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:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT03643094
Eligibility Criteria:
Inclusion Criteria:
1. Adult people of either gender;
2. Age 40-75 years (inclusive);
3. BMI 25-34.9 (inclusive);
Exclusion Criteria:
1. Cancer during past 12 months;
2. Chemotherapy during past 12 months;
3. Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery is allowed, including previous removal of appendix and gall bladder);
4. Currently consuming large doses of anti-inflammatory nutritional supplements, and unwilling to stop taking these supplements for 2 weeks prior to and during the study;
5. Use of oral, inhaled or injected steroid medication within the last 6 months (for example: prednisone, dexamethasone). Nasal sprays for allergies are allowed;
6. Active uncontrolled auto-immune disease (for example: rheumatoid arthritis, lupus, inflammatory bowel disease, Celiac disease);
7. Currently experiencing intense stressful events or life changes;
8. Currently in intensive athletic training (such as marathon runners);
9. Women of childbearing potential, who are pregnant, nursing, or trying to become pregnant;
10. Known food allergies or sensitivities related to the test products or placebo;
11. History of drug abuse during past two years;
12. Participation in another clinical trial involving a consumable test product.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT03643094
Study Brief:
Protocol Section:
NCT03643094