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Ability of Beta-glucan Supplementation to Augment Immune Function

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ClinicalTrials.gov Identifier: NCT03769012
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
KGK Science Inc.
Information provided by (Responsible Party):
Kemin Foods LC

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

Condition or disease Intervention/treatment Phase
Cold Cold Symptom Flu Flu Symptom Supplement Stress Gastrointestinal Tolerance Dietary Supplement: Beta-Glucan Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-center, randomized, double-blind, placebo-controlled, parallel study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : July 30, 2019

Arm Intervention/treatment
Experimental: Treatment
Beta-Glucan
Dietary Supplement: Beta-Glucan
95% beta-glucan sourced from whole cell Euglena Gracilis

Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo
microcrystalline cellulose




Primary Outcome Measures :
  1. Global Cold/Flu Symptom Severity Score Wisconsin Upper Respiratory Symptom Survey (WURSS) [ Time Frame: ANOVA with 2 and 4 weeks post-marathon ]
    AUC for cold/flu symptoms from Wisconsin Upper Respiratory Symptom Score


Secondary Outcome Measures :
  1. URTI Cold/Flu Symptoms from Wisconsin Upper Respiratory Symptom Survey [ Time Frame: ANOVA with 2 and 4 weeks post-marathon ]
    Total number of symptoms

  2. Severity of cold/flu symptoms from Wisconsin Upper Respiratory Symptom Survey [ Time Frame: ANOVA with 2 and 4 weeks post-marathon ]
    Total severity score (each symptom scored on scale of 0-no symptom to 7-severe symptom)

  3. URTI Episodes from Wisconsin Upper Respiratory Symptom Survey [ Time Frame: ANOVA with 2 and 4 weeks post-marathon ]
    Total number of URTI Episodes/person

  4. Sick days [ Time Frame: ANOVA with 2 and 4 weeks post-marathon ]
    Total number of sick days/person

  5. Sick days [ Time Frame: ANOVA with 2 and 4 weeks post-marathon ]
    Percentage of subjects with sick days

  6. Stress Level from the perceived stress scale [ Time Frame: ANOVA with 2 and 4 weeks post-marathon ]
    Change from baseline on the Perceived Stress Scale

  7. C-Reactive Protein [ Time Frame: ANOVA with 2 and 4 weeks post-marathon ]
    Change in concentration from baseline

  8. Natural Killer Cell Activity [ Time Frame: ANOVA with 2 and 4 weeks post-marathon ]
    Change from baseline

  9. Gastrointestinal symptoms [ Time Frame: ANOVA with 2 and 4 weeks post-marathon ]
    Total gastrointestinal symptom rating score (GSRS)



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769012


Locations
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Canada, Ontario
KGK Science Inc. Recruiting
London, Ontario, Canada, N6A 5R8
Contact: Andrew Charrette    519-438-9374    acharrette@kgkscience.com   
Sponsors and Collaborators
Kemin Foods LC
KGK Science Inc.

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Responsible Party: Kemin Foods LC
ClinicalTrials.gov Identifier: NCT03769012     History of Changes
Other Study ID Numbers: 19BIHK
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No