Nutraceutical Composition Containing Natural Products Derivatives on the Modulation of the Endocrine Neuroimmune Axis
Condition: Insulin Resistance; Inflammatory Bowel Diseases; Overweight and Obesity; Healthy
MeSH terms: Inflammatory Bowel Diseases; Overweight; Insulin Resistance
Study type: Interventional

Summary: 
      The use of natural products in the prevention or treatment of chronic diseases is an emerging
      field in current medicine. And studying the mechanisms of actions by which natural products
      act in our bodies contributes to the rational use of these products. And the combination of
      different natural products such as prebiotics (FOS- fructooligosaccharides,
      GOS-Galactooligosaccharides and beta-glucans derived from yeast), herbal medicine (Silybum
      marianum), and minerals (Se-selenium, Zn-Zinc, and Mg-Magnesium), o which would result in a
      synergistic association between them can contribute to achieving not only preventive effects
      but treatment for chronic diseases such as diabetes and obesity. The present study aims to
      study the effects of a composition containing natural products on factors and markers that
      are part of mitochondrial biogenesis and the neuroimmune-endocrine system in healthy
      volunteers and that present grade 1 overweight/obesity.
    

Detailed description: 
      Obesity and diabetes are chronic diseases characterized by increased visceral adipose tissue
      and sub-acute inflammation. These conditions can lead to insulin resistance, hyperglycemia,
      oxidative stress], and lipotoxicity, and lead to the development of metabolic syndrome.
      Previous work has shown that these comorbidities, as well as high levels of glucocorticoids,
      can modulate the hypothalamic-pituitary-adrenal (HPA) axis and inflammatory response. In some
      cases, these conditions and responses perturb neuroimmune endocrine system homeostasis.

      Another potential outcome arising from inflammation, insulin resistance, hyperglycemia, and
      lipotoxicity is a nonalcoholic fatty liver disease (NAFLD), a chronic liver disease that
      often coexists with obesity-related type 2 diabetes. Previous studies have demonstrated that
      NAFLD compromises glycemic and lipid homeostasis. The hyperglycemia and the lipotoxicity
      drive the metabolic pathways of the cell towards gluconeogenesis, glycolysis, and de novo
      lipogenesis, and the subsequent increase in free fatty acid (FFA) production can cause
      oxidative stress.

      Previous studies have shown that non-pharmacological interventions can be used as strategies
      for treating and/or preventing inflammatory and metabolic diseases. Furthermore, exploiting
      specific proteins and transcription factors that target the mitochondria represents potential
      mechanisms for these interventions.

      Along these lines, natural products and derivatives thereof, often referred to as natural
      medicines, have been gaining notoriety as sources of effective therapeutics. For example,
      polyphenols present in plants can be metabolized to form propionic acid, which is later
      transformed into another metabolite, butyrate. As reviewed by Juárez-Hernández et al.,
      Na-butyrate and synthetic derivatives thereof increase prebiotic lactobacilli and
      bifidobacteria growth in the colon, consequently improving thermogenesis and energy
      expenditure, ultimately reducing hepatic lipid deposition, improving triacylglycerol content
      and insulin resistance and protecting against metabolic impairment, as well as liver
      inflammation and/or damage. Furthermore, butyrate can induce the expression of fibroblast
      growth factor 21 (FGF-21), which plays a vital role in stimulating hepatic fatty acid
      β-oxidation. In this sense, prebiotics may be a promising treatment for chronic inflammatory
      and metabolic diseases in humans.

      The efficacy of prebiotic compounds, such as fructooligosaccharides (FOS),
      galacto-oligosaccharides (GOS) and yeast β-glucans, minerals including magnesium, zinc,
      selenium, and plants like Silybum marianum (L.) Gaerth. (Silymarin), have been evaluated for
      the treatment of specific diseases. However, most of these studies only describe the effects
      of the supplements being administered alone. Thus, the present study monitored the synergic
      effects of a novel supplement formulation containing prebiotics, yeast β-glucans, minerals,
      and silymarin on lipid metabolism, inflammatory and mitochondrial proteins in eutrophic, and
      overweight/obesity I volunteer.
    

Intervention name(s): Composition with Silymarin; Low-mineral composition without Silymarin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Volunteers will receive supplementation for 180 days. They took 4 capsules daily. Two capsules in the morning and two capsules at night.
There will be blood and feces collection at zero time, before supplementation, after 30, 90 and 180 days from the beginning of supplementation.; Volunteers will receive supplementation for 180 days. They took 4 capsules daily. Two capsules in the morning and two capsules at night.
There will be blood and feces collection at zero time, before supplementation, after 30, 90 and 180 days from the beginning of supplementation.
Other intervention name(s): Patent number: BR 10 2020 016156 3
Intervention MeSH terms: Silymarin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other