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Purpose: It is known that obesity has a multifactorial etiology that involves genetic and environmental factors. The WHO estimates the worldwide prevalence of 1.9 billion overweight adults and more than 650 million people with obesity. These alarming data highlight the high and growing prevalence of obesity and represent a risk factor for the development and aggravation of other chronic diseases, such as nonalcoholic fatty liver disease (NAFLD) that is frequently considered the hepatic outcome of type 2 diabetes. The use of non-pharmacological therapies such as food supplements, nutraceuticals, and natural integrative therapies has grown as an alternative tool for obesity-related diseases compared to conventional medications. However, it is a still little explored research field and lacks scientific evidence of therapeutic effectiveness. Considering this, the aim is to evaluate whether a new nutraceutical supplement composition can improve and supply essential mineral nutrients, providing an improvement of obesity-related metabolic and endocrine parameters., Methods: Sedentary volunteers (women and men) with body mass index (BMI) ≤34.9 kg/m 2 were divided into two groups: Novel Nutraceutical Supplement_(S) (n = 30) and Novel Nutraceutical Supplement (n = 29), differing in the absence (S) or presence of silymarin, respectively. Volunteers were instructed to take two capsules in the morning and two capsules in the evening. No nutritional intervention was performed during the study period. The data (anthropometrics and anamneses) and harvest blood (biochemistry and hormonal exams) were collected at three different time points: baseline time [day 0 (T0)], day 90 (T90), and day 180 (T180) post-supplementation., Results: In the anthropometric analysis, the waist circumference in middle abdomen (WC-mid) and waist circumference in iliac crest (WC-IC) were reduced. Also, the waist-to-height ratio (WHt R) and waist-to-hip ratio (WHR) seem to slightly decrease alongside the supplementation period with both nutraceutical supplements tested as well as transaminase enzyme ratio [aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio (AAR)], a known as a biomarker of NAFLD, and endocrine hormones cortisol and thyroid-stimulating hormone (TSH) at 90 and 180 days post-supplementation., Conclusions: In a condition associated with sedentary and no nutritional intervention, the new nutraceutical supplement composition demonstrated the ability to be a strong and newfangled tool to improve important biomarkers associated with obesity and its comorbidities., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Nehmi-Filho, Santamarina, de Freitas, Trarbach, de Oliveira, Palace-Berl, de Souza, de Miranda, Escamilla-Garcia, Otoch and Pessoa.)

Overweight and obesity are closely linked to gut dysbiosis/dysmetabolism and disrupted De‐Ritis ratio [aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio], which may contribute to chronic noncommunicable diseases onset. Concurrently, extensive research explores nutraceuticals, and health‐enhancing supplements, for disease prevention or treatment. Thus, sedentary overweight volunteers were double‐blind randomized into two groups: Novel Nutraceutical_(S) (without silymarin) and Novel Nutraceutical (with silymarin). Experimental formulations were orally administered twice daily over 180 consecutive days. We evaluated fecal gut microbiota, based on partial 16S rRNA sequences, biochemistry and endocrine markers, steatosis biomarker (AST/ALT ratio), and anthropometric parameters. Post‐supplementation, only the Novel Nutraceutical group reduced Clostridium clostridioforme (Firmicutes), Firmicutes/Bacteroidetes ratio (F/B ratio), and De‐Ritis ratio, while elevating Bacteroides caccae and Bacteroides uniformis (Bacteroidetes) in Brazilian sedentary overweight volunteers after 180 days. In summary, the results presented here allow us to suggest the gut microbiota as the action mechanism of the Novel Nutraceutical promoting metabolic hepatic recovery in obesity/overweight non‐drug interventions. [ABSTRACT FROM AUTHOR]

Purpose: It is known that obesity has a multifactorial etiology that involves genetic and environmental factors. The WHO estimates the worldwide prevalence of 1.9 billion overweight adults and more than 650 million people with obesity. These alarming data highlight the high and growing prevalence of obesity and represent a risk factor for the development and aggravation of other chronic diseases, such as nonalcoholic fatty liver disease (NAFLD) that is frequently considered the hepatic outcome of type 2 diabetes. The use of non-pharmacological therapies such as food supplements, nutraceuticals, and natural integrative therapies has grown as an alternative tool for obesity-related diseases compared to conventional medications. However, it is a still little explored research field and lacks scientific evidence of therapeutic effectiveness. Considering this, the aim is to evaluate whether a new nutraceutical supplement composition can improve and supply essential mineral nutrients, providing an improvement of obesity-related metabolic and endocrine parameters. Methods: Sedentary volunteers (women and men) with body mass index (BMI) =34.9 kg/m² were divided into two groups: Novel Nutraceutical Supplement_(S) (n = 30) and Novel Nutraceutical Supplement (n = 29), differing in the absence (S) or presence of silymarin, respectively. Volunteers were instructed to take two capsules in the morning and two capsules in the evening. No nutritional intervention was performed during the study period. The data (anthropometrics and anamneses) and harvest blood (biochemistry and hormonal exams) were collected at three different time points: baseline time [day 0 (T0)], day 90 (T90), and day 180 (T180) post-supplementation. Results: In the anthropometric analysis, the waist circumference in middle abdomen (WC-mid) and waist circumference in iliac crest (WC-IC) were reduced. Also, the waist-to-height ratio (WHt R) and waist-to-hip ratio (WHR) seem to slightly decrease alongside the supplementation period with both nutraceutical supplements tested as well as transaminase enzyme ratio [aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio (AAR)], a known as a biomarker of NAFLD, and endocrine hormones cortisol and thyroidstimulating hormone (TSH) at 90 and 180 days post-supplementation. Conclusions: In a condition associated with sedentary and no nutritional intervention, the new nutraceutical supplement composition demonstrated the ability to be a strong and newfangled tool to improve important biomarkers associated with obesity and its comorbidities. [ABSTRACT FROM AUTHOR]

[Display omitted] • The Novel Nutraceutical supplement recovers gut epithelium morpho-histology. • The supplementation increases gut microbiota diversity in high-fat-diet dysbiosis. • Firmicutes/Bacteroidetes ratio increased by the Novel Nutraceutical supplement. • The supplementation restores gut epithelium without Akkermansia genus interaction. Gut dysbiosis contributes to chronic inflammation and oxidative stress associated with metabolic syndrome, and non-pharmacological, health-promoting supplements like nutraceuticals have been studied and used as a way to prevent or treat several illnesses. Thus, male C57BL/6 mice were divided into the following groups: control (CTL)_Vehicle and CTL_Nutraceutical; high-fat diet (HFD)_Vehicle, HFD_Nutraceutical, HFD_Nutraceutical_S, and isolated compounds. The vehicle and experimental formulations were administered by gavage once a day for four weeks with a high-fat diet simultaneously. In addition, we evaluated the composition of the fecal microbiota by partial 16S rRNA sequences directly amplified using a bacterial/archaeal primer set 515F/806R, and large intestine histomorphology was examined by H&E (Hematoxylin and Eosin), Masson's trichrome (MT), and PAS-AB (Periodic Acid Schiff-Alcian Blue) stains in these groups of mice. After four weeks of supplementation, only the Novel Nutraceutical supplement was able to increase α and β-diversities, modulate the relative abundance in gut microbiota, decrease Firmicutes, and increase Bacteroidetes bacteria, meanwhile recovering the large intestine's (colon) histomorphology in CTL and HFD groups. [ABSTRACT FROM AUTHOR]