Status:
COMPLETED
Ability of Beta-glucan Supplementation to Augment Immune Function
Lead Sponsor:
Kemin Foods LC
Collaborating Sponsors:
KGK Science Inc.
Conditions:
Cold
Cold Symptom
Eligibility:
All Genders
21-65 years
Phase:
NA
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 m...
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 p...
Eligibility Criteria
Inclusion
- Males and Females 21-65 years age
- Body Mass Index (BMI) \> 18 kg/m2 to \< 34.99 kg/m2
- Willing to wash-out for nutritional supplements known to affect immune function
- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
- Agree to keep lifestyle habits consistent
- Currently registered to participate in a full marathon and on a training regimen
- Healthy as determined by laboratory results, medical history, and physical exam
- Has given voluntary, written, informed consent to participate in the study
Exclusion
- Women who are pregnant, breastfeeding, or planning to become pregnant during the occurrence of the trial
- Verbal confirmation of previous major gastrointestinal surgery or other major digestive disorder which may interfere with the absorption of nutrients
- Participant has a known allergy to the test material's active or inactive ingredients
- Chronic consumption of beta-glucan supplements
- Consumption of anti-inflammatory medications known to affect immune function
- On antibiotics within 4 weeks of baseline
- Currently taking antipsychotic medications
- Prebiotics and probiotics unless on a stable regimen
- 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
- Verbal confirmation of a diagnosed chronic inflammatory condition
- Verbal confirmation of autoimmune disease or if immune-compromised
- Chronic recurring respiratory signs and symptoms due to allergies (including seasonal allergies) or chronic bronchitis, asthma, or wheezing
- Current or history (within past 6 months) of tobacco use
- Consumption of \>14 standard alcoholic drinks per week
Key Trial Info
Start Date :
December 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03769012
Start Date
December 27 2018
End Date
May 30 2020
Last Update
February 3 2021
Active Locations (1)
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1
KGK Science Inc.
London, Ontario, Canada, N6A 5R8