Is cognitive behavioral therapy more effective than pharmacotherapy for binge spectrum disorders? A systematic review and meta-analysis.

OBJECTIVES: Binge spectrum disorders are prevalent worldwide. Psychiatric and medical comorbidities are common, and societal costs are significant. Evidence-based treatment remains underutilized. Cognitive behavioral therapy is the recommended first-line treatment, but pharmacotherapy may be easier to access. INTERVENTIONS: Meta-analytic evidence directly comparing cognitive behavioral therapy with pharmacotherapy is lacking. We aimed to compare the effects of cognitive behavioral therapy interventions with any pharmacological treatment for binge spectrum disorders. We searched PubMed, Embase, CENTRAL, ClinicalTrials.gov and reference lists for randomized controlled trials comparing cognitive behavioral therapy with any pharmacotherapy for bulimia nervosa/binge eating disorder and performed pairwise meta-analytic evaluations. PRIMARY OUTCOMES: Primary outcomes are remission and frequency of binges. Secondary outcomes are frequency of purges, response, eating disorder psychopathology, weight/body mass index, depression, anxiety, quality of life and dropouts. RESULTS: Eleven randomized controlled trials comparing cognitive behavioral therapy with fluoxetine/imipramine/desipramine/methylphenidate/sibutramine were identified (N = 531). Cognitive behavioral therapy was superior to antidepressants in terms of remission, frequency of binges and eating disorder psychopathology. There were no statistically significant differences for any of the individual cognitive behavioral therapy vs drug comparisons in terms of response/depression/anxiety/weight/quality of life/dropouts. Cognitive behavioral therapy was not superior to sibutramine/methylphenidate for the primary outcomes. CONCLUSIONS: Data are scarce, comparisons underpowered and, considering the inherent methodological limitations of psychotherapy trials, questions arise regarding the presumed superiority of cognitive behavioral therapy. Further research is needed.

Can omega-3 fatty acids be beneficial in pediatric NAFLD? A systematic review and meta-analysis.

Nonalcoholic fatty liver disease (NAFLD) has become the most common chronic liver disease in children and no medications or supplements are currently recommended. The role of omega-3 (n-3) fatty acids has been investigated in clinical trials with promising results. The aim of this study is to provide a detailed summary of the evidence about the efficacy of n-3 in the treatment of pediatric NAFLD. A systematic literature search was performed through major electronic databases up to September 20, 2021 for randomized placebo-controlled trials, investigating the efficacy of n-3 fatty acids in children with NAFLD. The primary outcomes were changes in serum transaminases concentration, Body Mass Index (BMI) and improvement of ultrasonographic liver steatosis. The secondary outcomes were changes in the patients' serum lipid profile, γ-glutamyl transferase (GGT), fasting blood glucose (FBG), homeostatic model assessment of insulin resistance (ΗΟΜΑ-ΙR) and waist circumference (WC). Results were expressed as mean differences for continuous outcomes and odds ratios for dichotomous outcomes with 95% confidence intervals. Six RCTs (n = 378 patients) were included. Treatment with n-3, compared to placebo, resulted in a statistically significant reduction in transaminases concentration. In addition, a significant improvement in liver steatosis assessed by ultrasonography and a decrease in BMI were observed. N-3 fatty acids supplementation seems to be an effective alternative treatment in pediatric NAFLD by improving liver biochemistry, ultrasonographic steatosis and BMI. Further research is required concerning the effect of n-3 fatty acids in liver histology.

Impact of COVID-19 lockdown on smoking and vaping: systematic review and meta-analysis.

