Trial Outcomes & Findings for Beta-glucan and Immune Response to Influenza Vaccine (NCT NCT05074303)

NCT ID: NCT05074303

Last Updated: 2025-11-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 78 participants
• Primary outcome timeframe: 42 days (mean of Day -14 and 0 compared to Day 28)
• Results posted on: 2025-11-06

Participant Flow

Participant milestones

Measure	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	Placebo 500 mg/day cellulose Influenza Vaccine: All subjects will receive the influenza vaccine. Placebo: 2 - 250 mg capsules/day of cellulose
Overall Study STARTED	38	40
Overall Study COMPLETED	38	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Beta-glucan and Immune Response to Influenza Vaccine

Baseline characteristics by cohort

Measure	Beta-glucan n=38 Participants 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	Placebo n=40 Participants 500 mg/day cellulose Influenza Vaccine: All subjects will receive the influenza vaccine. Placebo: 2 - 250 mg capsules/day of cellulose	Total n=78 Participants Total of all reporting groups
Race (NIH/OMB) Asian	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Black or African American	1 Participants n=49 Participants	3 Participants n=50 Participants	4 Participants n=50 Participants
Race (NIH/OMB) White	35 Participants n=49 Participants	35 Participants n=50 Participants	70 Participants n=50 Participants
Race (NIH/OMB) More than one race	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=49 Participants	2 Participants n=50 Participants	4 Participants n=50 Participants
Region of Enrollment United States	38 participants n=49 Participants	40 participants n=50 Participants	78 participants n=50 Participants
Age, Continuous	71 years STANDARD_DEVIATION 9 • n=49 Participants	71 years STANDARD_DEVIATION 11 • n=50 Participants	71 years STANDARD_DEVIATION 10 • n=50 Participants
Sex: Female, Male Female	24 Participants n=49 Participants	28 Participants n=50 Participants	52 Participants n=50 Participants
Sex: Female, Male Male	14 Participants n=49 Participants	12 Participants n=50 Participants	26 Participants n=50 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=49 Participants	39 Participants n=50 Participants	75 Participants n=50 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=49 Participants	1 Participants n=50 Participants	3 Participants n=50 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Beta-glucan n=24 Participants 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	Placebo n=19 Participants 500 mg/day cellulose Influenza Vaccine: All subjects will receive the influenza vaccine. Placebo: 2 - 250 mg capsules/day of cellulose
Antibody Titer Baseline (Mean of Day -14 and Day 0)	127 Titer Standard Deviation 105	143 Titer Standard Deviation 172
Antibody Titer Intervention (Day 28)	241 Titer Standard Deviation 272	160 Titer Standard Deviation 165

SECONDARY outcome

Timeframe: 28 days (Day 0, Day 1, and Day 28)

Population: IFN-γ was analyzed in all participants in season 1 and season 2.

Change in IFN-γ

Outcome measures

Measure	Beta-glucan n=38 Participants 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	Placebo n=40 Participants 500 mg/day cellulose Influenza Vaccine: All subjects will receive the influenza vaccine. Placebo: 2 - 250 mg capsules/day of cellulose
Inflammatory Cytokine Profile Day 0	2.3 pg/mL Standard Error 0.1	2.4 pg/mL Standard Error 0.4
Inflammatory Cytokine Profile Day 1	8.2 pg/mL Standard Error 1.7	8.3 pg/mL Standard Error 2.9
Inflammatory Cytokine Profile Day 28	3.3 pg/mL Standard Error 0.5	2.3 pg/mL Standard Error 0.4

SECONDARY outcome

Timeframe: 28 days

Population: This outcome was assessed on all participants in Season 1 and Season 2.

Self-reported incidence of influenza and Covid-19

Outcome measures

Measure	Beta-glucan n=38 Participants 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	Placebo n=40 Participants 500 mg/day cellulose Influenza Vaccine: All subjects will receive the influenza vaccine. Placebo: 2 - 250 mg capsules/day of cellulose
Incidence of Influenza and Covid-19	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days

Population: This outcome was assessed on all participants in season 1 and season 2.

Number of subjects with self-reported fever

Outcome measures

Measure	Beta-glucan n=38 Participants 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	Placebo n=40 Participants 500 mg/day cellulose Influenza Vaccine: All subjects will receive the influenza vaccine. Placebo: 2 - 250 mg capsules/day of cellulose
Fever	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Cold and flu symptoms were monitored in all participants in Seasons 1 and 2.

Score on the Modified Jackson Criteria rating scale from 0 (no symptoms) to 3 (severe symptoms).

Outcome measures

Measure	Beta-glucan n=38 Participants 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	Placebo n=40 Participants 500 mg/day cellulose Influenza Vaccine: All subjects will receive the influenza vaccine. Placebo: 2 - 250 mg capsules/day of cellulose
Cold and Flu Symptoms	0.92 Score on scale Standard Deviation 0.07	0.70 Score on scale Standard Deviation 0.06

Adverse Events

Beta-glucan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Wendy Dahl

University of Florida

Phone: 3522943707

Email: wdahl@ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place