Antioxidant and Immunomodulatory Effect of a β-glucan Fiber From Saccharomyces Cerevisiae
Condition: Nutrition, Healthy
Study type: Interventional

Summary: 
      Β-glucans are linear polymers of glucose of high molecular weight that are found naturally in
      the cell wall of various living organisms such as bacteria, yeast, fungi and plants; They are
      widely used in food companies as texturizers.

      Scientific studies suggest that the consumption of β-glucans would be associated with
      benefits for human health such as reducing the risk of cardiovascular diseases and
      strengthening the immune system. These effects depend on their source of origin; those from
      cereals have been attributed beneficial metabolic properties and those that come from yeast
      immunostimulating properties.

      Yeast β-glucans are believed to be potent immunomodulators with effects on innate and
      adaptive immunity. This effect could be due to the ability to stimulate receptors of the
      immune system present in the membrane of enterocytes, M cells and dendritic cells, improving
      the phagocytic activity of macrophages and the antimicrobial activity of mononuclear cells
      and neutrophils.

      Due to this property, β-glucans are being used more and more for the development of
      functional foods in several countries of the world. However, the effect of yeast β-glucans on
      the stimulation of the immune response has not yet been accurately documented; Therefore, the
      present investigation aims to establish the performance of a β-glucan fiber from S.
      cerevisiae in antioxidant and immunomodulatory activity in healthy volunteers.
    

Detailed description: 
      Background

      Β-glucans are high molecular weight glucose polymers (polysaccharides) naturally present in
      the cell wall of various living organisms such as bacteria, yeast, fungi and plants. Some
      studies show that β-glucans have antioxidant activity and stimulate the immune system in
      animals and humans.

      On the other hand, the physiological metabolism in living beings generates free radicals that
      can endanger cell integrity if they are not controlled properly. Free radicals are
      collectively known as Reactive Oxygen Species (ROS) and have the ability to produce
      significant oxidative damage to cellular structures that can increase under environmental
      stress. Free radicals impair tissue function, contribute to aging and the development of
      chronic and chronic degenerative diseases.

      To counteract the action of free radicals, antioxidants are used whose function is to
      maintain or restore cellular balance. An alternative for this are β-glucans since they have
      protective properties against oxidative damage, the antioxidant effect they exert is indirect
      and is produced by improving the expression and production of antioxidant systems by the body
      itself.

      Various studies focused on antioxidant activity indicate that β-glucans from mushrooms
      constitute a potential natural source of antioxidants, especially associated with regular
      consumption.

      Added to the effects caused by ROS is the constant exposure of living beings to pathogens,
      which must be dealt with by the immune system through cells and tissues to avoid infections.
      The immune system, made up of the innate and the adaptive systems, is essential for survival
      as it protects the body against potentially dangerous microorganisms that constantly attack
      the human body. Therefore, the proper functioning of the immune system must be guaranteed,
      since limitations in it increase the possibility of contracting serious infections that
      threaten life. In accordance with this, it is reported that changes in dietary composition
      can improve immune function. Although studies have been reported in the literature since 1939
      on the response of the immune system by yeast cell walls, it is in the 1960s that it is
      established that the active substance in yeast that generates the beneficial effect is β
      -glucan. Β-glucans are known as biological response modifiers, due to their ability to
      activate the immune system, since they favor the participation of immune cells in a greater
      proportion in the face of external threats.

      In the same way, the scientific literature indicates that there are various properties
      attributed to the use of β-glucan, among them the decrease in allergy episodes, respiratory
      tract infections, decreased concentrations of glycoproteins of the immune system and
      increased potential of blood leukocytes to produce IL-2, IL-4, IL-5, and interferon (IFN-γ),
      the foregoing, suggesting that β-glucans hold promise for modulating an individual's immunity
      .

      In this sense, the company Levapan SA multilatina company of Colombian origin founded in
      1953, which is dedicated to the production and commercialization of yeast (S. cerevisiae),
      yeast extracts, flavor enhancers, raw materials for food industries, bakery and
      confectionery, mass consumption products, gastronomy, agribusiness, vegetable and animal
      proteins, has worked on the production of β-glucan from S. cerevisiae, showing potential
      effects on health.

      Within its portfolio, the product derived from yeast that is currently used as an ingredient
      in different formulations of the nutraceutical industry is presented as β-glucan Plus, since
      they offer immunostimulating properties. It is also considered that β-glucan may be a
      promising alternative to control or mitigate the effects of the SARS-CoV-2 virus responsible
      for the COVID-19 disease. However, it is necessary to evaluate and confirm the antioxidant
      and immunomodulatory effect of β-glucan Plus through a clinical evaluation as proposed by
      this research.

      Benefits of β-glucan

      Evidence supports that the inclusion of these polysaccharides in the diet can have positive
      effects on glycemic control, cholesterol and immunity. Due to their physical and chemical
      characteristics, they have been used during the development of functional foods to improve
      their texture and shelf life. Β-glucans are related to anti-inflammatory, antiviral,
      antioxidant, and immunomodulatory activity. Antimutagenic, chemoprotective and anticancer
      effects of these compounds have also been reported and they are reported to have positive
      effects on cardiovascular diseases, arteriosclerosis, diabetes, wound healing.

