Food Science and Human Nutrition Department, University of Florida
Gainesville, Florida, 32611, United States
NCT Number: NCT05074303
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.
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Notify Me50 year–100 year
All sexes
Interventional
Phase 2
Gainesville, Florida, 32611, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All subjects will receive the influenza vaccine.
2 - 250 mg capsules/day of beta-glucan derived from Baker's yeast
2 - 250 mg capsules/day of cellulose
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.
Time frame: 28 days (Day 0, Day 1, and Day 28)
Change in IFN-γ
Time frame: 28 days
Self-reported incidence of influenza and Covid-19
Time frame: 28 days
Number of subjects with self-reported fever
Time frame: 28 days
Score on the Modified Jackson Criteria rating scale from 0 (no symptoms) to 3 (severe symptoms).
University of Florida
Other
Yeast-derived Beta-glucan Supplementation on Antibody Response Following Influenza Vaccination: A Randomized, Placebo-controlled Study (M-Unity)
Acronym: M-Unity
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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