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 range

50 Years – 99 Years

Sex

ALL

See this in plain English?

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. * 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 reac…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in barrier function improvement from Baseline to Week 16.

Timeframe: 16 weeks

Number of subjects with barrier function improvement from Baseline to Week 16.

Timeframe: 16 weeks

Trial details

NCT IDNCT03122912

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-01

View on ClinicalTrials.gov More Aging Problems trials

Who can participate

Age range

50 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.