need for intervention for necrosis.ResultsBetween July 7, 2015, and April 4, 2017, we identified 685 patients with AP, 233 met eligibility criteria and 176 were approached for the study. Of these, 91 (51.7%) declined and finally 45 in pentoxifylline group and 38 in placebo group (83 total) were compared. There were no significant differences in primary outcome (27 [60.0%] vs 15 [39.5%]; P = .06). Pentoxifylline group was not associated with any benefit, but withlonger stay (42% vs. 21%; P = .04) and higher readmission rates (16 %vs 3%; P = .047).ConclusionsWe could not demonstrate superiority of pentoxifylline over placebo. Smaller sample size and inclusion of all types of severity might be the reasons for lack of efficacy. The challenges observed in the present study indicate that, in order to conduct a successful drug trial in AP, a multi center collaboration is essential.     

Covered versus uncovered double bare self-expandable metal stent for palliation of unresectable extrahepatic malignant biliary obstruction: a randomized controlled multicenter trial

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Enhanced expression of Galectin-3 in gestational diabetes

Background and aimsGestational diabetes mellitus (GDM), hyperglycemia diagnosed during pregnancy, is one of the most common medical complications of pregnancy, treated primarily by diet and pharmacotherapy, if indicated. It is well-established that GDM increases the risk of adverse pregnancy outcomes and long-term complications in mothers and infants. Galectin-3 (Gal-3) is important in processes of cell growth, differentiation, inflammation, and fibrosis. We evaluated Gal-3 expression in pregnancies complicated by GDM as a parameter that might explain how GDM influences early onset of future complications.Methods and resultsForty-four women with GDM and 40 with normal pregnancy (NP) were recruited during delivery admission. Blood samples were obtained from parturients and umbilical cords blood, as well as placental tissue for analysis. Gal-3 mRNA expression was increased in maternal blood samples and placental tissue of women with GDM compared to NP. In GDM, Gal-3 mRNA was decreased in cord blood compared to maternal blood and placental tissue. Gal-3 GDM placental protein expression was increased compared to NP. Immunostaining revealed that Gal-3 is upregulated in GDM placental extravillous trophoblast. ELISA of Gal-3 maternal serum levels between GDM and NP were similar.ConclusionGal-3 is strongly expressed at molecular levels (mRNA and protein expression) in GDM maternal blood and placental tissue, and decreased in cord blood. These findings highlight the role of the placenta in protecting the fetus from potential Gal-3 damage. Gal-3 expression at mRNA and protein levels might be influenced by diabetes, even if blood glucose is balanced by medication or diet.     

Comparing a conventional and a spring-and-loop with clip traction method of endoscopic submucosal dissection for superficial gastric neoplasms: a randomized controlled trial (with videos)

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The importance of glycemic index on post-prandial glycaemia in the context of mixed meals: A randomized controlled trial on pasta and rice

Background and aimsPost-prandial glycemic response (PPGR) depends on the intrinsic characteristic of the carbohydrate-rich foods as well as on the amount and type of other nutrients. This study aimed to explore whether the addition of condiments can affect the difference in PPGR between a low and a medium–high Glycemic Index (GI) food.Methods and resultsSpaghetti (S) and rice ® were consumed plain and after adding tomato sauce and extra virgin olive oil (TEVOO), or pesto sauce (P). The GI of R (63 ± 3) was statistically higher than that of S (44 ± 7) (p = 0.003). The Incremental Area Under the Curve (IAUC) for R was significantly greater than S (124.2 ± 12.1 and 82.1 ± 12.9 mmol1min/L respectively) (p = 0.016) for blood glucose but not for insulin (1192.6 ± 183.6 and 905.2 ± 208.9 mU1min/L, respectively) (p = 0.076). There were no significant differences after the addition of either TEVOO or P. The postprandial peaks of blood glucose and insulin for R (6.7 ± 0.3 mmol/L and 36.4 ± 4.9 mU/L, respectively) were significantly higher compared to S (6.0 ± 0.2 mmol/L and 26.7 ± 3.6 mU/L, respectively) (p = 0.033 and p = 0.025). The postprandial peak for insulin remained significantly higher with P (36.8 ± 3.7 and 28.6 ± 2.9 mU/L for R + P and S + P, p = 0.045) but not with EVOO (p = 0.963). Postprandial peaks for blood glucose were not significantly different with condiment.ConclusionsThe differences in PPGR were significant between spaghetti and rice consumed plain, they reduced or disappeared with fat adding, depending on the type of condiment used.Registration number(www.clinicaltrial.gov):NCT03104712;     

