Explore Effects of Dietary Fish Oil in Human Skin

Sponsor
University of Michigan (Other)
Overall Status
Terminated
CT.gov ID
NCT03122912
Collaborator
(none)
17
1
2
36.3
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Fish Oil
  • Dietary Supplement: Soybean Oil
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Explore Effects of Dietary Fish Oil in Human Skin
Actual Study Start Date :
Jan 24, 2018
Actual Primary Completion Date :
Feb 1, 2021
Actual Study Completion Date :
Feb 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan

Investigators

  • Principal Investigator: Gary Fisher, PhD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Gary Fisher, Professor, University of Michigan
ClinicalTrials.gov Identifier:
NCT03122912
Other Study ID Numbers:
  • HUM00113555 / Derm 683
First Posted:
Apr 21, 2017
Last Update Posted:
May 6, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gary Fisher, Professor, University of Michigan

Study Results

No Results Posted as of May 6, 2021