Explore Effects of Dietary Fish Oil in Human Skin

University of Michigan

Status and phase: Terminated; Phase 1

Conditions: Aging Problems

Treatments: Dietary Supplement: Fish Oil; Dietary Supplement: Soybean Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT03122912

HUM00113555 / Derm 683

Details and patient eligibility

About

The purpose of this study is to explore the potential differences in the skin of people who take fish oil versus soybean oil pills.

Enrollment: 17 patients

Sex: All

Ages: 50 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Fish Oil

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fish Oil

Soybean Oil

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Soybean Oil