Healthy Aging
Conditions
Keywords
beta-glucan; influenza; immunity; antibodies
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.
Interventions
BIOLOGICALInfluenza Vaccine
All subjects will receive the influenza vaccine.
DIETARY_SUPPLEMENTBeta-glucan
2 - 250 mg capsules/day of beta-glucan derived from Baker's yeast
DIETARY_SUPPLEMENTPlacebo
2 - 250 mg capsules/day of cellulose
Sponsors
Danstar Ferment AG
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Titer | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Cytokine Profile | 28 days (Day 0, Day 1, and Day 28) | Change in IFN-γ |
| Incidence of Influenza and Covid-19 | 28 days | Self-reported incidence of influenza and Covid-19 |
| Fever | 28 days | Number of subjects with self-reported fever |
| Cold and Flu Symptoms | 28 days | Score on the Modified Jackson Criteria rating scale from 0 (no symptoms) to 3 (severe symptoms). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Beta-glucan 500 mg/day beta-glucan
Influenza Vaccine: All subjects will receive the influenza vaccine.
Beta-glucan: 2 - 250 mg capsules/day of beta-glucan derived from Baker's yeast | 38 |
| Placebo 500 mg/day cellulose
Influenza Vaccine: All subjects will receive the influenza vaccine.
Placebo: 2 - 250 mg capsules/day of cellulose | 40 |
| Total | 78 |
Baseline characteristics
| Characteristic | Beta-glucan | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 71 years STANDARD_DEVIATION 9 | 71 years STANDARD_DEVIATION 10 | 71 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 75 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 35 Participants | 70 Participants | 35 Participants |
| Region of Enrollment United States | 38 participants | 78 participants | 40 participants |
| Sex: Female, Male Female | 24 Participants | 52 Participants | 28 Participants |
| Sex: Female, Male Male | 14 Participants | 26 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 40 |
| other Total, other adverse events | 0 / 38 | 0 / 40 |
| serious Total, serious adverse events | 0 / 38 | 0 / 40 |
Outcome results
Primary
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)
Population: A total of 40 participants were randomized to the placebo group and 38 to the beta-glucan group over two vaccination seasons. However, the antibody titer could only be analyzed in Season 1 (19 to placebo and 24 to beta-glucan) due to an ineffective influenza antigen source, which explains the discrepancy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Beta-glucan | Antibody Titer | Baseline (Mean of Day -14 and Day 0) | 127 Titer | Standard Deviation 105 |
| Beta-glucan | Antibody Titer | Intervention (Day 28) | 241 Titer | Standard Deviation 272 |
| Placebo | Antibody Titer | Baseline (Mean of Day -14 and Day 0) | 143 Titer | Standard Deviation 172 |
| Placebo | Antibody Titer | Intervention (Day 28) | 160 Titer | Standard Deviation 165 |
Secondary
Cold and Flu Symptoms
Score on the Modified Jackson Criteria rating scale from 0 (no symptoms) to 3 (severe symptoms).
Time frame: 28 days
Population: Cold and flu symptoms were monitored in all participants in Seasons 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Beta-glucan | Cold and Flu Symptoms | 0.92 Score on scale | Standard Deviation 0.07 |
| Placebo | Cold and Flu Symptoms | 0.70 Score on scale | Standard Deviation 0.06 |
Secondary
Fever
Number of subjects with self-reported fever
Time frame: 28 days
Population: This outcome was assessed on all participants in season 1 and season 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Beta-glucan | Fever | 1 Participants |
| Placebo | Fever | 1 Participants |
Secondary
Incidence of Influenza and Covid-19
Self-reported incidence of influenza and Covid-19
Time frame: 28 days
Population: This outcome was assessed on all participants in Season 1 and Season 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Beta-glucan | Incidence of Influenza and Covid-19 | 0 Participants |
| Placebo | Incidence of Influenza and Covid-19 | 0 Participants |
Secondary
Inflammatory Cytokine Profile
Change in IFN-γ
Time frame: 28 days (Day 0, Day 1, and Day 28)
Population: IFN-γ was analyzed in all participants in season 1 and season 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Beta-glucan | Inflammatory Cytokine Profile | Day 0 | 2.3 pg/mL | Standard Error 0.1 |
| Beta-glucan | Inflammatory Cytokine Profile | Day 1 | 8.2 pg/mL | Standard Error 1.7 |
| Beta-glucan | Inflammatory Cytokine Profile | Day 28 | 3.3 pg/mL | Standard Error 0.5 |
| Placebo | Inflammatory Cytokine Profile | Day 0 | 2.4 pg/mL | Standard Error 0.4 |
| Placebo | Inflammatory Cytokine Profile | Day 1 | 8.3 pg/mL | Standard Error 2.9 |
| Placebo | Inflammatory Cytokine Profile | Day 28 | 2.3 pg/mL | Standard Error 0.4 |