NCT05074303

Beta-glucan and Immune Response to Influenza Vaccine

Yeast-derived Beta-glucan Supplementation on Antibody Response Following Influenza Vaccination: A Randomized, Placebo-controlled Study (M-Unity)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Accepted

Summary

This trial in healthy adults will determine the effects of beta-glucan, a dietary fiber supplement isolated from baker's yeast, on immune response to the influenza vaccine.

Detailed description

Beta-glucans have been shown to enhance the innate and adaptive immune responses in cell cultures, animal models, and humans, thus adults over the age of 50 years receiving the influenza vaccination may benefit in terms of their immune response from supplementation with beta-glucans. This is a 6-week randomized, double-blind, placebo-controlled, 2-arm parallel study designed to evaluate the adjuvant effect of beta-glucan dietary supplementation during influenza vaccination. Participants will consume either the beta-glucan or placebo capsules for 42 days. Participants will complete an online Qualtrics daily questionnaire of compliance, fatigue, and cold and flu symptoms throughout the 42-day study. Influenza vaccine will be administered on or about day 14. The Gastrointestinal Symptom Rating Scale (GSRS) and the Mood and Feelings Questionnaire (MFQ) will be completed at baseline, 2 weeks and 6 weeks. Blood draws for antibody and cytokine response will be completed at baseline, and on or about days 14 and 15, and on day 42.

Conditions

• Healthy Aging

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Vaccine	All subjects will receive the influenza vaccine.
DIETARY_SUPPLEMENT	Beta-glucan	2 - 250 mg capsules/day of beta-glucan derived from Baker's yeast
DIETARY_SUPPLEMENT	Placebo	2 - 250 mg capsules/day of cellulose

Timeline

• Start date: 2022-07-18
• Primary completion: 2024-03-01
• Completion: 2024-08-28
• First posted: 2021-10-12
• Last updated: 2025-11-06
• Results posted: 2025-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study