A Randomized, Double-blinded Nutritional Study to Determine the Effect of a Concentrated Cetoleic Acid Fish Oil on Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- POEM
研究概览
简要总结
Atopic Dermatitis is associated with pronounced changes in the lipid composition in the skin. The lipid changes are influenced by and contributing to both the inflammatory circuit and the impaired barrier as well as changes in the skin microbiome This nutritional study will investigate the effect of long-chain monounsaturated fatty acid Cetoleic acid on atoptic dermatitis. Earlier studies have shown a anti-inflammatory effect of celoteic acid.
详细描述
Women and men will be recruited to a placebo or a cetoleic-rich fish oil group and be examined for the effect on atopic dermatitis before, during and after the study period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Interventions are given as 1g bovine capsules of equal size, weight and appearance, and provided in identical bottles with a coded label.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men 18-80 years of age.
- •Diagnosed with active mild to moderate atopic dermatitis with an EASI of 1.1- 21.
- •Willing to refrain from oil supplements (omega-3, borage, evening primrose, etc.) for 1 month before study begin (washout) and during the study
- •Willing to take the study supplement for 6 months
排除标准
- •Known allergy to fish products
- •Subjects known to be pregnant or breast feeding
- •Subjects perceiving systemically administered medication for AD (other than topical)
- •Subjects with auto-immune diseases (except asthma and seasonal/perennial rhinitis)
- •Subjects with a diagnosis of other skin diseases
结局指标
主要结局
POEM
时间窗: 6 months
Change in POEM (Patient Oriented Eczema Measure)
EASI
时间窗: 6 months
Change in EASI (Eczema Area and Serverity Index) POEM).
DQLI
时间窗: 6 months
Change in DQLI
Itch Numerical Rating Scale (NRS)
时间窗: 6 months
Change in experienced itch on average the last 24 hours, and how the worst itch in the past 24 hours was. Scale from 0 (no itch) to 10 (worst imaginable itch).
次要结局
- Lipid compositions in skin(6 months)
- Inflammation in skin(6 months)
- TEWL(6 months)
- Blood lipids(6 months)
- Cetoleic acid with EASI parameters(6 months)
- Omega-3 index with EASI parameters(6 months)
- Fatty acid composition in red blood cells(6 months)
- Hydroxylated omega-3 fatty acids in plasma(6 months)