Dose-dependent efficacy and safety of licogliflozin on obese adults: A systematic review and meta-analysis of randomized controlled trials

Background and aimLicogliflozin is a dual SGLT1/2 inhibitor acting on the intestine and kidney by reducing glycemic and calorie content. We aimed to determine the efficacy and safety of licogliflozin on Anthropometric measurements and cardiometabolic parameters in obese participants.MethodsWe systematically searched the PubMed, Cochrane Library, Scopus, and Web of Science databases for randomized controlled trials (RCTs) relevant to our eligibility criteria. We performed a subgroup analysis based on licogliflozin doses and the diabetic state of participants. This meta-analysis was registered on PROSPERO (CRD42021286936).ResultsWe identified five RCTs with a total of 905 obese and overweight participants. All participants had a weight reduction of 2.43 kg (95% CI: ?3.17 to ?1.69, p < 0.00001) compared with placebo. The mean difference in HbA1c of obese diabetic patients was (MD: ?0.30%; 95% CI: ?0.45, ?0.16); I2 = 46% in favor of licogliflozin. The incidence of serious adverse events, all-cause mortality, headache, nausea, and vomiting were similar between licogliflozin and placebo (p = 0.72, 0.97, 0.09, 0.53, and 0.89, respectively). However, there was a higher incidence of diarrhea in the licogliflozin group.ConclusionWe found that licogliflozin was safe and tolerable. It reduces body weight significantly. Moreover, it improves glycemic control and other cardiometabolic parameters.     

Effect of cherry consumption on blood pressure: a systematic review and meta-analysis of randomized controlled trials

Background and aimsThe present systematic review and meta-analysis aimed to summarize the findings of randomized controlled trials (RCTs) evaluating the effect of tart and sweet cherries on systolic and diastolic blood pressure (SBP and DBP).MethodsPubMed, Scopus, Embase, and Web of Science were searched to acquire the RCTs up to December 2020.ResultsSeven RCTs comprising 201 participants were included. The meta-analysis showed that cherry supplementation does not lead to a significant decrease in SBP or DBP.ConclusionsIncorporating cherries into the diet has no significant effect on blood pressure.     

Galectin-3 Levels and Outcomes After Myocardial Infarction: A Population-Based Study

BackgroundGalectin-3 (Gal-3) is implicated in cardiac fibrosis, but its association with adverse outcomes after myocardial infarction (MI) is unknown.ObjectivesThe purpose of this study was to examine the prognostic value of Gal-3 in a community cohort of incident MI.MethodsA population-based incidence MI cohort was prospectively assembled in Olmsted County, Minnesota, between 2002 and 2012. Gal-3 levels were measured at the time of MI. Patients were followed for heart failure (HF) and death.ResultsA total of 1,342 patients were enrolled (mean age 67.1 years; 61.3% male; 78.8% non–ST-segment elevation MI). Patients with elevated Gal-3 were older and had more comorbidities. Over a mean follow-up of 5.4 years, 484 patients (36.1%) died and 368 (27.4%) developed HF. After adjustment for age, sex, comorbidities, and troponin, patients with Gal-3 values in tertiles 2 and 3 had a 1.3-fold (95% confidence interval [CI]: 0.9-fold to 1.7-fold) and a 2.4-fold (95% CI: 1.8-fold to 3.2-fold) increased risk of death, respectively (p_trend < 0.001) compared with patients with Gal-3 values in tertile 1. Patients with Gal-3 values in tertiles 2 and 3 had a higher risk of HF with hazard ratios of 1.4 (95% CI: 1.0 to 2.0) and 2.3 (95% CI: 1.6 to 3.2), respectively (p_trend < 0.001). With further adjustment for soluble suppression of tumorigenicity-2, elevated Gal-3 remained associated with increased risk of death and HF. The increased risk of HF did not differ by HF type and was independent of the occurrence of recurrent MI.ConclusionsGal-3 is an independent predictor of mortality and HF post-MI. These findings suggest a role for measuring Gal-3 levels for risk stratification post-MI.     

