Study of the Preventive Effects and Mechanisms of Yeast β-Glucan on Upper Respiratory Tract Infections

NCT ID: NCT07085858

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-25
• Study Completion Date: 2026-12-31

Brief Summary

This study is designed as a randomized, double-blind, placebo-controlled human intervention trial targeting a population of university students with persistent allergic rhinitis (AR) symptoms. The primary objective is to evaluate the preventive effect and underlying mechanisms of yeast β-glucan on upper respiratory tract infections (URTIs), providing scientific evidence for the prophylactic use of prebiotics in high-risk populations.

All participants will be stratified by sex and body mass index (BMI), and then randomly assigned to either the yeast β-glucan group or the control group. During the 15-week study period-including a 1-week run-in phase, a 12-week intervention phase, and a 2-week follow-up phase-participants in the intervention group will take two yeast β-glucan capsules daily after meals, while the control group will take two placebo capsules with identical appearance, taste, and packaging.

Participants will be monitored daily for the occurrence of URTIs. In the event of an infection, the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) will be used to assess symptom severity and duration. Medication use, including dosage, frequency, and timing, will also be recorded. Weekly follow-ups will assess changes in Total Nasal Symptom Score (TNSS), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and adverse events. In addition, participants will undergo comprehensive follow-up assessments at Week 0 and Week 12, including TNSS and RQLQ questionnaires, a 3-day dietary intake survey, anthropometric measurements (e.g., height, weight, body fat percentage), and biological sample collection (blood, urine, and stool samples).

Detailed Description

Upper respiratory tract infections (URTIs) are acute mucosal infectious diseases caused by the invasion of respiratory mucosa by pathogens, which disrupt the mucosal barrier, activate the immune system, and trigger inflammatory responses. Clinical symptoms include nasal congestion, rhinorrhea, sore throat, cough, and hoarseness. Although URTIs are generally self-limiting, their high incidence, recurrence, and transmissibility-especially in crowded settings such as schools and workplaces-pose a significant public health burden. Allergic rhinitis (AR) is a chronic upper airway inflammatory disease mediated by immunoglobulin E (IgE), with typical symptoms such as nasal itching, sneezing, clear rhinorrhea, and nasal congestion. In AR patients, the nasal mucosa remains in a persistent inflammatory state, with impaired epithelial barrier function, reduced ciliary activity, and decreased local secretory IgA (sIgA) production. These alterations weaken the mucosal immune defense against viruses and bacteria, making AR patients more prone to recurrent URTIs. Furthermore, the seasonal onset of AR often coincides with peak URTI incidence, further compounding the risk of infection. Therefore, individuals with AR are considered a susceptible population for URTIs and are ideal targets for evaluating preventive interventions.

This study is designed as a randomized, double-blind, placebo-controlled human intervention trial among university students with persistent AR symptoms. The aim is to evaluate the preventive effect and underlying mechanisms of yeast β-glucan on URTIs, providing scientific evidence for the prophylactic application of prebiotics in high-risk populations. A total of 96 participants with persistent AR symptoms will be recruited and stratified by sex and BMI before being randomly assigned to either the yeast β-glucan group (n=48) or the placebo group (n=48). Blinding will be applied to both participants and investigators. Only the study designers will have access to the randomization codes. All intervention products and samples will be labeled with coded identifiers to prevent unblinding. If a participant experiences a serious adverse event related to the intervention, unblinding will be permitted, and the participant will be withdrawn from the study.

The yeast β-glucan used in this study is provided by Angel Yeast Co., Ltd. In 2010, China's Ministry of Health approved yeast β-glucan as a novel food ingredient for use in general food products, indicating its established safety. Nevertheless, adverse events will be closely monitored throughout the study and reported in accordance with ethical requirements.

During the intervention period, participants in the intervention group will take two yeast β-glucan capsules daily, each containing 250 mg of yeast β-glucan along with maltodextrin and silicon dioxide. The placebo group will receive identical capsules in terms of form, taste, appearance, and packaging, containing only maltodextrin and a small amount of silicon dioxide. All participants will take two capsules once daily after meals with warm water. Participants will be monitored daily for the occurrence of URTIs. If URTIs occur, the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) will be used to assess symptom severity and duration, and medication use (number of doses, dosage, and timing) will be recorded. Weekly follow-ups will be conducted to assess Total Nasal Symptom Score (TNSS), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and adverse events. At weeks 0 and 12, participants will complete questionnaire assessments (TNSS, RQLQ), a dietary intake survey, anthropometric measurements (e.g., height, weight, body fat percentage), and biological sample collection (blood, urine, and feces).

