Novel nutraceutical supplements with yeast β-glucan, prebiotics, minerals, and Silybum marianum (silymarin) ameliorate obesity-related metabolic and clinical parameters: A double-blind randomized trial.

Autor:	Nehmi-Filho V; Natural Products and Derivatives Laboratory (LIM-26), Department of Surgery, University of São Paulo Medical School, São Paulo, SP, Brazil.; Research and Development Efeom Nutrition S/A, São Paulo, SP, Brazil., Santamarina AB; Department of Biosciences, Federal University of São Paulo (UNIFESP), Santos, SP, Brazil., de Freitas JA; Natural Products and Derivatives Laboratory (LIM-26), Department of Surgery, University of São Paulo Medical School, São Paulo, SP, Brazil.; Research and Development Efeom Nutrition S/A, São Paulo, SP, Brazil., Trarbach EB; Laboratory of Cellular and Molecular Endocrinology (LIM25), Division of Endocrinology and Metabology, Clinics Hospital, University of São Paulo Medical School, São Paulo, SP, Brazil., de Oliveira DR; Natural Products and Derivatives Laboratory (LIM-26), Department of Surgery, University of São Paulo Medical School, São Paulo, SP, Brazil.; Department of Pharmacology & Toxicology, Medical College of Wisconsin, Milwaukee, WI, United States., Palace-Berl F; Natural Products and Derivatives Laboratory (LIM-26), Department of Surgery, University of São Paulo Medical School, São Paulo, SP, Brazil., de Souza E; Monte Azul Ambulatory, São Paulo, SP, Brazil., de Miranda DA; Departament of Physiology, Escola Paulista de Medicina/Universidade Federal de São Paulo, São Paulo, SP, Brazil., Escamilla-Garcia A; University Hospital of the University of São Paulo, University of São Paulo Medical School, São Paulo, SP, Brazil., Otoch JP; Natural Products and Derivatives Laboratory (LIM-26), Department of Surgery, University of São Paulo Medical School, São Paulo, SP, Brazil.; Research and Development Efeom Nutrition S/A, São Paulo, SP, Brazil.; University Hospital of the University of São Paulo, University of São Paulo Medical School, São Paulo, SP, Brazil., Pessoa AFM; Natural Products and Derivatives Laboratory (LIM-26), Department of Surgery, University of São Paulo Medical School, São Paulo, SP, Brazil.; Research and Development Efeom Nutrition S/A, São Paulo, SP, Brazil.; Natural Products Committee, Brazilian Academic Consortium for Integrative Health (CABSIN), São Paulo, Brazil.
Jazyk:	angličtina
Zdroj:	Frontiers in endocrinology [Front Endocrinol (Lausanne)] 2023 Jan 27; Vol. 13, pp. 1089938. Date of Electronic Publication: 2023 Jan 27 (Print Publication: 2022).
DOI:	10.3389/fendo.2022.1089938
Abstrakt:	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.)
Databáze:	MEDLINE
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