Ability of Beta-glucan Supplementation to Augment Immune Function

Study Overview
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Brief Summary
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This proposed study is designed to assess the efficacy of a capsule containing beta-glucan taken orally daily as compared to a placebo capsule on the URTI symptoms, and the immune response change in marathon runners

Detailed Description
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At screening, an informed consent form will be given to the potential volunteer. They will be required to read the information and will be given the opportunity to seek more information if needed or provided with the option of taking the consent form home to review prior to making their decision. If agreeable, the volunteer will sign the consent form and receive a duplicate of the signed copy. Once consent has been obtained, the screening visit will proceed. Each volunteer will be sequentially assigned a screening number to be entered in the screening and enrollment log. Screening assessments include: review medical history, assess inclusion and exclusion criteria, vitals, study diary, URTI symptom questionnaire, bowel diary, and GI symptom questionnaire. The next visit will be scheduled 14 days prior to their marathon date (baseline). Participants will be reminded to complete URTI questionnaire, daily study diary, modified GI symptoms and bowel diary in advance of this baseline visit. At baseline participants will begin daily completion of study diaries, URTI questionnaires, daily bowel diaries, and GI tolerance questionnaires. In clinic subjects will complete mood and stress questionnaires, and blood sample for the analysis of CRP and NK cell activity. In addition, on the day of the marathon the participant will be instructed to complete a muscle soreness assessment. Two and four weeks post-marathon participants will return to the clinic for with unused investigational product, completed study diaries, daily URTI questionnaires, daily bowel diaries, and GI tolerance questionnaires. In clinic subjects will complete mood and stress questionnaires, and blood sample for the analysis of CRP and NK cell activity.

Official Title
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A Single-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Ability of Beta-glucan (to Augment Immune Function, Decrease URTI Incidence Rates, and Counter Immune Changes in Marathon Runners

Conditions
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Cold, Cold Symptom, Flu, Flu Symptom, Supplement, Stress, Gastrointestinal Tolerance

Intervention / Treatment
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* Dietary Supplement: Beta-Glucan
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and Females 21-65 years age Body Mass Index (BMI) > 18 kg/m2 to < 34.99 kg/m2 Willing to wash-out for nutritional supplements known to affect immune function Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Agree to keep lifestyle habits consistent Currently registered to participate in a full marathon and on a training regimen Healthy as determined by laboratory results, medical history, and physical exam Has given voluntary, written, informed consent to participate in the study Exclusion Criteria: Women who are pregnant, breastfeeding, or planning to become pregnant during the occurrence of the trial Verbal confirmation of previous major gastrointestinal surgery or other major digestive disorder which may interfere with the absorption of nutrients Participant has a known allergy to the test material's active or inactive ingredients Chronic consumption of beta-glucan supplements Consumption of anti-inflammatory medications known to affect immune function On antibiotics within 4 weeks of baseline Currently taking antipsychotic medications Prebiotics and probiotics unless on a stable regimen Verbal confirmation of Type I or Type II diabetes or clinically important renal, hepatic, cardiac, pulmonary, pancreatic, neurologic, or biliary disorder, or cancer to be assessed by QI Verbal confirmation of a diagnosed chronic inflammatory condition Verbal confirmation of autoimmune disease or if immune-compromised Chronic recurring respiratory signs and symptoms due to allergies (including seasonal allergies) or chronic bronchitis, asthma, or wheezing Current or history (within past 6 months) of tobacco use Consumption of >14 standard alcoholic drinks per week

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center, randomized, double-blind, placebo-controlled, parallel study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Beta-Glucan | Dietary Supplement: Beta-Glucan<br>* 95% beta-glucan sourced from whole cell Euglena Gracilis<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* microcrystalline cellulose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Cold/Flu Symptom Severity Score Wisconsin Upper Respiratory Symptom Survey (WURSS) | AUC for cold/flu symptoms from Wisconsin Upper Respiratory Symptom Score | ANOVA with 2 and 4 weeks post-marathon | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| URTI Cold/Flu Symptoms from Wisconsin Upper Respiratory Symptom Survey | Total number of symptoms | ANOVA with 2 and 4 weeks post-marathon | 
| Severity of cold/flu symptoms from Wisconsin Upper Respiratory Symptom Survey | Total severity score (each symptom scored on scale of 0-no symptom to 7-severe symptom) | ANOVA with 2 and 4 weeks post-marathon | 
| URTI Episodes from Wisconsin Upper Respiratory Symptom Survey | Total number of URTI Episodes/person | ANOVA with 2 and 4 weeks post-marathon | 
| Sick days | Total number of sick days/person | ANOVA with 2 and 4 weeks post-marathon | 
| Sick days | Percentage of subjects with sick days | ANOVA with 2 and 4 weeks post-marathon | 
| Stress Level from the perceived stress scale | Change from baseline on the Perceived Stress Scale | ANOVA with 2 and 4 weeks post-marathon | 
| C-Reactive Protein | Change in concentration from baseline | ANOVA with 2 and 4 weeks post-marathon | 
| Natural Killer Cell Activity | Change from baseline | ANOVA with 2 and 4 weeks post-marathon | 
| Gastrointestinal symptoms | Total gastrointestinal symptom rating score (GSRS) | ANOVA with 2 and 4 weeks post-marathon |