Discussion
obesity, NAFLD, Hyperglycemia, non-communicable chronic diseases, weight gain, overweight, abdominal obesity metabolic syndrome, hyperinsulinemia, weight loss, dyslipidemia
OBESITY, HYPERGLYCEMIA, OBESE, CARDIOVASCULAR DISEASES, DISEASE, LIVER DAMAGE, CHRONIC DISEASES, ADVERSE EFFECTS, ABDOMINAL OBESITY METABOLIC SYNDROME, HYPERINSULINEMIA, OXIDATIVE STRESS, DYSLIPIDEMIA
The application of natural products or their derivatives for the prevention or treatment of several pathologies represents a reasonable and accessible way for clinical practitioners and the general population to use natural resources as viable alternative therapies for health promotion and disease intervention. The development of new products containing different molecules and natural derivatives that interact synergistically has shown beneficial potential, acting holistically and producing few adverse effects on the human body (Based on these preclinical studies and aiming to build up the evidence pyramid in this rapidly growing area of research, we have initiated a double-blind randomized clinical trial applying this supplement formula to participants who were overweight or obese. In this clinical trial, we began by focusing on evaluating clinical, biochemical, and anthropometric parameters. This is relevant because it brings scientific criteria for the investigation and analysis of parameters affordable to clinical practitioners who work in the area of obesity prevention and treatment. In this way, we hope to generate knowledge and scientific support for the advancement and updating of clinical practice in this research area.Regarding the results of our randomized double-blind clinical trial, it is important to note that there was no indication of dietary interventions, encouragement of physical activity, or sort of a change in the participants’ lifestyle. Therefore, our results reflect the effects that can be directly and exclusively attributed to the consumption of the nutraceutical formula applied in the study.The characterization of the anthropometric and demographic data shows that there are no significant differences between the groups at the beginning of the study. This is relevant to state the similarity of both groups in our sample to guarantee the reliability of data. Analyzing the anthropometrics among the supplementation groups at different time points, it is noteworthy that the WC reduction in both groups was promoted by the supplementation throughout the time. Despite the lack of weight loss, the reduction of WC represents a marker of decreased cardiovascular risk for the participants. It is well established that high WC reflects abdominal fat deposition, and it is strongly associated with the development of non-communicable chronic diseases (In our data, the supplements with a combination of minerals, fibers, and bioactive compounds were able to restore low cardiovascular risk levels without the need for medicines or dietary interventions. It might be related to high metabolic rates and an increase in energy expenditure promoted by the supplement compounds that are described to enhance molecules related to fatty acid metabolism activation (Considering the biochemical parameters analyzed in serum samples collected at the end of the experimental protocol, there were no significant changes in serum concentrations of total cholesterol and its fractions or TGs. The improvement of the serum lipoprotein profile through the consumption of nutraceutical compounds such as fibers and antioxidants is recognized in the literature as a strategy to control dyslipidemia and prevent the onset of cardiovascular diseases, among other metabolic changes (To investigate other markers related to NAFLD, serum concentrations of AST and ALT as well as the AAR were evaluated. AST, ALT, and gamma-GT are accessible clinical markers to check for liver damage. It is known that ALT is found mainly in the hepatocyte cytoplasm, while AST is present in the mitochondria. Therefore, in cases of mild liver damage, ALT is altered in the serum, while in severe liver damage, there is an increase in AST in the bloodstream (In obesity, the classic chronic low-grade inflammatory state, also known as metainflammation, is associated with increased inflammatory processes; the reactive oxygen species (ROS) is also increased. We did not find alterations in the C-reactive protein; however, this can be considered a nonspecific inflammatory marker and therefore not very sensitive to the discreet changes promoted by the metainflammation of obesity. Hyperglycemia and hyperinsulinemia are also known to trigger an inflammatory process and oxidative stress environment (Accessing the endocrine profile, we found a significant reduction in cortisol levels promoted by the new supplement tested. Cortisol is a hormone well known for its key role in responding to stressful stimuli. Despite its physiological role, in obesity, it is known that high levels of cortisol promote body weight gain and increase appetite with a preference for energy-dense food, contributing to a high cardiometabolic risk. Also, chronic exposure to glucocorticoids such as cortisol is known to promote the specifically abdominal obesity metabolic syndrome and eventually cardiovascular diseases. In addition, the reduction in cortisol is related to the improvement in sleep quality, which is also directly linked to the prevalence of obesity (In this way, our primary clinical data allow us to conclude that the new supplement has an innovative combination of nutrients and bioactive compounds capable of promoting the improvement of biochemical and endocrine parameters in overweight/obesity. Its effect was pronounced, since it was able to promote metabolic improvement without the association of lifestyle change therapies such as diet intervention and physical activity. Although the nutrients of this supplement are accessible through a healthy diet, epidemiological data show that the consumption of these nutrients is usually deficient in a large part of the population. Thus, supplementation proves to be an important alternative to maintain adequate intake levels when the diet does not meet this demand. Therefore, the supplementation of beneficial compounds can be a valuable tool for preventing the onset of chronic diseases in the long term, avoiding the need for medication treatments. Nevertheless, these data represent an initial study of this new supplement. For more robust conclusions to be obtained, further studies are necessary with a larger sample size of both genders equally distributed. Further research also needs to address refined and in-depth biomolecular analyses that would provide a basis for a discussion on the reported clinical findings of robust cellular pathways, which might be considered another limitation of the present study. Nonetheless, the present results allow us to suggest that the parameters analyzed in this study can also be evaluated in clinical practice as an indication of endocrine and metabolic changes, bringing the research for the development of new nutraceuticals closer to the clinical practice of medical professionals, which has proven to be a major barrier between scientific research and practice application.