(P30-036-24) Yeast-Derived Beta-Glucan Supplementation on Antibody Response Following Influenza Vaccination: A Protocol for a Randomized, Placebo-Controlled Study (M-Unity)

Objectives: Yeast beta-glucans have shown immune-modulating effects by enhancing innate and adaptive immune responses through cytokine release and antibody production, among other immunomodulating effects. This study aims to determine the effect of yeast-derived beta-glucan supplementation on antibody titer response to influenza vaccination. Secondary outcomes include cytokine profile, incidence of fever, cold and flu symptoms, and self-perceived fatigue.

Methods: This is a 2-arm parallel, randomized, placebo-controlled study, recruiting 90 adults (45 per arm) ≥ 50 years of age planning to be vaccinated for seasonal influenza. Exclusion includes a history of a severe reaction or hypersensitivity to vaccination or the investigational products, and currently on immune-suppression therapy. Participants will be randomized to either 500 mg of yeast beta-glucan or placebo (cellulose) supplementation at 2 capsules daily for 28 days. Following an initial blood draw, participants will receive the seasonal influenza vaccination, a second blood draw within 24-48 hours, and a final blood draw on day 28. Participants will complete a daily questionnaire on compliance, cold and flu symptoms by the Modified Jackson Criteria, and self-perceived fatigue. Adverse events will be queried. Influenza-specific serum antibody titers will be determined using a hemagglutination inhibition assay and plasma cytokine profile by Luminexâ. Two-sided tests will be used to test the hypothesis, and a linear model (α = 0.05). Primary and secondary outcomes will be tested by comparing between-group differences from baseline.

Results: We hypothesize that concurrent yeast beta-glucan supplementation will elicit an enhanced cytokine response and a more robust antibody titer following seasonal influenza vaccination. Additionally, we hypothesize that yeast beta-glucan supplementation will reduce perceived fatigue.

Conclusions: The findings of this study will add to the body of literature regarding the immune-modulating effects of yeast beta-glucan, specifically for the enhancement of immune response to seasonal influenza vaccination.

Funding Sources: Danstar Ferment A.G., Switzerland