Ability of Beta-glucan Supplementation to Augment Immune Function

NCT03769012 | Completed

• 1 other identifier: 19BIHK
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cold; Cold Symptom; Flu; Flu Symptom; Supplement; Stress; Gastrointestinal Tolerance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• URTI Cold/Flu Symptoms from Wisconsin Upper Respiratory Symptom Survey

  ANOVA with 2 and 4 weeks post-marathon

• Severity of cold/flu symptoms from Wisconsin Upper Respiratory Symptom Survey

  ANOVA with 2 and 4 weeks post-marathon

• URTI Episodes from Wisconsin Upper Respiratory Symptom Survey

  ANOVA with 2 and 4 weeks post-marathon

• Sick days

  ANOVA with 2 and 4 weeks post-marathon

• Sick days

  ANOVA with 2 and 4 weeks post-marathon

Study Arms (2)

Treatment

EXPERIMENTAL

Beta-Glucan

Dietary Supplement: Beta-Glucan

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Beta-Glucan DIETARY_SUPPLEMENT

95% beta-glucan sourced from whole cell Euglena Gracilis

Treatment

Placebo DIETARY_SUPPLEMENT

microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kemin Foods LC: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Conditions

Common Cold; Influenza, Human

Interventions

beta-Glucans

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A randomization schedule will be created and provided to the Investigator indicating the order of randomization. Each participant will be assigned a randomization code according to the order of the randomization list generated using www.randomization.com. Enrolled participants will be randomized to the different treatment arms at day -14. Concealment of the allocation of treatment will be employed through the use of opaque sealed envelopes, each labeled with a randomization number. Each envelope will contain information regarding the treatment associated with each randomization number.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, randomized, double-blind, placebo-controlled, parallel study

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 7, 2018
• Study Start: December 27, 2018
• Primary Completion: November 30, 2019
• Study Completion: May 30, 2020
• Last Updated: February 3, 2021

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)