NCT03518281

Ability of a Euglena Beta Glucan Supplementation to Augment Immune Function

A Single Center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Ability of a Euglena Beta Glucan Supplementation to Augment Immune Function in Endurance Athletes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Kemin Foods LC · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Upper respiratory tract infections cause cold and flu-like symptoms and are the most common form of acute illness. Certain populations are at increased risk of upper respiratory tract infections including athletes who train at a high level of intensity for prolonged periods of time. Consequently, some athletes experience higher rates of cold and flu-like symptoms than the general population. Euglena gracilis is a micro-algae which can synthesize many nutrients necessary for human health, including insoluble beta glucan. Thus, intake of whole cell Euglena may be beneficial to athletes by providing essential vitamins to optimize immune function.

Detailed description

At screening, an informed consent form will be given to the potential volunteer. They will be required to read the information and 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. Screening assessments include: 1. Review of medical history, concomitant therapies and current health status (weight, height, BMI, vital signs, safety blood work) 2. Assesses inclusion and exclusion criteria 3. Urine pregnancy test for female potential participants that are not post-menopausal Eligible participants will return to the clinic for baseline assessments. Baseline (day 0) assessments include: 1. Review of concomitant therapies and current health status 2. Review pre-supplement emergent AEs 3. Reassess inclusion and exclusion criteria 4. Randomization of eligible participants 5. Dispense daily upper respiratory tract symptom questionnaire 6. Collect saliva sample for measurement of secretory IgA 7. Collect blood sample for the analysis of cell activity 8. Administer mood and stress questionnaire in-clinic 9. Dispense daily gastrointestinal and bowel questionnaire 10. Dispense investigational product and instruct participants on use 11. Dispense daily study diary At the end-of-study visit (Day 90) participants will return to the clinic for Visit 3 assessments with unused investigational product, completed study diaries, daily symptom questionnaires, daily gastrointestinal and bowel diaries. Visit 3 assessments include: 1. Collection of all study diaries 2. Return of unused investigational product and calculate compliance 3. Review of concomitant therapies and adverse events 4. Check of health status (vitals, BMI, safety bloodwork) 5. Administer mood and stress questionnaire in-clinic. 6. Collect saliva sample for an end-of-study measurement of secretory IgA 7. Complete Product Tolerability and Perception Questionnaire

Conditions

• Symptoms Flu
• Symptoms Cold

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Whole Cell Euglena containing Beta Glucan	Whole Cell Euglena containing \>50% Beta Glucan
DIETARY_SUPPLEMENT	Placebo	microcrystalline cellulose, hypromellose, titanium dioxide, water

Timeline

• Start date: 2018-03-28
• Primary completion: 2018-09-01
• Completion: 2018-12-01
• First posted: 2018-05-08
• Last updated: 2018-12-05

Locations

1 site across 1 country: Canada