Low-dose l-isoproterenol versus salbutamol in hospitalized pediatric patients with severe acute exacerbation of asthma: A double-blind,randomized controlled trial

BackgroundAlthough the guidelines in most countries do not recommend continuous inhalation of l-isoproterenol to treat pediatric patients with acute severe exacerbation of asthma, lower dose of l-isoproterenol has been widely used in Japan. To determine whether the efficacy of low-dose l-isoproterenol was superior to that of salbutamol, we conducted a double-blind, randomized controlled trial.MethodsHospitalized patients aged 1–17 years were eligible if they had severe asthma exacerbation defined by the modified pulmonary index score (MPIS). Patients were randomly assigned (1:1) to receive inhalation of l-isoproterenol (10 μg/kg/h) or salbutamol (500 μg/kg/h) for 12 hours via a large-volume nebulizer with oxygen. The primary outcome was the change in MPIS from baseline to 3 hours after starting inhalation. Trial registration number UMIN000001991.ResultsFrom December 2009 to October 2013, 83 patients (42 in the l-isoproterenol group and 41 in the salbutamol group) were enrolled into the study. Of these, one patient in the l-isoproterenol group did not receive the study drug and was excluded from the analysis. Compared with salbutamol, l-isoproterenol reduced MPIS more rapidly. Mean (SD) changes in MPIS at 3 hours were −2.9 (2.5) in the l-isoproterenol group and −0.9 (2.3) in the salbutamol group (difference −2.0, 95% confidence interval −3.1 to −0.9; P < 0.001). Adverse events occurred in 1 (2%) and 11 (27%) patients in the l-isoproterenol and salbutamol groups, respectively (P = 0.003). Hypokalemia and tachycardia occurred only in the salbutamol group.ConclusionsLow-dose l-isoproterenol has a more rapid effect with fewer adverse events than salbutamol.     

Effects of nut consumption on blood lipid profile: A meta-analysis of randomized controlled trials

Background & aimsSeveral randomized controlled trials (RCTs) have assessed the effects of nut consumption on blood lipid profile. The aim of this study was to conduct a meta-analysis to quantitatively estimate the effects of nut consumption on blood lipid profile.Methods and resultsThe PubMed, EMBASE, Cochrane Library, and Google Scholar databases were systematically searched to identify RCTs examining the effects of nut intake on blood total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TGs) from inception until March 2021. A random-effects model was used to pool standardized mean differences (SMDs) and 95% confidence intervals (CIs). Potential publication bias was assessed using Begg's test and Egger's test. Sensitivity analysis was performed to assess the impact of each individual study on the pooled results. The meta-analysis showed that nut consumption had no significant effect on the blood lipid profile. However, there was a significant reduction in TC (SMD: ?2.89, 95% CI: ?4.80, ?0.98, I² = 97.4) for pistachio consumption, and cashew consumption significantly increased HDL-C (SMD: 0.24, 95% CI: 0.04, 0.43, I² = 0.0) compared with that in controls. There was no significant publication bias in the meta-analysis. The sensitivity analysis showed that removing one study at a time did not change the significance of the results.ConclusionThere was no overall effect of nut consumption on lipid profile, and the results may vary depending on nut type. We found that pistachio consumption may reduce TC levels, while cashew consumption increases HDL-C.Registry numberPROSPERO CRD42021249147.     

