Beta-glucan and Immune Response to Influenza Vaccine (M-Unity)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Aging
• Intervention / Treatment: Biological: Influenza Vaccine; Dietary supplement: Beta-glucan; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Food Science and Human Nutrition Department, University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Adult volunteers ≥ 50 years of age.
2. Planning to be vaccinated for influenza
3. Have been immunized for COVID-19
4. Willing and able to provide written informed consent in English.
5. Willing and able to comply with all the study-related procedures, including attending to study visits for blood draw, taking the influenza vaccine, intake of the study supplement, and completing study questionnaires.

Exclusion Criteria:

1. Demonstrate an inability to comply with the study-related procedures.
2. Have a history of a severe reaction or hypersensitivity following vaccination with influenza vaccine, vaccination with any other vaccine containing the same substances, or intake of the study product.
3. Have an immune system alteration because of an underlying illness (e.g., autoimmune disease) or immune-suppressing treatment (e.g., steroids (last 30 days); cytotoxic drugs, medical surgery, or radiation therapy during the 6 months, previous to enrollment).
4. Be concurrently participating in a clinical trial that, in the judgement of the investigator, would interfere with the evaluation of the study outcomes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beta-glucan; 500 mg/day beta-glucan	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
Placebo Comparator: Placebo; 500 mg/day cellulose	Biological: Influenza Vaccine; All subjects will receive the influenza vaccine.; Dietary supplement: Placebo; 2 - 250 mg capsules/day of cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody Titer	Change in influenza-specific antibody influenza A titer to the influenza vaccine after beta-glucan supplementation. Titer from 0 to 1024; higher titer indicates stronger immune response.	42 days (mean of Day -14 and 0 compared to Day 28)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Cytokine Profile	Change in IFN-γ	28 days (Day 0, Day 1, and Day 28)
Incidence of Influenza and Covid-19	Self-reported incidence of influenza and Covid-19	28 days
Fever	Number of subjects with self-reported fever	28 days
Cold and Flu Symptoms	Score on the Modified Jackson Criteria rating scale from 0 (no symptoms) to 3 (severe symptoms).	28 days

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Danstar Ferment AG

Publications and helpful links

General Publications

• Moreno ML, Nieves CJ, Hebert K, Vivas CA, Rivero-Mendoza D, Colee J, Tompkins TA, Dahl WJ. Yeast Beta-Glucan Enhances Antibody Response Following Influenza Vaccination - A Double-Blind, Randomized, Placebo-Controlled Pilot Trial. J Diet Suppl. 2025;22(5):795-810. doi: 10.1080/19390211.2025.2539876. Epub 2025 Jul 31.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): August 28, 2024

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: October 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: beta-glucan; influenza; immunity; antibodies
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human; Carbohydrates; Polysaccharides; Biological Products; Complex Mixtures; Glucans; Vaccines; Viral Vaccines; Influenza Vaccines; beta-Glucans
• Other Study ID Numbers: IRB202101959

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No