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| Name | Class |
|---|---|
| Danstar Ferment AG | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta-glucan | Experimental | 500 mg/day beta-glucan |
|
| Placebo | Placebo Comparator | 500 mg/day cellulose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Vaccine | Biological | All subjects will receive the influenza vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 42 days (mean of Day -14 and 0 compared to Day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Cytokine Profile | Change in IFN-γ | 28 days (Day 0, Day 1, and Day 28) |
| Incidence of Influenza and Covid-19 | Self-reported incidence of influenza and Covid-19 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Food Science and Human Nutrition Department, University of Florida | Gainesville | Florida | 32611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40746014 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | 500 mg/day cellulose Influenza Vaccine: All subjects will receive the influenza vaccine. Placebo: 2 - 250 mg capsules/day of cellulose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Titer | 42 days (mean of Day -14 and 0 compared to Day 28) |
|
42 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wendy Dahl | University of Florida | 3522943707 | wdahl@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 21, 2023 | Feb 21, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D047071 | beta-Glucans |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Beta-glucan | Dietary Supplement | 2 - 250 mg capsules/day of beta-glucan derived from Baker's yeast |
|
| Placebo | Dietary Supplement | 2 - 250 mg capsules/day of cellulose |
|
| 28 days |
| Fever | Number of subjects with self-reported fever | 28 days |
| Cold and Flu Symptoms | Score on the Modified Jackson Criteria rating scale from 0 (no symptoms) to 3 (severe symptoms). | 28 days |
500 mg/day cellulose
Influenza Vaccine: All subjects will receive the influenza vaccine.
Placebo: 2 - 250 mg capsules/day of cellulose
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo |
500 mg/day cellulose Influenza Vaccine: All subjects will receive the influenza vaccine. Placebo: 2 - 250 mg capsules/day of cellulose |
|
|
| Secondary | Inflammatory Cytokine Profile | Change in IFN-γ | IFN-γ was analyzed in all participants in season 1 and season 2. | Posted | Jun 2025 | Mean | Standard Error | pg/mL | 28 days (Day 0, Day 1, and Day 28) |
|
|
|
| Secondary | Incidence of Influenza and Covid-19 | Self-reported incidence of influenza and Covid-19 | This outcome was assessed on all participants in Season 1 and Season 2. | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | Fever | Number of subjects with self-reported fever | This outcome was assessed on all participants in season 1 and season 2. | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | Cold and Flu Symptoms | Score on the Modified Jackson Criteria rating scale from 0 (no symptoms) to 3 (severe symptoms). | Cold and flu symptoms were monitored in all participants in Seasons 1 and 2. | Posted | Mean | Standard Deviation | Score on scale | 28 days |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Placebo | 500 mg/day cellulose Influenza Vaccine: All subjects will receive the influenza vaccine. Placebo: 2 - 250 mg capsules/day of cellulose | 0 | 40 | 0 | 40 | 0 | 40 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D005936 |
| Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| Day 28 |
|