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Nutraceutical Composition Containing Natural Products Derivatives on the Modulation of the Endocrine Neuroimmune Axis

Last Updated: 2024-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-20

Study Completion Date

2022-12-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Insulin Resistance Inflammatory Bowel Diseases Overweight and Obesity Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1 - composition with Silymarin (L5-Plus)

This group compound with healthy and overweight/obese-I will receive the composition with Silymarin (Silybum marianum), in a diary dose of 140 mg for 180 days.

The formulation of the supplement/composition (Patent number: BR 10 2020 016156 3).

Group Type ACTIVE_COMPARATOR