| Registry | NCT03122912 |
|---|---|
| Status | Terminated - Enrollment and interactions/interventions paused due to COVID-19. Not expected to resume in the future. This is not a suspension of IRB approval |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: none, basic science |
| Enrollment | 17 (Actual) |
| Sponsor | University of Michigan (Other) |
| Conditions | Aging Problems |
| Interventions | Fish Oil, Soybean Oil (Dietary supplement) |
| Dates | start 2018-01-24, primary completion 2021-02-01, completion 2021-02-01, first posted 2017-04-21, last updated 2021-05-06 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Aging Problems All trials of Fish Oil All trials of Soybean Oil
The purpose of this study is to explore the potential differences in the skin of people who take fish oil versus soybean oil pills.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Fish Oil | Experimental | Dietary Supplement: Fish Oil | Capsules contain omega-3 fatty acids (fish oil). Dosage of 3180 mg of omega-3 fatty acids will be taken orally daily up to 16 weeks. |
| Soybean Oil | Active comparator | Dietary Supplement: Soybean Oil | Dosage will be 3000 mg of soybean oil taken orally daily for up to 16 weeks. |
Sex: All, ages: 50 Years to 99 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| University of Michigan | Ann Arbor, Michigan | United States |