Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT03769012
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT03769012
Study Brief:
Protocol Section:
NCT03769012