Aging ProblemsPhase 1NCT03122912
Explore Effects of Dietary Fish Oil in Human Skin
A Phase 1 study testing Fish Oil and Soybean Oil in people with Aging Problems, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging Problems
- What is being tested?
- Fish Oil and Soybean Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2018to 1 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to explore the potential differences in the skin of people who take fish oil versus soybean oil pills.
- Conditions
- Aging Problems
- Being tested
- Fish Oil, Soybean Oil
- Keywords
- fish oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
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 OilDietary supplement
Dosage will be 3000 mg of soybean oil taken orally daily for up to 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fish Oil | Experimental | 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. Receives: Dietary Supplement: Fish Oil |
| Soybean Oil | Active comparator | Dosage will be 3000 mg of soybean oil taken orally daily for up to 16 weeks. Receives: Dietary Supplement: Soybean Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in barrier function improvement from Baseline to Week 16.
Barrier function will be measured at baseline and 16 weeks. Differences in barrier function between the two visits will be assessed.
Measured: 16 weeks
Number of subjects with barrier function improvement from Baseline to Week 16.
Barrier function will be measured at baseline and 16 weeks. The number of subjects with dichotomized improvement in barrier function between the two visits will be compared.
Measured: 16 weeks
Secondary outcomes (2)
Change in Omega-3 Fatty Acid Levels in blood from Baseline to Week 16.
Omega-3 fatty acids in blood will be measured at baseline and 16 weeks. Differences in levels between the two visits will be assessed.
Measured: 16 weeks
Number of subjects with increased Omega-3 Fatty Acid Levels in Blood from Baseline to Week 16.
Omega-3 fatty acids in blood will be measured at baseline and 16 weeks. The number of subjects with dichotomized improvement in levels between the two visits will be compared.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start24 Jan 2018
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Aging ProblemsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Fisher, University of Michigan
- Investigators
- Gary Fisher, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122912
- Sponsor's protocol ID
- HUM00113555 / Derm 683
- Status last verified
- Apr 2021
- First submitted
- 18 Apr 2017
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Black HS, Rhodes LE. Potential Benefits of Omega-3 Fatty Acids in Non-Melanoma Skin Cancer. J Clin Med. 2016 Feb 4;5(2):23. doi: 10.3390/jcm5020023.
PubMed 26861407Millsop JW, Bhatia BK, Debbaneh M, Koo J, Liao W. Diet and psoriasis, part III: role of nutritional supplements. J Am Acad Dermatol. 2014 Sep;71(3):561-9. doi: 10.1016/j.jaad.2014.03.016. Epub 2014 Apr 26.
PubMed 24780177Pilkington SM, Rhodes LE, Al-Aasswad NM, Massey KA, Nicolaou A. Impact of EPA ingestion on COX- and LOX-mediated eicosanoid synthesis in skin with and without a pro-inflammatory UVR challenge--report of a randomised controlled study in humans. Mol Nutr Food Res. 2014 Mar;58(3):580-90. doi: 10.1002/mnfr.201300405. Epub 2013 Dec 5.
PubMed 24311515Rhodes LE, Shahbakhti H, Azurdia RM, Moison RM, Steenwinkel MJ, Homburg MI, Dean MP, McArdle F, Beijersbergen van Henegouwen GM, Epe B, Vink AA. Effect of eicosapentaenoic acid, an omega-3 polyunsaturated fatty acid, on UVR-related cancer risk in humans. An assessment of early genotoxic markers. Carcinogenesis. 2003 May;24(5):919-25. doi: 10.1093/carcin/bgg038.
PubMed 12771037Rhodes LE, Durham BH, Fraser WD, Friedmann PS. Dietary fish oil reduces basal and ultraviolet B-generated PGE2 levels in skin and increases the threshold to provocation of polymorphic light eruption. J Invest Dermatol. 1995 Oct;105(4):532-5. doi: 10.1111/1523-1747.ep12323389.
PubMed 7561154Rhodes LE, O'Farrell S, Jackson MJ, Friedmann PS. Dietary fish-oil supplementation in humans reduces UVB-erythemal sensitivity but increases epidermal lipid peroxidation. J Invest Dermatol. 1994 Aug;103(2):151-4. doi: 10.1111/1523-1747.ep12392604.
