Antioxidant and Immunomodulatory Effect of a β-glucan Fiber From Saccharomyces Cerevisiae

NCT05097313 | Completed DMC

• 1 other identifier: PEC02_2020
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nutrition, Healthy

Keywords

B-glucan; Saccharomyces cerevisiae; Antioxidant; Inmunomodulador

Outcome Measures

Primary Outcomes (2)

• Antioxidant capacity

  Evaluation of antioxidant capacity of β-glucan Fiber through analysis of results of tests from Baseline level compared to day 42, day 84 and day 140.

  Day 140

• Immunomodulatory capacity

  Evaluation of immunomodulatory capacity of β-glucan Fiber through analysis of results of tests from Baseline level compared to day 42, day 84 and day 140.

  Day 140

Secondary Outcomes (2)

• Metabolic benefit

  Day 140

• Metabolid benefit

  Day 140

Study Arms (3)

consumption of 250 mg of β-glucan

EXPERIMENTAL

Patients with oral consumption of 250 mg (one capsule) of β-glucan from Yeast Plus once a day for 84 days without interruption.

Dietary Supplement: Yeast β-glucan fiber

consumption of 500 mg of β-glucan

EXPERIMENTAL

Patients with oral consumption of 500 mg (two capsules) of β-glucan from Yeast Plus once a day for 84 days without interruption.

Dietary Supplement: Yeast β-glucan fiber

200 mg or 400 mg placebo

PLACEBO COMPARATOR

Placebo patients, with oral soy protein consumption, half of the group 200 mg (one capsule) and the remaining 400 mg (two capsules) once a day for 84 days without interruption

Other: Placebo

Interventions

Yeast β-glucan fiber DIETARY_SUPPLEMENT

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.

Also known as: β-glucan

consumption of 250 mg of β-glucan; consumption of 500 mg of β-glucan

Placebo OTHER

oral consumption of 200 mg (one capsule) or 400 mg (two capsules) of soy protein powder for 84 days.

200 mg or 400 mg placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged ≥18 and ≤45 years without abnormal findings at the time of physical examination
• Tests of creatinine, transaminases, lipid profile, glycemia and hemogram with ranges of normality according to laboratory reference values and / or at the discretion of the researcher
• Body Mass Index (BMI) between 18.5 and 25 kg / m2
• In the opinion of the researcher, the participant is able to understand and comply with the protocol

You may not qualify if:

• Women with a positive pregnancy test during the screening process or who do not agree with the use of a contraceptive method until day 90 post-treatment
• Women who are breastfeeding
• Clinically significant pathological history such as kidney disease, hypertension, diabetes, anemia, autoimmune or psychiatric diseases, among others that may affect the development or results of the study.
• Manifest eating styles other than the omnivore
• Have food restrictions derived from allergic, metabolic, dermatological diseases, lithiasis, irritable bowel and / or health conditions that imply permanent modification in diet
• Consumption of a vitamin or nutritional supplement
• Any condition that, in the opinion of the investigator, may affect the development of the study.

Sponsors & Collaborators

• Universidad de Antioquia: lead
• Levapan S.A: collaborator

Study Sites (1)

Program for Research and Control in Tropical Diseases - PECET

Medellín, Antioquia, 0004, Colombia

Location

Related Publications (19)

• Del Corno M, Gessani S, Conti L. Shaping the Innate Immune Response by Dietary Glucans: Any Role in the Control of Cancer? Cancers (Basel). 2020 Jan 8;12(1):155. doi: 10.3390/cancers12010155.

  PMID: 31936360 BACKGROUND

• Pérez-Guisado J. Arguments in favor of incorporating β-D-glucans in food. Endocrinología y Nutrición. 2007;54(6):315-24.

  BACKGROUND

• Divya M, Gopi N, Iswarya A, Govindarajan M, Alharbi NS, Kadaikunnan S, Khaled JM, Almanaa TN, Vaseeharan B. beta-glucan extracted from eukaryotic single-celled microorganism Saccharomyces cerevisiae: Dietary supplementation and enhanced ammonia stress tolerance on Oreochromis mossambicus. Microb Pathog. 2020 Feb;139:103917. doi: 10.1016/j.micpath.2019.103917. Epub 2019 Dec 10.

  PMID: 31830581 BACKGROUND

• Antioxidant Effect of Beta-glucan Extract from Saccharomyces Cerevisiae. Indian Journal of Forensic Medicine & Toxicology. 2020.

  BACKGROUND

• Vetvicka V, Vannucci L, Sima P, Richter J. Beta Glucan: Supplement or Drug? From Laboratory to Clinical Trials. Molecules. 2019 Mar 30;24(7):1251. doi: 10.3390/molecules24071251.

