Impact of Nutrients-fortified Egg Consumption on Eczema Condition in Individuals With Eczema
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in eczema severity using the SCORing Atopic Dermatitis (SCORAD) index
研究概览
简要总结
The study aims to assess the effects of daily consumption of nutrients-fortified eggs on eczema condition in individuals with eczema.
It is hypothesised that daily consumption of nutrients-fortified egg, which is rich in antioxidants, will improve eczema conditions in individuals with eczema as compared to consumption of regular eggs.
详细描述
Eczema refers to a group of conditions that induces inflammation of the skin. Of which, atopic dermatitis is the most common type. Eczema is common in children, and can continue to adulthood. Eczema is a chronic condition with no known cure.
Anti-inflammatory agents have been shown to protect against atopic dermatitis. Vitamin D, E and polyunsaturated fatty acids are known to confer excellent anti-inflammatory benefits.
This is a double-blinded, randomized, parallel study and all subjects will complete a 12-week study period. The study was designed based on previous research which reported that omega-3 supplementation significantly decreased blood IgE concentration (-29.0 ± 11.1, mean ± SD) compared to placebo supplementation (-7.7 ± 14.6, mean ± SD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-literate and able to give informed consent in English
- •Male and female subjects, aged between 21 and 59 inclusive
- •Healthy individuals with no comorbidities or on regular medication
- •BMI between 18.5-25 kg/m2
- •Mild to moderate severity of eczema, which will also be determined using our questionnaires during screening visit
排除标准
- •Significant change in body weight (3 kg or more) in the past 3 months
- •Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week
- •Known food allergy to eggs
- •Taking dietary supplements which may impact the study results
- •Had been diagnosed or with a history of gastrointestinal disorders e.g. irritable bowel syndrome, constipation, diverticulitis
- •Current smokers
- •Consumes more than 2 alcoholic drinks per day i.e. one drink is defined as either 150ml of wine, 340ml of beer/cider or 45ml of distilled spirit
- •Taking lipid-lowering and blood pressure controlling medications less than 3 years
- •Pregnant or lactating women, or planning to conceive in the next 6 months
- •Unwilling to stop the medication of eczema during the study, either topical creams or oral medications
- •Hierarchical link (professional and familial ties) with the research team members
- •Participating in another clinical study
- •Having blindness in one eye or more, previously diagnosed eye diseases, or have had eye surgery
- •Low quality macular pigment optical density results, determined during screening visit
结局指标
主要结局
Change in eczema severity using the SCORing Atopic Dermatitis (SCORAD) index
时间窗: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
The SCORAD index is a validated composite scoring instrument designed to assess signs and symptoms of atopic dermatitis (AD). Total score ranges from 0 to 103, with higher scores indicating greater severity.
Change in skin sebum level using sebumeter
时间窗: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
A sebumeter is an electronic device used to measure sebum levels on the skin surface
Change in blood Low-density Lipoprotein-cholesterol (LDL) level
时间窗: Every 6 weeks (Week 0, Week 6, Week 12)
LDL concentration in blood samples will be measured
Change in blood High-density Lipoprotein-cholesterol (HDL) level
时间窗: Every 6 weeks (Week 0, Week 6, Week 12)
HDL concentration in blood samples will be measured
Change in eczema severity using the Eczema Area Severity Index (EASI)
时间窗: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
The EASI is a validated objective instrument for assessing signs of AD. Total score ranges from 0 to 72, with higher scores indicating greater severity.
Change in skin hydration level using corneometer
时间窗: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
A corneometer is an electronic device used to measure hydration on the skin surface
Change in malondialdehyde level
时间窗: Every 6 weeks (Week 0, Week 6, Week 12)
Malondialdehyde concentration in blood samples will be measured
Change in skin quality of life assessment using the Dermatology Life Quality Index (DLQI)
时间窗: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
The DLQI is a validated self-reported instrument assessing the self perception of impact of skin diseases on their quality of life over the previous week. Scores range from 0 to 30, with higher scores indicating greater impairment on quality of life.
Change in transepidermal water loss level using tewameter
时间窗: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
A tewameter is an electronic device used to measure transepidermal water loss on the skin surface
Change in skin pH level using pH probe
时间窗: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
A pH probe is an electronic device used to measure pH levels on the skin surface
Change in tumor necrosis factor α
时间窗: Every 6 weeks (Week 0, Week 6, Week 12)
Tumor necrosis factor α concentration in blood samples will be measured
Change in fasting blood glucose level
时间窗: Every 6 weeks (Week 0, Week 6, Week 12)
Fasting glucose concentration in blood samples will be measured
Change in blood total cholesterol level
时间窗: Every 6 weeks (Week 0, Week 6, Week 12)
Total cholesterol levels in blood samples will be measured
Change in stratum corneum components via immune dot blot assay
时间窗: Baseline and Week 12
Outermost skin surface components will be extracted to conduct dot blot assays to assess changes during intervention period
Change in 8-iso-prostaglandin F2α level
时间窗: Every 6 weeks (Week 0, Week 6, Week 12)
8-iso-prostaglandin F2α concentration in blood samples will be measured
Change in interleukin-6 level
时间窗: Every 6 weeks (Week 0, Week 6, Week 12)
Interleukin-6 concentration in blood samples will be measured
Change in blood triglyceride level
时间窗: Every 6 weeks (Week 0, Week 6, Week 12)
Triglyceride concentration in blood samples will be measured
次要结局
- Change in Contrast Sensitivity using eye chart(Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12))
- Change in Eye Carotenoid levels using Macular Pigment Scanner(Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12))
- Change in Skin Advanced Glycation End-product (AGEs)(Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12))
- Change in Eye Visual Function using the NEI VFQ-25(Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12))
- Change in Visual Acuity using eye chart(Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12))
- Change in Photostress Recovery Time using eye chart(Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12))
- Change in Blood Carotenoid levels using High Performance Liquid Chromatography (HPLC)(Every 6 weeks (Week 0, Week 6, Week 12))
- Change in Blood AGEs(Every 6 weeks (Week 0, Week 6, Week 12))
- Change in Skin Carotenoid levels using BioPhotonic Scanner(Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12))
研究者
Jung Eun Kim
Assistant Professor
National University of Singapore