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

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 - BTS963/16

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010954

Enrollment

288

Registered

2016-08-17

Start date

2016-10-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper respiratory tract infections

Interventions

Group 1: verum group (yeast beta-glucan), oral 2x 1capsule/day à 450 mg, intervention time: 16 weeks Group 2: placebo group (Maltodextrin) oral 2x 1capsule/day à 450 mg, intervention time: 16 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

Germany

Contacts

Public ContactTanita Dharsono

BioTeSys GmbH

m.studie@bioteys.de+49 (0) 711/3513835

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026