NCT03769012

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Kemin Foods LC · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Cold
• Cold Symptom
• Flu
• Flu Symptom
• Supplement
• Stress
• Gastrointestinal Tolerance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Beta-Glucan	95% beta-glucan sourced from whole cell Euglena Gracilis
DIETARY_SUPPLEMENT	Placebo	microcrystalline cellulose

Timeline

• Start date: 2018-12-27
• Primary completion: 2019-11-30
• Completion: 2020-05-30
• First posted: 2018-12-07
• Last updated: 2021-02-03

Locations

1 site across 1 country: Canada