OBJECTIVES: COVID-19 and the implementation of lockdowns have impacted daily lives worldwide. This systematic review and meta-analysis aimed to investigate the impact of lockdowns on the smoking and vaping behaviours of adults during the pandemic. STUDY DESIGN: This was a systematic review and meta-analysis. METHODS: A systematic literature search was conducted up to 28 April 2022 in the following databases: PubMed, Embase and Web of Science. RESULTS: In total, 77 studies met the inclusion criteria for this review. In 34 studies, an increase in smoking behaviour was reported for the majority of participants; however, in 21 and 18 studies, 'no change' and 'decrease' in smoking were the predominant responses, respectively. The results from the meta-analysis, which examined the change in the number of cigarettes smoked per day, showed no difference between the pre- and post-lockdown periods: 0.81 weighted mean difference (95% confidence interval, -0.59 to 2.21). Regarding vaping, three of seven studies reported an increase in smoking for the majority of participants, whereas 'no change' and 'decrease' were the predominant answers in the other four studies. CONCLUSIONS: The results show that lockdowns led most participants to increase smoking/vaping, whereas a decrease or cessation of smoking/vaping was only reported in the minority of participants. Attention should be given to the non-communicable diseases that could arise as a result of the increase in smoking/vaping during lockdowns, and further research in this area is needed.

Plasma Lipids Profile in the Prediction of Non-Alcoholic Steatohepatitis in Adults: A Case-Control Study.

Patients with non-alcoholic steatohepatitis (NASH) show significantly faster progress in the stages of fibrosis compared to those with non-alcoholic fatty liver (NAFL) disease. The non-invasive diagnosis of NASH remains an unmet clinical need. Preliminary data have shown that sphingolipids, especially ceramides, fatty acids, and other lipid classes may be related to the presence of NASH and the histological activity of the disease. The aim of our study was to assess the association of certain plasma lipid classes, such as fatty acids, acylcarnitines, and ceramides, with the histopathological findings in patients with NASH. The study included three groups: patients with NASH (N = 12), NAFL (N = 10), and healthy [non non-alcoholic fatty liver disease (NAFLD)] controls (N = 15). Plasma samples were collected after 12 h of fasting, and targeted analyses for fatty acids, acylcarnitines, and ceramides were performed. Baseline clinical and demographic characteristics were collected. There was no significant difference in baseline characteristics across the three groups or between NAFL and NASH patients. Patients with NASH had increased levels of several fatty acids, including, among others, fatty acid (FA) 14:0, FA 15:0, FA 18:0, FA 18:3n3, as well as Cer(d18:1/16:0), compared to NAFL patients and healthy controls. No significant difference was found between NAFL patients and healthy controls. In conclusion, patients with NASH exhibited a distinctive plasma lipid profile that can differentiate them from NAFL patients and non-NAFLD populations. More data from larger cohorts are needed to validate these findings and examine possible implications for diagnostic and management strategies of the disease.

The Benefit of Probiotics in Pediatric Nonalcoholic Fatty Liver Disease: A Meta-analysis of Randomized Control Trials.

OBJECTIVES: We conducted a systematic review and meta-analysis to provide a summary of the current literature about the efficacy of probiotics in pediatric nonalcoholic fatty liver disease (NAFLD). METHODS: A systematic literature search through major electronic databases was carried out for RCTs till September 9, 2021, investigating the efficacy of probiotics in the treatment of pediatric patients with NAFLD. Weighted mean differences (WMD) and Standard Deviations (SD) were used to calculate continuous outcomes and a Risk Ratio with 95% CI was used for dichotomous outcomes. RESULTS: In total, 4 RCTs with 238 pediatric patients with NAFLD were included in the study. Probiotic supplementation revealed a statistically significant difference in transaminases' levels (ALT: WMD = -7.51 IU/L, 95% CI, -11.28 to -3.73, I 2 = 0%, P < 0.0001; AST: WMD = -6.46 IU/L, 95% CI, -9.31 to -3.61, I 2 = 0%, P < 0.00001), anthropometric characteristics, total cholesterol, triglycerides and ultrasonographic steatosis improvement. CONCLUSIONS: According to the data of this meta-analysis, probiotic supplementation, and especially supplementation of Lactobacillus acidophilus in combination with other strains of Bifidobacterium or Lactobacillus may be beneficial in the improvement of transaminases', lipid parameters' levels, ultrasonographic, and anthropometric characteristics in children with NAFLD. Current evidence does not allow specifying the exact beneficial strain of probiotics mentioned above. The possible effect of probiotics on liver histology improvement in pediatric NAFLD should be examined in future studies.