PubMed 8040603Vargas ML, Almario RU, Buchan W, Kim K, Karakas SE. Metabolic and endocrine effects of long-chain versus essential omega-3 polyunsaturated fatty acids in polycystic ovary syndrome. Metabolism. 2011 Dec;60(12):1711-8. doi: 10.1016/j.metabol.2011.04.007. Epub 2011 Jun 2.
PubMed 21640360Shinto L, Marracci G, Mohr DC, Bumgarner L, Murchison C, Senders A, Bourdette D. Omega-3 Fatty Acids for Depression in Multiple Sclerosis: A Randomized Pilot Study. PLoS One. 2016 Jan 22;11(1):e0147195. doi: 10.1371/journal.pone.0147195. eCollection 2016.
PubMed 26799942Tecklenburg-Lund S, Mickleborough TD, Turner LA, Fly AD, Stager JM, Montgomery GS. Randomized controlled trial of fish oil and montelukast and their combination on airway inflammation and hyperpnea-induced bronchoconstriction. PLoS One. 2010 Oct 18;5(10):e13487. doi: 10.1371/journal.pone.0013487.
PubMed 20976161Mozurkewich EL, Clinton CM, Chilimigras JL, Hamilton SE, Allbaugh LJ, Berman DR, Marcus SM, Romero VC, Treadwell MC, Keeton KL, Vahratian AM, Schrader RM, Ren J, Djuric Z. The Mothers, Omega-3, and Mental Health Study: a double-blind, randomized controlled trial. Am J Obstet Gynecol. 2013 Apr;208(4):313.e1-9. doi: 10.1016/j.ajog.2013.01.038.
PubMed 23531328Flock MR, Skulas-Ray AC, Harris WS, Gaugler TL, Fleming JA, Kris-Etherton PM. Effects of supplemental long-chain omega-3 fatty acids and erythrocyte membrane fatty acid content on circulating inflammatory markers in a randomized controlled trial of healthy adults. Prostaglandins Leukot Essent Fatty Acids. 2014 Oct;91(4):161-8. doi: 10.1016/j.plefa.2014.07.006. Epub 2014 Jul 17.
PubMed 25091379
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore Effects of Dietary Fish Oil in Human Skin
- ClinicalTrials.gov ID
- NCT03122912
- Acronym / sponsor ID
- HUM00113555 / Derm 683
- Conditions
- Aging Problems
- Keywords
- fish oil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the potential differences in the skin of people who take fish oil versus soybean oil pills.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish Oil | Experimental | Dietary Supplement: Fish OilCapsules 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 OilDosage will be 3000 mg of soybean oil taken orally daily for up to 16 weeks. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish OilCapsules 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. | Dietary supplement | Fish Oil |
| Soybean OilDosage will be 3000 mg of soybean oil taken orally daily for up to 16 weeks. | Dietary supplement | Soybean Oil |
Primary outcome
Change in barrier function improvement from Baseline to Week 16.
Time frame: 16 weeks
Barrier function will be measured at baseline and 16 weeks. Differences in barrier function between the two visits will be assessed.
Number of subjects with barrier function improvement from Baseline to Week 16.
Time frame: 16 weeks
Barrier function will be measured at baseline and 16 weeks. The number of subjects with dichotomized improvement in barrier function between the two visits will be compared.
2 secondary outcomes
Change in Omega-3 Fatty Acid Levels in blood from Baseline to Week 16.
Time frame: 16 weeks
Number of subjects with increased Omega-3 Fatty Acid Levels in Blood from Baseline to Week 16.
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Enrollment and interactions/interventions paused due to COVID-19. Not expected to resume in the future. This is not a suspension of IRB approval). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Background: PubMed 26861407Black HS, Rhodes LE. Potential Benefits of Omega-3 Fatty Acids in Non-Melanoma Skin Cancer. J Clin Med. 2016 Feb 4;5(2):23. doi: 10.3390/jcm5020023.
- Background: PubMed 24780177Millsop JW, Bhatia BK, Debbaneh M, Koo J, Liao W. Diet and psoriasis, part III: role of nutritional supplements. J Am Acad Dermatol. 2014 Sep;71(3):561-9. doi: 10.1016/j.jaad.2014.03.016. Epub 2014 Apr 26.
