Explore Effects of Dietary Fish Oil in Human Skin (NCT03122912) | Clinical Trial Compass
TerminatedPhase 1
Explore Effects of Dietary Fish Oil in Human Skin
Stopped: Enrollment and interactions/interventions paused due to COVID-19. Not expected to resume in the future. This is not a suspension of IRB approval
United States17 participantsStarted 2018-01-24
Plain-language summary
The purpose of this study is to explore the potential differences in the skin of people who take fish oil versus soybean oil pills.
Who can participate
Age range50 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Lovazaâ„¢ (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 reac…
What they're measuring
1
Change in barrier function improvement from Baseline to Week 16.
Timeframe: 16 weeks
2
Number of subjects with barrier function improvement from Baseline to Week 16.