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Explore Effects of Dietary Fish Oil in Human Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03122912
Recruitment Status : Suspended (Enrollment and interactions/interventions paused due to COVID-19. Expected to resume in the future. This is not a suspension of IRB approval)
First Posted : April 21, 2017
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Gary Fisher, 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.

Condition or disease Intervention/treatment Phase
Aging Problems Dietary Supplement: Fish Oil Dietary Supplement: Soybean Oil Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 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 : January 24, 2018
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122912


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Gary Fisher, PhD University of Michigan
Publications:

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Responsible Party: Gary Fisher, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03122912    
Other Study ID Numbers: HUM00113555 / Derm 683
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gary Fisher, University of Michigan:
fish oil