Skip to main content
OpenTrials
Completed

NCT Number: NCT05074303

Beta-glucan and Immune Response to Influenza Vaccine

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Food Science and Human Nutrition Department, University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult volunteers ≥ 50 years of age.
  • Planning to be vaccinated for influenza
  • Have been immunized for COVID-19
  • Willing and able to provide written informed consent in English.
  • 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

  • Demonstrate an inability to comply with the study-related procedures.
  • 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.
  • 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).
  • Be concurrently participating in a clinical trial that, in the judgement of the investigator, would interfere with the evaluation of the study outcomes.

Treatment and study plan

influenza vaccine

Biological

All subjects will receive the influenza vaccine.

beta-glucan

Dietary Supplement

2 - 250 mg capsules/day of beta-glucan derived from Baker's yeast

Placebo

Dietary Supplement

2 - 250 mg capsules/day of cellulose

Primary outcomes

  1. Antibody Titer

    Time frame: 42 days (mean of Day -14 and 0 compared to Day 28)

    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.

Secondary outcomes

  1. Inflammatory Cytokine Profile

    Time frame: 28 days (Day 0, Day 1, and Day 28)

    Change in IFN-γ

  2. Incidence of Influenza and Covid-19

    Time frame: 28 days

    Self-reported incidence of influenza and Covid-19

  3. Fever

    Time frame: 28 days

    Number of subjects with self-reported fever

  4. Cold and Flu Symptoms

    Time frame: 28 days

    Score on the Modified Jackson Criteria rating scale from 0 (no symptoms) to 3 (severe symptoms).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Danstar Ferment AG

Registry information

Official study title

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

Acronym: M-Unity

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2021
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.