SUPPORTIVE TREATMENT OF VASCULAR DYSFUNCTION IN PEDIATRIC SUBJECTS WITH OBESITY: THE OBELIX STUDY

INTRODUCTION: Overweight and obese children develop abnormal endothelial cell dysfunction with increased vasomotor tone and inflammation. Curcumin, resveratrol, zinc, magnesium, selenium, soy, folic acid, and Vitamin D have shown potential beneficial effects on endothelial function. We test, among overweight and obese pediatric subjects, the effects on the endothelium of a combination of curcumin, resveratrol, zinc, magnesium, soy, folic acid, selenium, and Vitamin D. METHODS: 48 subjects (6-17 years) were randomized into two groups (placebo Vs treatment) and attended three visits at 0, 3, and 6 months (+/- 15 days). Endothelial function was assessed through the Laser Doppler Flowmetry technique using “post occlusive release hyperemic test” (PORH) for estimation of Delta Flow (DF) and Hyperemic Area under Curve index (Hyperemic AUC index) and “heat provocation test” (HPT) to measure Delta Flow HPT” (DFHPT). RESULTS: DF, Hyperemic AUC index and DFHPT represent recognized parameters for estimating endothelial dysfunction in both pediatric and adult age. Significant DF difference was noted at time-6-month in both groups (p<0.001). Overall time trend was significantly different between baseline, time-3-months, and 6-months both in Placebo (p<0.05) and Treatment (p< 0.001) groups and their comparison (p < 0.001). No differences were noted in Hyperemic AUC index (3 and 6 months), while there were significant differences in time trends of Treatment (p< 0.001) and Placebo (p<0.05) groups and their comparison (p < 0.001). DFHPT difference between groups was significant at 3 months and 6 months (p<0.05). The overall time trend was significant exclusively in "Treatment group" between time-3-month and 6-months (p<0.05). Correlation with anthropometrics was found for DF and BMI (r=0.677 at 6 months; p<0.05), as well as for Hyperemic AUC index and males (r= 0.348, p<0.05), while DFHPT showed no correlation. CONCLUSIONS: Curcumin, resveratrol, zinc, magnesium, soy, folic acid, selenium, and Vitamin D appear to be promising in enhancing endothelial function by improvement of both DF in post-occlusive release hyperemia test and DF in the heat provocation test, potentially lowering the risk of developing cardiovascular diseases in overweight and obese pediatric subjects.