A Practical Approach to Identifying Pediatric Disease-Associated Undernutrition: A Position Statement from the ESPGHAN Special Interest Group on Clinical Malnutrition.

ABSTRACT: Disease-associated undernutrition (DAU) is still common in hospitalized children and is generally accepted to be associated with adverse effects on disease outcomes; hence making proper identification and assessment essential in the management of the sick child. There are however several barriers to routine screening, assessment, and treatment of sick children with poor nutritional status or DAU, including limited resources, lack of nutritional awareness, and lack of agreed nutrition policies. We recommend all pediatric facilities to 1) implement procedures for identification of children with (risk of) DAU, including nutritional screening, criteria for further assessment to establish diagnosis of DAU, and follow-up, 2) assess weight and height in all children asa minimum, and 3) have the opportunity for children at risk to be assessed by a hospital dietitian. An updated descriptive definition of pediatric DAU is proposed as "Undernutrition is a condition resulting from imbalanced nutrition or abnormal utilization of nutrients which causes clinically meaningful adverse effects on tissue function and/or body size/composition with subsequent impact on health outcomes." To facilitate comparison of undernutrition data, it is advised that in addition to commonly used criteria for undernutrition such as z score < -2 for weight-for-age, weight-for-length, or body mass index <-2, an unintentional decline of >1inthese z scores over time should be considered as an indicator requiring further assessment to establish DAU diagnosis. Since the etiology of DAU is multifactorial, clinical evaluation and anthropometry should ideally be complemented by measurements of body composition, assessment of nutritional intake, requirements, and losses, and considering disease specific factors.

Systematic review with meta-analysis: The effect of vitamin E supplementation in adult patients with non-alcoholic fatty liver disease.

BACKGROUND AND AIM: Νon-alcoholic fatty liver disease (NAFLD) is estimated to be the most common cause of end-stage liver disease in the next years. Vitamin E has shown beneficial effects as a possible "scavenger" of oxidative stress products, which play a major role in pathogenesis of the disease. The purpose of the present meta-analysis is to investigate the effects of vitamin E supplementation in biochemical and histological parameters in adult patients with NAFLD. METHODS: Literature search was performed in major electronic databases (MEDLINE, CENTRAL, and Embase) up to June 2020 for randomized clinical trials, which examined vitamin E versus placebo treatment in adults with NAFLD. Changes in liver enzymes were considered as primary outcomes while changes in histological, biochemical, and metabolic parameters as secondary. Quality of evidence was assessed through risk of bias according to the Cochrane risk of bias tool. RESULTS: Eight studies were included in qualitative analysis and seven in quantitative analysis. Vitamin E reduced the values of liver enzymes compared with placebo (-7.37 IU/L, 95% confidence interval: -10.11 to -4.64 for alanine aminotransferase, and -5.71 IU/L, 95% confidence interval: -9.49 to -1.93 for aspartate aminotransferase). Additionally, vitamin E improved statistically significantly liver pathology in every individual histological parameter as well as low-density lipoprotein cholesterol, fasting blood glucose, and serum leptin values. CONCLUSIONS: Vitamin E can improve biochemical and histological characteristics of NAFLD patients, especially of non-alcoholic steatohepatitis patients. The results indicate that vitamin E could be a promising choice and be considered as a treatment option in patients with NAFLD.

Dietary patterns and cardiovascular disease in Greek adults: The Hellenic National Nutrition and Health Survey (HNNHS).

