Beta-glucan and Immune Response to Influenza Vaccine : Yeast-derived Beta-glucan Supplementation on Antibody Response Following Influenza Vaccination: A Randomized, Placebo-controlled Study (M-Unity)
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..
Medienart: |
Klinische Studie |
---|
Erscheinungsjahr: |
2024 |
---|---|
Erschienen: |
2024 |
Enthalten in: |
ClinicalTrials.gov - (2024) vom: 19. März Zur Gesamtaufnahme - year:2024 |
---|
Sprache: |
Englisch |
---|
Links: |
Volltext [kostenfrei] |
---|
Themen: |
610 |
---|
Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: October 12, 2021, Last downloaded: ClinicalTrials.gov processed this data on March 27, 2024, Last updated: March 27, 2024 |
---|
Study ID: |
NCT05074303 |
---|---|
Veröffentlichungen zur Studie: |
|
fisyears: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
CTG000119938 |
---|
LEADER | 01000caa a22002652 4500 | ||
---|---|---|---|
001 | CTG000119938 | ||
003 | DE-627 | ||
005 | 20240327010342.0 | ||
007 | cr uuu---uuuuu | ||
008 | 240320s2024 xx |||||o 00| ||eng c | ||
035 | |a (DE-627)CTG000119938 | ||
035 | |a (UBBS_Klinische_Studien)NCT05074303 | ||
035 | |a (UBBS_Klinische_Studien)IRB202101959 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
245 | 1 | 0 | |a Beta-glucan and Immune Response to Influenza Vaccine |b Yeast-derived Beta-glucan Supplementation on Antibody Response Following Influenza Vaccination: A Randomized, Placebo-controlled Study (M-Unity) |
264 | 1 | |c 2024 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a Computermedien |b c |2 rdamedia | ||
338 | |a Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: October 12, 2021, Last downloaded: ClinicalTrials.gov processed this data on March 27, 2024, Last updated: March 27, 2024 | ||
520 | |a 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. | ||
650 | 2 | |a Influenza, Human | |
650 | 4 | |a Study Type: Interventional | |
650 | 4 | |a Recruitment Status: Active, not recruiting | |
650 | 4 | |a Phase: Phase 2 | |
650 | 4 | |a 610 | |
773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2024) vom: 19. März |
773 | 1 | 8 | |g year:2024 |g day:19 |g month:03 |
856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT05074303 |z kostenfrei |3 Volltext |
912 | |a GBV_CTG | ||
951 | |a AR | ||
952 | |j 2024 |b 19 |c 03 |