Background: Type 2 diabetes mellitus (T2DM) is commonly associated with hyperglycemia, dyslipidemia, oxidative stress and inflammation which are well known cardiovascular risk factors. Pomegranate peel polyphenols have a proven hypolipemic, antioxidant and anti-inflammatory activity. However, there is a lack of clinical studies that would confirm its antioxidant and anti-inflammatory effects in diabetic patients. The potential of pomegranate peel extract (PoPEx) to counteract inflammation and oxidative stress in T2DM patients was investigated. For this purpose, a randomized, double-blind placebo-controlled study involving adult T2DM patients treated with PoPEx or placebo for eight-weeks was conducted. Methods: Patients were randomly divided into two groups: the first group (n = 30) received capsules containing PoPEx 250 mg twice daily, while the placebo group (n = 30) received placebo capsules twice daily. Plasma concentration of inflammatory factors (interleukin 6 (IL-6), tumor necrosis factor α (TNF-α) and high sensitivity C reactive protein (hsCRP)), oxidative stress biomarkers (thiobarbituric acid reactive substances (TBARS), nitrites (NO2-), superoxide anion radical (O2-), hydrogen peroxide (H2O2), total antioxidant capacity (TAC)), homocysteine and lipid profile were analyzed. Results: The PoPEx treatment showed a significant reduction of inflammatory factors (IL-6, TNF-α, hsCRP), oxidative stress biomarkers (TBARS, NO2-, O2-) and homocysteine, while the TAC was increased. Moreover, a significant improvement in lipid profile was observed in the PoPEx group. Additional analysis showed a significant inverse correlation between the decrements of all measured inflammatory markers and TAC in the PoPEx group. Conclusions: The study demonstrated that eight-week-long PoPEx administration had favorable effects on inflammatory status and oxidative stress biomarkers in diabetic patients.

Psoriasis is an autoimmune and inflammatory skin disease. Psoriatic patients express higher levels of plasma homocysteine (Hcy) concentration and pro-inflammatory mediators than healthy people; this is frequently associated with vitamin D deficiency. The aim of this clinical study was to investigate the effects of high doses of vitamin D supplementation on the parameters of Hcy metabolism and cytokines in sera of psoriatic patients. This prospective study was conducted on 40 psoriatic patients who had the vitamin D deficiency. All patients received vitamin D 5000 IU/day for three months. Clinical and biochemical measurements were taken at baseline and at follow up (3 months). The results showed that the severity of clinical features, measured by the psoriasis area severity index (PASI) score, were considerably improved in patients after vitamin D supplementation. After vitamin D supplementation, most of the patients (n = 25 or 62.5%) had mild clinical form (p < 0.001). After twelve weeks of intervention period, there were significant increases in vitamin D and B₁₂ serum levels in comparison to the levels that had been measured at the beginning of the study (56.77 ± 14.66 nmol/L and 301.08 ± 95.02 pg/mL vs. 103.85 ± 32.20 nmol/L and 362.81 ± 118.56 pg/mL, respectively; p < 0.001). Moreover, serum levels of Hcy and folate were significantly lower at the end of the study in comparison with the initial levels (12.45 ± 1.92 µmol/L and 8.01 ± 3.88 mg/mL vs. 10.38 ± 1.66 µmol/L and 6.27 ± 2.60 mg/mL, respectively). High doses of vitamin D supplementation led to a significant decrease in pro-inflammatory cytokines (IFN-ɤ, TNF-α, IL-1β, IL-6, IL-8, and IL-17) and high-sensitivity C-reactive protein (hsCRP), whereas the production of anti-inflammatory cytokines (IL-10, IL-5) was up-regulated. In conclusion, supplementation with high doses of vitamin D could be one of the possible preventive and therapeutic measures to reduce systemic inflammation in psoriatic patients.