The primary outcome of this study is the incidence of URTIs. Secondary outcomes include: WURSS-24 (URTI symptom severity and duration), TNSS (nasal symptom score), RQLQ (quality of life assessment for rhinoconjunctivitis) ,Inflammatory cytokines (IFN-γ, IL-4, IL-10, IL-6, TNF-α) Serum biochemical markers(CRP, ALT/AST, BUN/Cr) and Fecal biomarkers (microbiota composition, SCFAs). Data will be analyzed using SAS 9.4 software. Continuous variables will be expressed as mean ± standard deviation; ordinal variables will be presented as percentages. Independent sample t-tests or Kruskal-Wallis tests will be used for continuous variables, and chi-square or Fisher's exact tests will be used for categorical variables. A p-value of < 0.05 will be considered statistically significant. For outcome variables with repeated measures at multiple time points (e.g., TNSS, inflammatory markers at weeks 0 and 12), a linear mixed-effects model (LMM) will be constructed to evaluate the effects of time, group, and their interaction, and to compare temporal trends between the intervention and control groups.

Conditions

Upper Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Yeast β-Glucan

Participants in the intervention group will take yeast β-glucan capsules daily. Each capsule contains 250 mg of yeast β-glucan, along with an appropriate amount of maltodextrin and silicon dioxide. All participants in the intervention group will take two capsules once daily, swallowed with warm water after meals.

Group Type: EXPERIMENTAL

yeast β-glucan

Intervention Type: DIETARY_SUPPLEMENT

Participants in the intervention group will take yeast β-glucan capsules daily. Each capsule contains 250 mg of yeast β-glucan, along with an appropriate amount of maltodextrin and silicon dioxide. All participants in the intervention group will take two capsules once daily, swallowed with warm water after meals.

placebo group

Participants in the placebo group will take two placebo capsules once daily in the same manner. The placebo capsules are identical to the intervention capsules in form, taste, appearance, and packaging, but contain only maltodextrin and a small amount of silicon dioxide.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

Participants in the placebo group will take two placebo capsules once daily in the same manner. The placebo capsules are identical to the intervention capsules in form, taste, appearance, and packaging, but contain only maltodextrin and a small amount of silicon dioxide.

Interventions

yeast β-glucan

Participants in the intervention group will take yeast β-glucan capsules daily. Each capsule contains 250 mg of yeast β-glucan, along with an appropriate amount of maltodextrin and silicon dioxide. All participants in the intervention group will take two capsules once daily, swallowed with warm water after meals.

Intervention Type: DIETARY_SUPPLEMENT

placebo

Participants in the placebo group will take two placebo capsules once daily in the same manner. The placebo capsules are identical to the intervention capsules in form, taste, appearance, and packaging, but contain only maltodextrin and a small amount of silicon dioxide.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Aged between 18 and 35 years;

2. Meeting the symptom criteria for persistent allergic rhinitis (AR) as defined in the Chinese Guidelines for Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition): (1) Symptoms: Two or more of the following-paroxysmal sneezing, watery rhinorrhea, nasal itching, and nasal congestion-lasting continuously or cumulatively for at least 1 hour per day; ocular symptoms such as tearing, itching, and redness may also be present; (2) Persistent AR: Symptoms occur on ≥4 days per week and persist for ≥4 consecutive weeks;

3. No use of probiotics, prebiotics, synbiotics, antihistamines, corticosteroids, or immunosuppressants within 1 month prior to screening;

4. Willing and able to maintain usual physical activity levels and dietary patterns during the study;

5. Able and willing to sign the informed consent form voluntarily.

Exclusion Criteria

1. Use of antibiotics, osmotic laxatives (e.g., magnesium sulfate, lactulose), anthraquinone-containing agents (e.g., rhubarb, aloe, senna), or gastrointestinal motility-promoting drugs (e.g., metoclopramide, domperidone, cisapride) within 1 month prior to screening;

2. Diagnosed with non-allergic rhinitis (e.g., vasomotor rhinitis, infectious rhinitis, hormonal rhinitis, drug-induced rhinitis), or with nasal polyps, severe nasal septum deviation, cerebrospinal fluid rhinorrhea, or aspirin-exacerbated respiratory disease (AERD);

3. Patients with uncontrolled allergic comorbidities, including sinusitis, otitis media, allergic asthma, or atopic dermatitis;

4. History of serious gastrointestinal diseases (e.g., severe diarrhea, inflammatory bowel disease), or gastrointestinal endoscopy within the past month;

5. Diagnosed with congenital genetic disorders, primary immunodeficiency diseases, severe systemic illnesses, or malignancies;

6. Influenza vaccination within the past 6 months;

7. Pregnant or lactating women, or women with plans to conceive during the study period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LanZhou University

OTHER

Sponsor Role: lead

Responsible Party

lixiaoqin

Associate Professor, School of Public Health, Lanzhou University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Public Health, Lanzhou University

Lanzhou, Gansu, China

Countries

China

Central Contacts

Xiaoqin Li, Dr.Prof.

Role: CONTACT

lixiaoqin@lzu.edu.cn

+86 15927366423

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

IRB25041502

Identifier Type: -

Identifier Source: org_study_id