Healthy AgingPhase 2M-UnityNCT05074303
Beta-glucan and Immune Response to Influenza Vaccine
A Phase 2 study testing Influenza Vaccine and Beta-glucan in people with Healthy Aging, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Influenza Vaccine and Beta-glucan
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2022to 28 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Food Science and Human Nutrition Department, University of Florida
Gainesville, Florida, 32611
About this study
Official title: Yeast-derived Beta-glucan Supplementation on Antibody Response Following Influenza Vaccination: A Randomized, Placebo-controlled Study (M-Unity)
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.
Read the 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.
- Conditions
- Healthy Aging
- Being tested
- Influenza Vaccine, Beta-glucan, Placebo
- Keywords
- beta-glucan; influenza; immunity; antibodies
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Beta-glucan | Experimental | 500 mg/day beta-glucan Receives: Biological: Influenza Vaccine; Dietary Supplement: Beta-glucan |
| Placebo | Placebo comparator | 500 mg/day cellulose Receives: Biological: Influenza Vaccine; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 42 days (mean of Day -14 and 0 compared to Day 28)
Secondary outcomes (4)
Inflammatory Cytokine Profile
Change in IFN-γ
Measured: 28 days (Day 0, Day 1, and Day 28)
Incidence of Influenza and Covid-19
Self-reported incidence of influenza and Covid-19
Measured: 28 days
Fever
Number of subjects with self-reported fever
Measured: 28 days
Cold and Flu Symptoms
Score on the Modified Jackson Criteria rating scale from 0 (no symptoms) to 3 (severe symptoms).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start18 Jul 2022
- Primary completion1 Mar 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Danstar Ferment AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074303
- Sponsor's protocol ID
- IRB202101959
- Acronym
- M-Unity
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2021
- Last updated
- 6 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40746014
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yeast-derived Beta-glucan Supplementation on Antibody Response Following Influenza Vaccination: A Randomized, Placebo-controlled Study (M-Unity)
- ClinicalTrials.gov ID
- NCT05074303
- Acronym / sponsor ID
- M-Unity / IRB202101959
- Conditions
- Healthy Aging
- Keywords
- beta-glucan; influenza; immunity; antibodies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Danstar Ferment AG
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Posted 24 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-glucan | Experimental | Biological: Influenza Vaccine, Dietary Supplement: Beta-glucan500 mg/day beta-glucan |
| Placebo | Placebo comparator | Biological: Influenza Vaccine, Dietary Supplement: Placebo500 mg/day cellulose |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza VaccineAll subjects will receive the influenza vaccine. | Biological | Beta-glucan, Placebo |
| Beta-glucan2 - 250 mg capsules/day of beta-glucan derived from Baker's yeast | Dietary supplement | Beta-glucan |
| Placebo2 - 250 mg capsules/day of cellulose | Dietary supplement | Placebo |
Primary outcome
Antibody Titer
Time frame: 42 days (mean of Day -14 and 0 compared to Day 28)
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.
4 secondary outcomes
Inflammatory Cytokine Profile
Time frame: 28 days (Day 0, Day 1, and Day 28)
Incidence of Influenza and Covid-19
Time frame: 28 days
Fever
Time frame: 28 days
Cold and Flu Symptoms
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40746014Moreno 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Influenza Vaccine and Beta-glucan in people with Healthy Aging, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody Titer (time frame: 42 days (mean of Day -14 and 0 compared to Day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05074303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.