BACKGROUND AND AIMS: Empirically-derived dietary patterns have been shown to have both positive and adverse associations with cardiovascular disease (CVD). Yet, such associations remain unclear in the Greek population. The aim of this study was to investigate the association between empirically-derived dietary patterns and the presence of CVD and CVD-related medical conditions in a nationally representative sample of Greek adults. METHODS AND RESULTS: Adult participants (≥20 years old) of the Hellenic National Nutrition and Health Survey (HNNHS) were included (N = 3552; 41.2% men; 43.7 years, SD: 18.1). Dietary patterns were derived by principal component analysis using 24-h recall data. The presence of dyslipidemia (elevated cholesterol and/or triglycerides), hypertension, coronary heart disease, and total CVD, was defined according to the International Clinical Diagnosis (ICD)-10 codes. Odds ratios of CVD outcomes were estimated across dietary patterns using multivariable logistic regression analysis. Three dietary patterns -Traditional (proxy Mediterranean), Western, and Prudent-were identified explaining 16.5% of the total variance in consumption. Logistic regression analysis, adjusted for age, sex, total caloric intake, sociodemographic characteristics, and other CVD risk factors, showed an inverse association between the Traditional dietary pattern and CVD presence (OR: 0.53; 95% CI: 0.30-0.95), and a positive association between the Western pattern and dyslipidemia (1.52; 1.02-2.26). No association was found between the Prudent pattern and CVD outcomes. CONCLUSION: The variability of food intake combinations in the Greek population seem to be associated with the presence of CVD and CVD related conditions. Such findings are imperative for national monitoring and informed priority setting.

Micronutrient intakes and their food sources among Greek children and adolescents.

OBJECTIVE: To assess the usual dietary intake of twenty micronutrients and to identify their food sources in a representative sample of Greek children and adolescents. DESIGN: Cross-sectional data from the Hellenic National Nutrition and Health Survey (HNNHS). Vitamin and mineral intakes were estimated from two 24 h dietary recalls by sex and age groups. Estimates were calculated using the National Research Council method and the statistical software package Stata13 to account for within- and between-person variations. The prevalence of nutrients' inadequacy among sample was estimated using the estimated average requirement (EAR) cut-point method. The contribution of food groups to nutrient intake was estimated to identify micronutrients food sources. SETTING: Greece. PARTICIPANTS: Children and adolescents aged 1-19 years (n 577) who provided sufficient and plausible 24-h recalls. RESULTS: A substantial percentage of children and adolescents had insufficient intakes of numerous micronutrients. Usual intake of vitamins D, K and potassium was inadequate in practically all individuals. Vitamin A, folate, Ca and Mg were also insufficient to a considerable percentage, especially in girls aged 14-18 years. Pantothenic acid was highlighted as nutrient of interest since only one out of ten boys 9-13 years and girls 14-19 years had intake above the EAR. Data demonstrated that food groups highly ranked in energy contribution were not necessarily important sources of micronutrients. CONCLUSIONS: Results suggest that micronutrient density of Greek children and adolescents' diet should be improved. These findings might be used by public health policy-makers to help young people optimise their food choices in Greece.

Exercise during pregnancy: a comparative review of guidelines.

Exercise during pregnancy may be beneficial provided that there are no contraindications. The aim of this study was to summarize and compare recommendations regarding exercise in pregnancy. Thus, a comparative descriptive review was conducted and included guidelines by the American College of Obstetricians and Gynecologists, the Society of Obstetricians and Gynaecologists of Canada and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. All compared guidelines recommend that pregnant women without contraindications should undertake physical activities regularly, however, the type of workout performed should be adjusted based on the previous exercise experience and the physical condition of each pregnant woman. A variation among the reviewed guidelines was identified on appropriate and inappropriate activities and on indications to interrupt exercise. To summarize, the adoption of an international up-to-date consensus regarding appropriate exercise during pregnancy may be beneficial in ensuring the safety of the pregnant women while promoting their physical and mental health.

Does coenzyme Q10 supplementation improve fertility outcomes in women undergoing assisted reproductive technology procedures? A systematic review and meta-analysis of randomized-controlled trials.

