Effects of Yeast (1,3)-(1,6)-beta-glucan on immune defence against pathogens of upper respiratory tract infections: a double-blind, randomized, placebo-controlled, monocentric study in healthy subjects

Not Applicable

• Conditions: pper respiratory tract infections

• Registration Number: DRKS00010954
• Lead Sponsor: eiber GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-17
• Study Completion: 2017-04-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

body mass index (BMI): 18.5 - 32 kg/m²
- at least 3 common cold episodes within the last 12 months
- subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- not anticipating any planned changes in lifestyle regarding activity, nutrition, sleep habits and / or expected stress level
- subject is in good physical and mental health

Exclusion Criteria

- intake of medications or food supplements with influence on the immune system or anti-inflammatory products
- chronic respiratory illness (e.g. chronic cough, chronic rhinitis)
- allergies that may influence the upper respiratory tract (e.g. allergic rhinitis, allergic asthma)
- gastorintestinal diseases / conditions (e.g. colitis ulcerosa, Crohn's IBS, IBD, peptic ulcers, celiac disease)
- Influenza vaccination within the previous three weeks prior to or during the trial
- vegans
- heavy smoker > 15 cigarettes / day
- known drug, alcohol or medication abuses
- known pregnancy, breast feeding or intention to become pregnant during the study
- Blood donation within 4 weeks prior to trial start or during trial

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global severity (AUC) of common cold symptoms (WURSS-21 questionnaire) over a period of 16 weeks and comparison between groups

Secondary Outcome Measures

Name	Time	Method
Comparison between groups regarding incidence, severity and duration of upper respiratory tract infections over an intervention period of 16 weeks. The parameters are recorded via questionnaire and clinically confirmed.