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:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT05431751
Eligibility Criteria:
Inclusion Criteria:
* Healthy adults
* Veins easy to see in both arms
* Willing to comply with a 24-hours wash-out period for vitamins and nutritional supplements
* Willing to comply with study procedures, including maintaining a consistent diet and lifestyle routine throughout the study. Consistent habit of bland breakfasts on days of clinic visits, abstaining from exercising, tobacco use, and nutritional supplements on the morning of a study visit, abstaining from use of coffee, tea, and soft-drinks for at least one hour prior to a clinic visit
* Willing to abstain from music, candy, gum, computer/cellphone use during clinic visits
Exclusion Criteria:
* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder)
* Taking anti-inflammatory medications on a daily basis (81 mg aspirin is acceptable)
* Vaccination during past 2 weeks
* Currently experiencing intense stressful events/ life changes
* Currently in intensive athletic training (such as marathon runners)
* Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel
* An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights)
* Unwilling to maintain a constant intake of supplements over the duration of the study
* Anxiety about having blood drawn
* People of childbearing potential: Pregnant, nursing, or trying to become pregnant
* Known food allergies or sensitivities related to the test product or placebo
* Prescription medication will be evaluated on a case-by-case basis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05431751
Study Brief:
Protocol Section:
NCT05431751