Explore Effects of Dietary Fish Oil in Human Skin

Aging Problems Clinical Trial

Official title:

Explore Effects of Dietary Fish Oil in Human Skin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03122912
• Other study ID #: HUM00113555 / Derm 683
• Status: Terminated
• Phase: Phase 1
• Start date: January 24, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: April 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging Problems

Intervention

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
Dosage will be 3000 mg of soybean oil taken orally daily for up to 16 weeks.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (11)

Black HS, Rhodes LE. Potential Benefits of Omega-3 Fatty Acids in Non-Melanoma Skin Cancer. J Clin Med. 2016 Feb 4;5(2). pii: E23. doi: 10.3390/jcm5020023. Review. — View Citation

Flock 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. — View Citation

Millsop 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. Review. — View Citation

Mozurkewich 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. — View Citation

Pilkington 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. — View Citation

Rhodes 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. — View Citation

Rhodes 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. — View Citation

Rhodes 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. — View Citation

Shinto 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. — View Citation

Tecklenburg-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. — View Citation

Vargas 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 weeks
Primary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks