Explore Effects of Dietary Fish Oil in Human Skin
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in barrier function improvement from Baseline to Week 16.
研究概览
简要总结
The purpose of this study is to explore the potential differences in the skin of people who take fish oil versus soybean oil pills.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Soybean Oil
Dosage will be 3000 mg of soybean oil taken orally daily for up to 16 weeks.
干预措施: Soybean Oil (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.
干预措施: Fish Oil (Dietary Supplement)
结局指标
主要结局
Change in barrier function improvement from Baseline to Week 16.
时间窗: 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.
时间窗: 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.
次要结局
- Change in Omega-3 Fatty Acid Levels in blood from Baseline to Week 16.(16 weeks)
- Number of subjects with increased Omega-3 Fatty Acid Levels in Blood from Baseline to Week 16.(16 weeks)
研究者
Gary Fisher
Professor
University of Michigan