Beta-glucan and Immune Response to Influenza Vaccine

Healthy Aging Clinical Trial

— M-Unity  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05074303
• Other study ID #: IRB202101959
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 18, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: October 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Aging
• Influenza, Human

Intervention

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
2 - 250 mg capsules/day of cellulose

Locations

Country	Name	City	State
United States	Food Science and Human Nutrition Department, University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Danstar Ferment AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody Titer	Change in influenza-specific antibodies (IgM, IgG influenza A and B) to the influenza vaccine after beta-glucan supplementation.	42 days (Day 1, Day 14, Day 15, and day 42)
Secondary	Inflammatory cytokine profile	Change in TNF-a, IL-1ß, IL-6, IL-8, MIP-1a and IFN-?	42 days (Day 1, Day 14, Day 15, and day 42)
Secondary	Incidence of influenza and Covid-19	Self-reported incidence of influenza and Covid-19	42 days
Secondary	Fever	Number of subjects with self-reported fever	42 days
Secondary	Cold and flu symptoms	Number of subjects with cold and flu symptoms using Modified Jackson Criteria	42 days