Negative pressure wound therapy in grade 1 and 2 diabetic foot ulcers: A randomized controlled study

Background and aimsFoot ulcers are one of the major causes of morbidity and mortality among diabetics in India. Early diagnosis and timely management is vital in preventing the progression of the disease which may require amputation. Conventional methods take a long time for healing. This study aims to compare negative pressure wound therapy (NPWT) and conventional saline dressings in diabetic foot ulcer (DFU) healing.MethodsThis prospective randomized study was conducted in 45 patients with grade 1 and 2 DFUs. 22 patients in group A received NPWT and 23 patients in group B received saline dressings. The formation of granulation tissue, reduction in ulcer size, duration of hospital stay and time for complete healing of wounds were assessed.ResultsThe formation of granulation tissue (91.14 vs 52.61%, p < 0.001) and reduction in ulcer size (40.78 vs 21.18%, p = 0.008) at 14 days was significantly more in group A. The duration of hospital stay (15.68 vs 29.00 days, p < 0.001) and time for 100% coverage of the wound with granulation tissue (14.82 ± 7.30 vs 44.57 ± 7.11 days, p < 0.001) was significantly less in group A. Complete healing of wounds at 3 months was observed in 20 patients (90.9%) in group A and 6 patients (26.1%) in group B (p = 0.006).ConclusionIn our study NPWT led to early reduction in ulcer size, more granulation tissue formation, shorter hospital stay and complete wound healing. In lower and middle income countries like India with high prevalence of DFUs, early recovery is a boon to the patients to resume their daily activities.     

Effects of dairy products consumption on inflammatory biomarkers among adults: A systematic review and meta-analysis of randomized controlled trials

AimsThis study aimed to summarize earlier studies on the effects of dairy consumption on inflammatory biomarkers in adults and to quantify these effects through meta-analysis.Data synthesisA comprehensive search of all relevant articles, published up to December 2019 indexed in PubMed, ISI (Institute for Scientific Information), EmBase, Scopus, and Google Scholar was done using relevant keywords. Randomized controlled trials (RCTs) that examined the effect of dairy products consumption, compared with low or no dairy intake, on inflammatory biomarkers in adults were included. Overall, 11 RCTs with 663 participants were included in this meta-analysis. We found that high consumption of dairy products, compared with low or no dairy intake, might significantly reduce CRP [weighed mean difference (WMD): −0.24 mg/L; 95% CI, −0.35, −0.14], TNF-α (WMD:- 0.66 pg/mL; 95% CI, −1.23, −0.09), IL-6 (WMD: −0.74 pg/mL; 95% CI, −1.36, −0.12), and MCP concentrations (WMD: −25.58 pg/mL; 95% CI, −50.31, −0.86). However, when the analyses were confined to cross-over trials, no such beneficial effects of dairy intake on inflammation were observed. In addition, high dairy intake might result in increased adiponectin levels (WMD: 2.42 μg/mL; 95% CI, 0.17, 4.66). No significant effect of dairy consumption on serum leptin (WMD: −0.32 ng/mL; 95% CI, −3.30, 2.65), ICAM-1 (WMD: −3.38 ng/ml; 95% CI, −15.57, 8.96) and VCAM-1 (WMD: 3.1 ng/mL; 95% CI, −21.38, 27.58) levels was observed.ConclusionsIn summary, the current meta-analysis indicated that dairy intake might improve several inflammatory biomarkers in adults. In most subgroups without heterogeneity, effects tended to be null. Study design and participants’ age were the main sources of heterogeneity. More research, with a particular focus on fat content of dairy foods, is recommended.