Explore Effects of Dietary Fish Oil in Human Skin

Phase 1

Terminated

• Conditions: Aging Problems
• Interventions: Dietary Supplement: Soybean Oil; Dietary Supplement: Fish Oil

• Registration Number: NCT03122912
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-21
• Study Start: 2018-01-24
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Soybean Oil	Soybean Oil	Dosage will be 3000 mg of soybean oil taken orally daily for up to 16 weeks.
Fish Oil	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.

Primary Outcome Measures

Name	Time	Method
Change in barrier function improvement from Baseline to Week 16.	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.	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.

Secondary Outcome Measures

Name	Time	Method
Change in Omega-3 Fatty Acid Levels in blood from Baseline to Week 16.	16 weeks	Omega-3 fatty acids in blood will be measured at baseline and 16 weeks. Differences in levels between the two visits will be assessed.
Number of subjects with increased Omega-3 Fatty Acid Levels in Blood from Baseline to Week 16.	16 weeks	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States