search
Back to results

Beta-glucan and Immune Response to Influenza Vaccine (M-Unity)

Primary Purpose

Healthy Aging

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Influenza Vaccine
Beta-glucan
Placebo
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy Aging focused on measuring beta-glucan; influenza; immunity; antibodies

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Food Science and Human Nutrition Department, University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Beta-glucan

Placebo

Arm Description

500 mg/day beta-glucan

500 mg/day cellulose

Outcomes

Primary Outcome Measures

Antibody Titer
Change in influenza-specific antibodies (IgM, IgG influenza A and B) to the influenza vaccine after beta-glucan supplementation.

Secondary Outcome Measures

Inflammatory cytokine profile
Change in TNF-α, IL-1β, IL-6, IL-8, MIP-1α and IFN-γ
Incidence of influenza and Covid-19
Self-reported incidence of influenza and Covid-19
Fever
Number of subjects with self-reported fever
Cold and flu symptoms
Number of subjects with cold and flu symptoms using Modified Jackson Criteria

Full Information

First Posted
September 29, 2021
Last Updated
May 2, 2023
Sponsor
University of Florida
Collaborators
Danstar Ferment AG
search

1. Study Identification

Unique Protocol Identification Number
NCT05074303
Brief Title
Beta-glucan and Immune Response to Influenza Vaccine
Acronym
M-Unity
Official Title
Yeast-derived Beta-glucan Supplementation on Antibody Response Following Influenza Vaccination: A Randomized, Placebo-controlled Study (M-Unity)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Danstar Ferment AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Aging
Keywords
beta-glucan; influenza; immunity; antibodies

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Beta-glucan
Arm Type
Experimental
Arm Description
500 mg/day beta-glucan
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
500 mg/day cellulose
Intervention Type
Biological
Intervention Name(s)
Influenza Vaccine
Intervention Description
All subjects will receive the influenza vaccine.
Intervention Type
Dietary Supplement
Intervention Name(s)
Beta-glucan
Intervention Description
2 - 250 mg capsules/day of beta-glucan derived from Baker's yeast
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
2 - 250 mg capsules/day of cellulose
Primary Outcome Measure Information:
Title
Antibody Titer
Description
Change in influenza-specific antibodies (IgM, IgG influenza A and B) to the influenza vaccine after beta-glucan supplementation.
Time Frame
42 days (Day 1, Day 14, Day 15, and day 42)
Secondary Outcome Measure Information:
Title
Inflammatory cytokine profile
Description
Change in TNF-α, IL-1β, IL-6, IL-8, MIP-1α and IFN-γ
Time Frame
42 days (Day 1, Day 14, Day 15, and day 42)
Title
Incidence of influenza and Covid-19
Description
Self-reported incidence of influenza and Covid-19
Time Frame
42 days
Title
Fever
Description
Number of subjects with self-reported fever
Time Frame
42 days
Title
Cold and flu symptoms
Description
Number of subjects with cold and flu symptoms using Modified Jackson Criteria
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy J Dahl, PhD
Phone
352-294-3707
Email
wdahl@ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Rivero-Mendoza, MS
Phone
352-263-9136
Email
ufnutrition@ifas.ufl.edu
Facility Information:
Facility Name
Food Science and Human Nutrition Department, University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy J Dahl, PhD
Phone
352-294-3707
Email
wdahl@ufl.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Beta-glucan and Immune Response to Influenza Vaccine

We'll reach out to this number within 24 hrs