Background. Oxidative stress and inflammation are closely related pathophysiological processes, both occurring in type 2 diabetes mellitus (T2DM). In addition to the standard treatment of T2DM, a potential strategy has been focused on the use of bile acids (BAs) as an additional treatment. Ursodeoxycholic acid (UDCA), as the first BA used in humans, improves glucose and lipid metabolism and attenuates oxidative stress. The aim of this study was to evaluate the potential metabolic, anti‐inflammatory, and antioxidative effects of UDCA in patients with T2DM. Methods. This prospective, double‐blind, placebo‐controlled clinical study included 60 patients with T2DM, randomly allocated to receive UDCA or placebo. Subjects were treated with 500 mg tablets of UDCA or placebo administered three times per day (total dose of 1500 mg/day) for eight weeks. Two study visits, at the beginning (F0) and at the end (F1) of the study, included the interview, anthropometric and clinical measurements, and biochemical analyses. Results. UDCA treatment showed a significant reduction in body mass index (p = 0.024) and in diastolic blood pressure (p = 0.033), compared to placebo. In addition, there was a statistically significant difference in waist circumference in the UDCA group before and after treatment (p < 0.05). Although no statistical significance was observed at the two‐month follow‐up assessment, an average decrease in glucose levels in the UDCA group was observed. After two months of the intervention period, a significant decrease in the activity of liver enzymes was noticed. Furthermore, a significant reduction in prooxidative parameters (TBARS, NO₂^-, H₂O₂) and significant elevation in antioxidative parameters such as SOD and GSH were found (p < 0.001). Conclusions. The eight‐week UDCA administration showed beneficial effects on metabolic and oxidative stress parameters in patients with T2DM. Thus, UDCA could attenuate the progression and complications of diabetes and should be considered as an adjuvant to other diabetes treatment modalities. This trial is registered with NCT05416580.

Body composition in childhood is not only a marker of the prevalence of obesity, but it can also be used to assess associated metabolic complications. Bioelectrical impedance analysis (BIA) shows promise as an easy to use, rapid, and non-invasive tool to evaluate body composition. The objectives of this study were to: (a) develop BIA prediction equations to estimate total body water (TBW) and fat-free mass (FFM) in European children and early adolescents and to validate the analysis with the deuterium dilution as the reference technique and (b) compare our results with previously published paediatric BIA equations. The cohort included 266 healthy children and adolescents between 7 and 14 years of age, 46% girls, in five European countries: Bosnia and Herzegovina, Latvia, Montenegro, North Macedonia, and Portugal. TBW and FFM were the target variables in the developed regression models. For model development, the dataset was randomly split into training and test sets, in 70:30 ratio, respectively. Model tuning was performed with 10-fold cross-validation that confirmed the unbiased estimate of its performance. The final regression models were retrained on the whole dataset. Cross-validated regression models were developed using resistance index, weight, and sex as the optimal predictors. The new prediction equations explained 87% variability in both TBW and FFM. Limits of agreement between BIA and reference values, were within ±17% of the mean, (-3.4, 3.7) and (-4.5, 4.8) kg for TBW and FFM, respectively. BIA FFM and TBW estimates were within one standard deviation for approximately 83% of the children. BIA prediction equations underestimated TBW and FFM by 0.2 kg and 0.1 kg respectively with no proportional bias and comparable accuracy among different BMI-for-age subgroups. Comparison with predictive equations from published studies revealed varying discrepancy rates with the deuterium dilution measurements, with only two being equivalent to the equations developed in this study. The small difference between deuterium dilution and BIA measurements validated by Bland-Altman analysis, supports the application of BIA for epidemiological studies in European children using the developed equations.

Background/Aim: Polyphenol compounds obtained from pomegranate have beneficial pharmacological activities in the treatment of diabetes mellitus type 2 (DMT2). Most of DMT2 patients are overweight or obese and obesity by itself is very much related to insulin resistance and abnormalities in insulin secretion. This clinical study aimed to evaluate the pomegranate peel extract (PoPEx) activity on anthropometric parameters and body composition of overweight patients with DMT2. Methods: Sixty patients with DMT2 on continuous metformin therapy were involved in this double-blind, placebo-controlled, randomised clinical trial. Patients from the study group (n=30) were treated with capsules containing PoPEx (250 mg) twice a day for 8-week period, while those ones from the placebo group (n=30) received placebo capsules for the same period. Anthropometric characteristics (body weight, waist circumference, fat mass percentage, visceral fat level) were measured at the beginning and at the end of the study. Results: Eight-week treatment with PoPEx resulted in significant changes in BMI (mean value ± standard deviation: 0.18 ± 0.30 kg/m2 ) and body mass (0.48 ± 0.93 kg). The intake of PoPEx produced a significant decrease in waist circumference (z = -4.613, p < 0.001, r = 0.60) indicating a large effect size using Cohen's d-test, and a non-significant decrease in the level of visceral fat. The results showed a non-significant reduction in fat mass percentage in PoPEx group (-0.58 ± 2.21 %, p = 0.159) compared with the placebo group (0.14 ± 1.24 %, p = 0.546). Conclusion: The eight-week supplementation with PoPEx had a beneficial effect on anthropometry and body composition of overweight diabetic patients.