- Background: PubMed 24311515Pilkington SM, Rhodes LE, Al-Aasswad NM, Massey KA, Nicolaou A. Impact of EPA ingestion on COX- and LOX-mediated eicosanoid synthesis in skin with and without a pro-inflammatory UVR challenge--report of a randomised controlled study in humans. Mol Nutr Food Res. 2014 Mar;58(3):580-90. doi: 10.1002/mnfr.201300405. Epub 2013 Dec 5.
- Background: PubMed 12771037Rhodes LE, Shahbakhti H, Azurdia RM, Moison RM, Steenwinkel MJ, Homburg MI, Dean MP, McArdle F, Beijersbergen van Henegouwen GM, Epe B, Vink AA. Effect of eicosapentaenoic acid, an omega-3 polyunsaturated fatty acid, on UVR-related cancer risk in humans. An assessment of early genotoxic markers. Carcinogenesis. 2003 May;24(5):919-25. doi: 10.1093/carcin/bgg038.
- Background: PubMed 7561154Rhodes LE, Durham BH, Fraser WD, Friedmann PS. Dietary fish oil reduces basal and ultraviolet B-generated PGE2 levels in skin and increases the threshold to provocation of polymorphic light eruption. J Invest Dermatol. 1995 Oct;105(4):532-5. doi: 10.1111/1523-1747.ep12323389.
- Background: PubMed 8040603Rhodes LE, O'Farrell S, Jackson MJ, Friedmann PS. Dietary fish-oil supplementation in humans reduces UVB-erythemal sensitivity but increases epidermal lipid peroxidation. J Invest Dermatol. 1994 Aug;103(2):151-4. doi: 10.1111/1523-1747.ep12392604.
- Background: PubMed 21640360Vargas ML, Almario RU, Buchan W, Kim K, Karakas SE. Metabolic and endocrine effects of long-chain versus essential omega-3 polyunsaturated fatty acids in polycystic ovary syndrome. Metabolism. 2011 Dec;60(12):1711-8. doi: 10.1016/j.metabol.2011.04.007. Epub 2011 Jun 2.
- Background: PubMed 26799942Shinto L, Marracci G, Mohr DC, Bumgarner L, Murchison C, Senders A, Bourdette D. Omega-3 Fatty Acids for Depression in Multiple Sclerosis: A Randomized Pilot Study. PLoS One. 2016 Jan 22;11(1):e0147195. doi: 10.1371/journal.pone.0147195. eCollection 2016.
- Background: PubMed 20976161Tecklenburg-Lund S, Mickleborough TD, Turner LA, Fly AD, Stager JM, Montgomery GS. Randomized controlled trial of fish oil and montelukast and their combination on airway inflammation and hyperpnea-induced bronchoconstriction. PLoS One. 2010 Oct 18;5(10):e13487. doi: 10.1371/journal.pone.0013487.
- Background: PubMed 23531328Mozurkewich EL, Clinton CM, Chilimigras JL, Hamilton SE, Allbaugh LJ, Berman DR, Marcus SM, Romero VC, Treadwell MC, Keeton KL, Vahratian AM, Schrader RM, Ren J, Djuric Z. The Mothers, Omega-3, and Mental Health Study: a double-blind, randomized controlled trial. Am J Obstet Gynecol. 2013 Apr;208(4):313.e1-9. doi: 10.1016/j.ajog.2013.01.038.
- Background: PubMed 25091379Flock MR, Skulas-Ray AC, Harris WS, Gaugler TL, Fleming JA, Kris-Etherton PM. Effects of supplemental long-chain omega-3 fatty acids and erythrocyte membrane fatty acid content on circulating inflammatory markers in a randomized controlled trial of healthy adults. Prostaglandins Leukot Essent Fatty Acids. 2014 Oct;91(4):161-8. doi: 10.1016/j.plefa.2014.07.006. Epub 2014 Jul 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Fisher, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fish Oil and Soybean Oil in people with Aging Problems, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment and interactions/interventions paused due to COVID-19. Not expected to resume in the future. This is not a suspension of IRB approval). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in barrier function improvement from Baseline to Week 16. (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03122912, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.