Explore Effects of Dietary Fish Oil in Human Skin

April 30, 2021 updated by: Gary Fisher, University of Michigan
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: Soybean Oil
Dosage will be 3000 mg of soybean oil taken orally daily for up to 16 weeks.
Dietary supplement: Soybean Oil
Dosage will be 3000 mg of soybean oil taken orally daily for up to 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks
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.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Omega-3 Fatty Acid Levels in blood from Baseline to Week 16.
Time Frame: 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.
16 weeks
Number of subjects with increased Omega-3 Fatty Acid Levels in Blood from Baseline to Week 16.
Time Frame: 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.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2018

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

April 18, 2017

First Submitted That Met QC Criteria

April 18, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUM00113555 / Derm 683

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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