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Beta-glucan and Immune Response to Influenza Vaccine

NCT ID: NCT05074303

Last Updated: 2025-11-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-18

Study Completion Date

2024-08-28

Brief Summary

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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

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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

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Healthy Aging

Keywords

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beta-glucan; influenza; immunity; antibodies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Beta-glucan

500 mg/day beta-glucan

Group Type EXPERIMENTAL

Influenza Vaccine

Intervention Type BIOLOGICAL

All subjects will receive the influenza vaccine.

Beta-glucan

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

500 mg/day cellulose

Group Type PLACEBO_COMPARATOR

Influenza Vaccine

Intervention Type BIOLOGICAL

All subjects will receive the influenza vaccine.

Placebo

Intervention Type DIETARY_SUPPLEMENT

2 - 250 mg capsules/day of cellulose

Interventions

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Influenza Vaccine

All subjects will receive the influenza vaccine.

Intervention Type BIOLOGICAL

Beta-glucan

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 - 250 mg capsules/day of cellulose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danstar Ferment AG

UNKNOWN

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Food Science and Human Nutrition Department, University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40746014 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB202101959

Identifier Type: -

Identifier Source: org_study_id