      Currently, β-glucan extracted from microorganisms is being used for the treatment of many
      diseases in the world. Processes have been carried out to extract β-glucans from the cell
      wall of S. cerevicie and develop products with it. However, work continues to obtain evidence
      to demonstrate its effectiveness through clinical studies.

      Global situation due to the COVID-19 pandemic

      The spread of the COVID-19 virus) has prompted interest in boosting immunity. With this
      perspective Kerry notes that clinical research has shown that his Wellmune β-glucan can help
      support upper respiratory tract infections. The company says it can support the immune system
      of people, including children, athletes, older adults and those with lifestyle stress.
      Wellmune notes that a healthy immune system is the best defense against disease, although
      there is no specific research demonstrating Wellmune's effectiveness against diseases like
      COVID-19.

      Treatments with β-glucan. At present there is an interest in promoting the immune response of
      organisms in a natural way, these facts have motivated the interest in conducting research on
      the immunomodulatory effect derived from natural systems. These scientific studies suggest
      that its consumption would be associated with benefits for human health such as reducing the
      risk of cardiovascular diseases and strengthening the immune system. These effects depend on
      their source of origin, those from cereals have been attributed beneficial metabolic
      properties and those that come from yeast immunostimulating properties; According to this
      theory, yeast β-glucans are believed to be potent immunomodulators with effects on innate and
      adaptive immunity. This effect could be due to the ability to stimulate receptors of the
      immune system present in the membrane of enterocytes, M cells and dendritic cells, improving
      the phagocytic activity of macrophages and the antimicrobial activity of mononuclear cells
      and neutrophils.

      Β-glucan from bakery yeast produced by Levapan S.A

      The β-glucan of Yeast Plus is a product of Levapan SA that contains 1,3 and 1,6 Β- Glucan
      extracted under hydrolysis processes of the cell wall of the yeast S. cerevisiae, where at
      the end of the process a product is obtained insoluble in water. The product is originated
      from non-genetically modified microorganisms, baker's yeast is the primary yeast made from
      sugar cane molasses. Annually the company produces approximately 20 Ton / month of β-glucan
      for its use in different formulations, such as the development of nutraceutical foods for
      human consumption, animal feed, aquaculture, among others.

      The β-glucan Plus is currently manufactured by Levapan S. A company that has the KOSHER,
      HALAL and ISO 9001: 2008 certifications for the production and preparation of glucan and is
      evaluated by PECET following the BPC protocols.

      There are extensive properties attributable to β-glucans that allow evaluating their actions
      in various fields, being used more and more for the development of functional foods in
      various countries of the world, but with few results that demonstrate the real effect of
      these.

      Due to these properties there are several studies focused on the effects of β-glucans,
      however, the effect of β-glucans from yeast S. cerevisiae on the stimulation of the immune
      response has not yet been accurately documented, so the This research aims to establish the
      performance of a S. cerevisiae β-glucan fiber in antioxidant and immunomodulatory activity in
      healthy volunteers.

      Due to the antioxidant and immunomodulatory activity of the different types of β-glucans,
      these are being used more and more for the development of functional foods in several
      countries of the world. However, the effect of yeast β-glucans on the stimulation of the
      immune response has not yet been accurately documented; Therefore, the present investigation
      aims to establish the performance of a β-glucan fiber from S. cerevisiae in antioxidant and
      immunomodulatory activity in healthy volunteers.

      OBJECTIVES OF THE STUDY

      General objective

      To determine the antioxidant and immunomodulatory effect of a β-glucan fiber obtained from
      the yeast S. cerevisiae in healthy adults.

      Specific objectives

        -  Determine the antioxidant activity of a β-glucan fiber obtained from S.cerevisiae

        -  To determine the strengthening of the immune system of a β-glucan fiber obtained from
           the yeast S. cerevisiae

        -  Evaluate the safety and tolerability (frequency, seriousness and degree of adverse
           events) of a β-glucan fiber obtained from the yeast S. cerevisiae

        -  Explore the metabolic benefit of a β-glucan fiber obtained from the yeast S. cerevisiae

        -  Explore the impact of the consumption of a β-glucan fiber obtained from the yeast S.
           cerevisiae on the severity of the SARS-CoV-2 coronavirus infection
    

Intervention name(s): Yeast β-glucan fiber; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The study is designed to determine if β-glucan is safe and if it presents an antioxidant and immunomodulatory response in healthy adults in Colombia.; oral consumption of 200 mg (one capsule) or 400 mg (two capsules) of soy protein powder for 84 days.
Other intervention name(s): β-glucan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is an interventional, randomized, non-comparative, exploratory, three-arm, double-blind, randomized study, divided into three groups (2 intervention and placebo) using an allocation ratio of 1: 1: 1.
Treatment allocation will be made according to a random code.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: B-glucan; Saccharomyces cerevisiae; Antioxidant; Inmunomodulador