Ability of a Euglena Beta Glucan Supplementation to Augment Immune Function
Condition: Symptoms Flu; Symptoms Cold
Study type: Interventional

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
    

Intervention name(s): Whole Cell Euglena containing Beta Glucan; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Whole Cell Euglena containing >50% Beta Glucan; microcrystalline cellulose, hypromellose, titanium dioxide, water
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention