The Effect of Omega-3 Polyunsaturated Fatty Acids on UV-induced Immunosuppression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Degree of suppression of nickel-induced contact hypersensitivity
研究概览
简要总结
Skin cancer incidence continues to rise and ultraviolet radiation (UVR) in sunlight is the principal cause. Solar UVR can promote cancer development through its ability to suppress the immune system. The purpose of this study is to determine whether dietary supplementation with omega-3 polyunsaturated fatty acids can protect human skin from UVR-induced immunosuppression.
详细描述
Skin cancer is one of the most common human cancers with a rising incidence and considerable negative impact on human health. Exposure to ultraviolet radiation (UVR) in sunlight is the major aetiological factor in skin cancer initiation and progression. Human case-control studies have reported an inverse relationship between dietary fish or omega-3 polyunsaturated fatty acid (PUFA) intake and occurrence of non-melanoma skin cancer. Omega-3 PUFA have the potential to reduce the risk of photocarcinogenesis primarily by their ability to reduce production of prostaglandin E2 and consequently photoimmunosuppression. To date, no studies have assessed the impact of omega-3 PUFA on skin photoimmunosuppression in humans.
OBJECTIVE
To examine the potential of dietary omega-3 PUFA to protect against UVR-induced cutaneous immunosuppression in humans.
STUDY DESIGN: A double-blind randomised controlled nutritional study in 64 healthy human volunteers with nickel sensitivity. Volunteers will receive 3 months dietary supplementation with either omega-3 PUFA (n=32) or gelatine (n=32) both provided in identical gelatine capsules.
The aim is to quantify the influence of omega-3 PUFA on:
- UVR-induced suppression of clinical contact hypersensitivity (CHS) responses
- UVR-induced modulation of epidermal Langerhans cell trafficking
- UVR-induced modulation of levels of immunoregulatory mediators
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pre-menopausal females
- •Sun-reactive skin type I / II
- •Reporting allergy to jewellery with nickel content
排除标准
- •History of atopy
- •History of skin cancer
- •History of a photosensitivity disorder
- •Sunbathing (including sunbeds) in the last 3 months
- •Pregnancy
- •History of cardiac disease
- •Taking photoactive medicine
- •Not able to eat fish or gelatine
- •Taking fish oil supplements prior to the study
结局指标
主要结局
Degree of suppression of nickel-induced contact hypersensitivity
时间窗: 3 months
Measurement of the erythema of nickel-induced eczema using a reflectance instrument
次要结局
- Intergroup comparison of cytokine and eicosanoid levels and Langerhans cell numbers(3 months)
- Correlation of susceptibility to photoimmunosuppression in all subjects with their erythrocyte omega-3:omega-6 PUFA ratio(3 months)
- Correlation of susceptibility to photoimmunosuppression with cytokine and eicosanoid levels and Langerhans cell numbers(3 months)
研究者
Lesley Rhodes
Professor of Experimental Dermatology
University of Manchester