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 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
NCT ID:
NCT03122912
Eligibility Criteria:
Inclusion Criteria:
* At least 50 years of age.
* Good general health.
* No disease states or physical conditions, which would impair evaluation of the biopsy sites.
* Signed, written and witnessed, Informed Consent Form
* BMI is between 18 to 36 kg/m2
Exclusion Criteria:
* Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol. A pregnant test will not be given to women who are capable to pregnant.
* Lovaza™ (prescription fish oil) and not willing to go off Lovaza for 3 weeks prior to enrollment to end of study.
* Frequent NSAID use (not including low dose aspirin) and not willing to go off NSAIDS for 3 weeks prior to enrollment and to end of study.
* Steroids (except inhaled steroids for asthma) and not willing to go off steroids for 3 weeks prior to enrollment to end of study.
* Other medications that may affect the biomarkers of interest.
* Any supplement use (i.e. fish oils, flax seed oils and other oils) that can affect the biomarkers of interest.
* Diet with frequent (1-2 days per week) oily fish (mackerel, salmon, sardines, cold water fish, et al).
* History of photosensitive conditions (connective tissue diseases, polymorphous light eruption, porphyrias etc).
* Received an experimental drug or used experimental device in the 30 days prior to admission to the study.
* History of keloids or any other condition that would complicate wound healing.
* Allergic to soybean, soybean oil, peanuts or seafood.
* History of allergic reactions to local anesthetics.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
99 Years
Study:
NCT03122912
Study Brief:
Protocol Section:
NCT03122912