Ability of Beta-glucan Supplementation to Augment Immune Function

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

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

Study Overview

• Status: Completed
• Conditions: Stress; Flu; Cold; Flu Symptom; Cold Symptom; Gastrointestinal Tolerance; Supplement
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Beta-Glucan

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Science Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males and Females 21-65 years age
2. Body Mass Index (BMI) > 18 kg/m2 to < 34.99 kg/m2
3. Willing to wash-out for nutritional supplements known to affect immune function
4. Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
5. Agree to keep lifestyle habits consistent
6. Currently registered to participate in a full marathon and on a training regimen
7. Healthy as determined by laboratory results, medical history, and physical exam
8. Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

1. Women who are pregnant, breastfeeding, or planning to become pregnant during the occurrence of the trial
2. Verbal confirmation of previous major gastrointestinal surgery or other major digestive disorder which may interfere with the absorption of nutrients
3. Participant has a known allergy to the test material's active or inactive ingredients
4. Chronic consumption of beta-glucan supplements
5. Consumption of anti-inflammatory medications known to affect immune function
6. On antibiotics within 4 weeks of baseline
7. Currently taking antipsychotic medications
8. Prebiotics and probiotics unless on a stable regimen
9. 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
10. Verbal confirmation of a diagnosed chronic inflammatory condition
11. Verbal confirmation of autoimmune disease or if immune-compromised
12. Chronic recurring respiratory signs and symptoms due to allergies (including seasonal allergies) or chronic bronchitis, asthma, or wheezing
13. Current or history (within past 6 months) of tobacco use
14. Consumption of >14 standard alcoholic drinks per week

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Dietary supplement: Placebo; microcrystalline cellulose
EXPERIMENTAL: Treatment; Beta-Glucan	Dietary supplement: Beta-Glucan; 95% beta-glucan sourced from whole cell Euglena Gracilis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kemin Foods LC
• Collaborators: KGK Science Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 27, 2018
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): May 30, 2020

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (ACTUAL): December 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 19BIHK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No