NCT05074303

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

July 18, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2024

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 24, 2025

Completed
Last Updated

November 6, 2025

Status Verified

September 1, 2025

Enrollment Period

1.6 years

First QC Date

September 29, 2021

Results QC Date

January 31, 2025

Last Update Submit

October 23, 2025

Conditions

Healthy Aging

Keywords

beta-glucan; influenza; immunity; antibodies

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Inflammatory Cytokine Profile

    28 days (Day 0, Day 1, and Day 28)

  • Incidence of Influenza and Covid-19

    28 days

  • Fever

    28 days

  • Cold and Flu Symptoms

    28 days

Study Arms (2)

Beta-glucan

EXPERIMENTAL

500 mg/day beta-glucan

Biological: Influenza VaccineDietary Supplement: Beta-glucan

Placebo

PLACEBO COMPARATOR

500 mg/day cellulose

Biological: Influenza VaccineDietary Supplement: Placebo

Interventions

Influenza VaccineBIOLOGICAL

All subjects will receive the influenza vaccine.

Beta-glucanPlacebo
Beta-glucanDIETARY_SUPPLEMENT

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

Beta-glucan
PlaceboDIETARY_SUPPLEMENT

2 - 250 mg capsules/day of cellulose

Placebo

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Food Science and Human Nutrition Department, University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

  • 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.

    PMID: 40746014DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccinesbeta-Glucans

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex MixturesGlucansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Dr. Wendy Dahl
Organization
University of Florida
wdahl@ufl.edu
3522943707

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 12, 2021

Study Start

July 18, 2022

Primary Completion

March 1, 2024

Study Completion

August 28, 2024

Last Updated

November 6, 2025

Results First Posted

March 24, 2025

Record last verified: 2025-09

Locations

US(1)