OBJECTIVE: Increased oxidative stress has been identified as a pathogenetic mechanism in female infertility. However, the effect of specific antioxidants, such as coenzyme Q10 (CoQ10), on the outcomes after assisted reproductive technologies (ART) has not been clarified. The aim of this study was to systematically review and meta-analyze the best available evidence regarding the effect of CoQ10 supplementation on clinical pregnancy (CPR), live birth (LBR), and miscarriage rates (MR) compared with placebo or no-treatment in women with infertility undergoing ART. METHODS: A comprehensive literature search was conducted in PubMed (MEDLINE), Cochrane, and Scopus, from inception to March 2020. Data were expressed as odds ratio (OR) with 95% confidence intervals (CI). The I2 index was employed for heterogeneity. RESULTS: Five randomized-controlled trials fulfilled eligibility criteria (449 infertile women; 215 in CoQ10 group and 234 in placebo/no treatment group). Oral supplementation of CoQ10 resulted in an increase of CPR when compared with placebo or no-treatment (28.8% vs. 14.1%, respectively; OR 2.44, 95% CI 1.30-4.59, p = 0.006; I2 32%). This effect remained significant when women with poor ovarian response and polycystic ovarian syndrome were analyzed separately. No difference between groups was observed regarding LBR (OR 1.67, 95% CI 0.66-4.25, p = 0.28; I2 34%) and MR (OR 0.61, 95% CI 0.13-2.81, p = 0.52; I2 0%). CONCLUSIONS: Oral supplementation of CoQ10 may increase CPR when compared with placebo or no-treatment, in women with infertility undergoing ART procedures, without an effect on LBR or MR.

Effects of Nutrition on Maternal Health, Fetal Development, and Perinatal Outcomes.

The early life theory states that the first 1000 days of a person's life are highly influential, as lasting health impacts can be attained during this period [...].

Impact of organic foods on chronic diseases and health perception: a systematic review of the evidence.

The aim of the present systematic review was to evaluate the existing data on the health impacts, of the consumption of organically grown foods versus conventionally farmed alternatives, with specific focus on the postulated health superiority of organic foods. A systematic literature research was performed in PubMed, Embase, Web of Science, and Google Scholar. Inclusion criteria were articles on adults (>18 years of age) consuming organic foods for ≥6 months, written in English language, and provision of comparative results between conventional and organic nutrition regarding health indices. From 1760 identified references, 21 primary research articles (2006-2022) met the inclusion criteria. Outcomes related to chronic disease prevalence, biomarker effects, and exposure to pesticides and other harmful substances were evaluated. A significant inverse relationship between organic food consumption and cardiometabolic risk factors, including obesity, diabetes mellitus, hypertension, and hyperlipidemia, was observed in the majority of prospective studies. The data on cancer risk and nutrient value comparison between organic and conventional foods were inconclusive. Clinical trials consistently indicated lower pesticide exposure in participants on organic diets, suggesting potential health benefits. The consumption of organic foods is associated with reduced cardiometabolic risks and pesticide exposure. However, the long-term impact on cancer risk remains undetermined. Future long-term studies are needed to establish whether an organic diet is superior to a conventional one in terms of overall health benefits.

The Association between Food Groups, Nutraceuticals, and Food Supplements Consumption on Vascular Health Outcomes: A Literature Review.

Vascular aging, marked by alterations in the structure and function of blood vessels, including heightened arterial stiffness and impaired endothelial function, is linked to a higher likelihood of developing cardiovascular and age-associated pathological conditions. Oxidative stress and inflammation are key stimulation factors in vascular aging. Engaging in healthy dietary habits could enhance the functioning of blood vessels. The aim of this study was to conduct a literature review of the evidence regarding the relationship between food regimens, nutraceuticals, and dietary supplements and vascular health. A search of electronic databases, including PubMed, Scopus, and Web of Science Core Collection, was performed. Experimental and observational studies evaluating the association between food groups, nutraceuticals, supplements, and endothelial function and/or arterial stiffness were deemed eligible for this narrative review. Based on the current body of the included studies, food groups, nutraceuticals, and dietary supplements may not demonstrate superiority over placebos in enhancing markers of vascular health. To obtain more reliable evidence on the effectiveness of interventions in vascular health, additional RCTs with larger sample sizes, extended follow-up periods, and multi-center participation are necessary. Enhancing the credibility of these RCTs requires better control of dietary variables and more precise measurement of vascular health markers.

