Ability of Beta-glucan Supplementation to Augment Immune Function

NCT ID: NCT03769012

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-27
• Study Completion Date: 2020-05-30

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment

Beta-Glucan

Group Type: EXPERIMENTAL

Beta-Glucan

Intervention Type: DIETARY_SUPPLEMENT

95% beta-glucan sourced from whole cell Euglena Gracilis

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

microcrystalline cellulose

Interventions

Beta-Glucan

95% beta-glucan sourced from whole cell Euglena Gracilis

Intervention Type: DIETARY_SUPPLEMENT

Placebo

microcrystalline cellulose

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KGK Science Inc.

INDUSTRY

Sponsor Role: collaborator

Kemin Foods LC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

KGK Science Inc.

London, Ontario, Canada

Countries

Canada

Other Identifiers

19BIHK

Identifier Type: -

Identifier Source: org_study_id