  PMID: 30935016 BACKGROUND

• Carvajal Carvajal C. Reactive oxygen species: formation, function and oxidative stress. Legal Medicine of Costa Rica. 2019; 36: 91-100.

  BACKGROUND

• Özcan Ö, Ertan F. Beta-glucan Content, Antioxidant and Antimicrobial Activities of Some Edible Mushroom Species. Food Science and Technology. 2018;6(2):47-55.

  BACKGROUND

• Zrnic-Ciric M, Dabetic N, Todorovic V, Djuris J, Vidovic B. Beta-glucan content and antioxidant activities of mushroom-derived food supplements. Journal of the Serbian Chemical Society. 2020;85(4):439-51.

  BACKGROUND

• Song H-S, Moon K-Y. In vitro antioxidant activity profiles of ${\beta} $-glucans isolated from yeast Saccharomyces cerevisiae and mutant Saccharomyces cerevisiae IS2. Food Science and Biotechnology. 2006;15(3):437-40.

  BACKGROUND

• Volman JJ, Mensink RP, Ramakers JD, de Winther MP, Carlsen H, Blomhoff R, Buurman WA, Plat J. Dietary (1-->3), (1-->4)-beta-D-glucans from oat activate nuclear factor-kappaB in intestinal leukocytes and enterocytes from mice. Nutr Res. 2010 Jan;30(1):40-8. doi: 10.1016/j.nutres.2009.10.023.

  PMID: 20116659 BACKGROUND

• Carpenter KC, Breslin WL, Davidson T, Adams A, McFarlin BK. Baker's yeast beta-glucan supplementation increases monocytes and cytokines post-exercise: implications for infection risk? Br J Nutr. 2013 Feb 14;109(3):478-86. doi: 10.1017/S0007114512001407. Epub 2012 May 10.

  PMID: 22575076 BACKGROUND

• Pizarro C S, Ronco M AM, Gotteland R M. ß-glucans: what types are there and what are their health benefits? Chilean nutrition magazine. 2014; 41: 439-46.

  BACKGROUND

• Talbott SM, Talbott JA, Talbott TL, Dingler E. beta-Glucan supplementation, allergy symptoms, and quality of life in self-described ragweed allergy sufferers. Food Sci Nutr. 2013 Jan;1(1):90-101. doi: 10.1002/fsn3.11. Epub 2014 Jan 8.

  PMID: 24804018 BACKGROUND

• Kirmaz C, Bayrak P, Yilmaz O, Yuksel H. Effects of glucan treatment on the Th1/Th2 balance in patients with allergic rhinitis: a double-blind placebo-controlled study. Eur Cytokine Netw. 2005 Jun;16(2):128-34.

  PMID: 15941684 BACKGROUND

• Espinoza-Gallardo D, Contreras-Porcia L, Ehrenfeld N. ß-glucans, their production and properties in microalgae with emphasis on the genus Nannochloropsis (Ochrophyta, Eustigmatales). Journal of Marine Biology and Oceanography. 2017; 52 (1): 33-49.

  BACKGROUND

• San Mauro-Martín I, Garicano Vilar E. Role of vitamin C and β-glucans on the immune system: review. Spanish Journal of Human Nutrition and Dietetics. 2015; 19 (4): 238.

  BACKGROUND

• Lazaridou A, Biliaderis CG. Molecular aspects of cereal β-glucan functionality: Physical properties, technological applications and physiological effects. J Cereal Sci. 2007;46(2):101-18.

  BACKGROUND

• Vásquez-Piñeros MA, Rondón-Barragan IS, Eslava-Mocha PR. Immunostimulants in teleost fish: probiotics, B-glucans and lipopolysaccharides. Orinoquia. 2012;16(1):46-62.

  BACKGROUND

• Brennan CS CL. The potential use of cereal (1→3,1→4)-β-d-glucans as functional food ingredients. J Cereal Sci. 2005;42(1):1-13.

  BACKGROUND

Related Links

• TERRA HD. Beta-glucans: immune regulators and cardiovascular protectors 2019
• nutritioninsight. Lallemand Bio-Ingredients adquiere Biotec BetaGlucans para expandir la estrategia de levadura beta-glucano 2020

Study Officials

• Iván D Vélez, MD. PhD.

  Director PECET

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind trial. Research product blinding will be maintained using one label for both products (fiber and placebo) and the same capsules for both. Subjects, who collect the data (eg, Investigator and coordinator) and those who evaluate the data (eg, Statistician) will be blinded. One or more pharmacists / vaccine administrators designated by the facility will not be blinded. These designated unblinded individuals will maintain investigational vaccine blindness and will not participate in the safety assessment of the subjects.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: October 28, 2021
• Study Start: August 27, 2021
• Primary Completion: February 7, 2022
• Study Completion: May 18, 2022
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)