The Effect of Diet on Vascular Aging: A Narrative Review of the Available Literature.

Early vascular aging is related to various cardiovascular diseases including hypertension, coronary heart disease, and stroke. Healthful lifestyle practices and interventions, including dietary regimens and consistent aerobic exercise, exert favorable modulation on these processes, thereby diminishing the risk of cardiovascular disease with advancing age. The principal objective of this review was to conduct a comprehensive evaluation and synthesis of the available literature regarding the effectiveness of different diets on vascular health, such as arterial stiffness and endothelial function. To conduct this review, a thorough search of electronic databases including PubMed, Scopus, and Web of Science Core Collection was carried out. Based on the existing evidence, the Mediterranean, Dietary Approaches to Stop Hypertension, and low-calorie diets may have a beneficial effect on vascular health. However, more randomized controlled trials with sufficient sample sizes, longer follow-ups, rigorous methodologies, and, possibly, head-to-head comparisons between the different diets are needed to shed light on this topic.

Impact of Maternal Micronutrient Intake on Gestational Diabetes Risk: Results from Greece's BORN2020 Prospective Cohort Study.

Understanding how maternal micronutrient intake and dietary habits impact gestational diabetes mellitus (GDM) is crucial. Data from 797 pregnant women were prospectively analyzed to assess GDM status with the oral glucose tolerance test (OGTT). Nutritional intake was evaluated using a validated food frequency questionnaire (FFQ) across two periods: Period A, covering 6 months before pregnancy, and Period B, from pregnancy onset to mid-gestation (24 weeks). Micronutrient intakes were compared against the European Food Safety Authority (EFSA) dietary reference values (DRVs) and were used to estimate the mean adequacy ratio (MAR) to assess dietary adequacy. GDM was diagnosed in 14.7% (n = 117) of women with the characteristics of a higher mean maternal age (MA) and pre-pregnancy body mass index (BMI). Out of the 13 vitamins assessed, biotin, folate, niacin, and pantothenic acid were found significantly higher in the GDM group, as did iron, magnesium, manganese, phosphorus, and zinc from the 10 minerals. The results were influenced by the timing of the assessment. Importantly, MAR was higher during pregnancy and was found to increase the risk of GDM by 1% (95%CI: 1, 1.02). A sensitivity analysis revealed that reducing MAR significantly raised the GDM risk by 68% (95%CI: 1.02, 2.79). No association was revealed between adherence to the Mediterranean diet (MD) and GDM risk. These findings highlight areas for further investigation into whether dietary modifications involving these specific micronutrients could effectively influence GDM outcomes.

The Relation between Consumer Perception and Objective Understanding of Front-of-Package Nutrition Labels (FOPNLs); Results from an Online Representative Survey.

BACKGROUND: This study investigates the efficacy of Front-of-Pack Nutrition Labels (FOPNLs) as a cost-effective tool for improving dietary choices among Greek consumers. The purpose of the study was to investigate Greek customers' preferences and comprehension of commonly used European FOPNL schemes. METHODS: The Hellenic Food Authority and the Agricultural University of Athens performed a representative online survey in March 2022, titled "The Role of Nutritional Labelling in Public Perception and Food Procurement." Consumers responded to a questionnaire separated into two parts. Part one included (i) personal, sociodemographic information, and (ii) subjective opinions on the FOPNL schemes, and part two comprised (iii) an objective understanding of NutriScore and NutrInform Battery, using 15 different foods. Participants were randomly allocated to these groups, and general mixed models were used for analysis. RESULTS: A total of 1389 adults completed the first part of the survey, and 74.8% completed the second part. The Multiple Traffic Lights scheme was the preferred FOPNL, chosen by 48.4% of respondents, compared to 19.7% for NutrInform Battery and 12.3% for NutriScore. However, the mean objective assessment score was highest for NutriScore (5.8 ± 2.3) compared to NutrInform Battery (5.4 ± 1.9). CONCLUSION: The results highlight the necessity for comprehensive nutrition education programs by showing a considerable gap between subjective preferences and an objective understanding of nutrition labels.

