Beta-glucan and Immune Response to Influenza Vaccine

University of Florida78 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Healthy Aging

Interventions

Influenza VaccineBIOLOGICAL

All subjects will receive the influenza vaccine.

Beta-glucanDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

2 - 250 mg capsules/day of cellulose

Eligibility

Sex: ALLMin age: 50 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Food Science and Human Nutrition Department, University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Inflammatory Cytokine Profile

Change in IFN-γ

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

Incidence of Influenza and Covid-19

Self-reported incidence of influenza and Covid-19

Time frame: 28 days

Fever

Number of subjects with self-reported fever

Time frame: 28 days

Cold and Flu Symptoms

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

Time frame: 28 days

Data from ClinicalTrials.gov

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