Antidepressants compared to placebo for people with binge eating disorder: A systematic review and meta-analysis.

Binge eating disorder (BED) is the most prevalent eating disorder. Treatment options include pharmacotherapy as well as psychotherapy, with the latter recommended as a first-line option. However, the use of psychotherapeutic interventions poses several challenges. Antidepressants are easily accessible, but they lack robust evidence-base. This systematic review aims to comprehensively examine the efficacy and safety of antidepressants for the treatment of BED. Five databases were searched for randomized controlled trials (RCTs) comparing antidepressants vs. placebo in BED until 23/11/2023. Pairwise meta-analytic evaluations were performed. The primary outcomes were remission and binge eating frequency. Secondary outcomes were response to treatment, eating psychopathology, depression, anxiety, body weight, Body Mass Index (BMI), all-cause discontinuation, discontinuation due to adverse effects and total adverse events. Sixteen RCTs with a total of 984 participants were meta-analysed. Antidepressants were more effective than placebo in achieving remission (RR: 1.39, 95 % CI: 1.04 to 1.86) and in reducing binge eating episodes (SMD: -0.29, 95 % CI: -0.51 to -0.06). Similarly, in the secondary outcomes of response and depression, antidepressants demonstrated superiority over placebo. Antidepressants appear to be effective in reducing symptoms of BED. Small samples and effect sizes hinder the generalizability and clinical utility of these results. There is a lack of follow-up findings regarding the maintenance of effects. There is a pressing need for more RCTs examining antidepressants and other types of pharmacotherapy. Future research should include larger number of participants and increase the duration of follow-up.

Effect of Crocus sativus Extract Supplementation in the Metabolic Control of People with Diabetes Mellitus Type 1: A Double-Blind Randomized Placebo-Controlled Trial.

Introduction-Background: Data from experimental trials show that Crocus sativus L. (saffron) is considered to improve glycemia, lipid profile, and blood pressure and reduce oxidative stress. So far, clinical trials have been conducted in individuals with metabolic syndrome and Diabetes Mellitus type 2 (DMT-2). The purpose of this study is to assess the effectiveness of saffron in individuals with Diabetes Mellitus type 1 (DMT-1). PATIENTS-METHODS: 61 individuals with DMT-1, mean age 48 years old (48.3 ± 14.6), 26 females (42.6%) were randomized to receive a new oral supplement in sachets containing probiotics, prebiotics, magnesium, and Crocus sativus L. extract or placebo containing probiotics, prebiotics and magnesium daily for 6 months. Glycemic control was assessed with a continuous glucose monitoring system and laboratory measurement of HbA1c and lipid profile was also examined. Blood pressure at baseline and end of intervention was also measured. Individuals were either on a continuous subcutaneous insulin infusion with an insulin pump or in multiple daily injection regimens. Diabetes distress and satiety were assessed through a questionnaire and body composition was assessed with bioelectrical impedance. RESULTS: At the end of the intervention, the two groups differed significantly only in serum triglycerides (p = 0.049). After 6 months of treatment, a significant reduction in the active group was observed in glycated hemoglobin (p = 0.046) and serum triglycerides (p = 0.021) compared to baseline. The other primary endpoints (glycemic control, lipid profile, blood pressure) did not differ within the groups from baseline to end of intervention, and there was no significant difference between the two groups. Diabetes distress score improved significantly only in the active group (p = 0.044), suggesting an overall improvement in diabetes disease burden in these individuals but that was not significant enough between the two groups. CONCLUSIONS: A probiotic supplement with saffron extract improves serum triglycerides in well-controlled people with DMT-1 and may potentially be a valuable adjunct for enhancing glycemic control.