Impact of Regular Consumption of Eggs and Nutrients Fortified Eggs on Eczema Condition in Singapore Individuals With Eczema
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Skin questionnaires - 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 Singapore individuals with eczema. The investigators hypothesize that egg consumption will improve eczema condition and nutrients fortified egg consumption will improve further improvements when compared to standard egg consumption in individuals with eczema
详细描述
This is a double-blind, randomized, parallel study and all subjects will complete a 12-week study period. Subjects will be tasked to consume nutrients-fortified eggs and regular eggs daily for 12 weeks. After which, subjects are assessed for changes in carotenoid status, antioxidant and anti-inflammatory biomarkers, skin and eye health measurements, and other biomarkers of health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •English-literate and able to give informed consent in English
- •Male and female participants, aged between 21 and 59 inclusive
- •Healthy individuals with no underlying condition 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 the 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
- •Having gastrointestinal disorders not suitable for the study
- •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 for 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, eye diseases, retinal/lens/optical nerve surgery, or other eye conditions that may impact the study results
- •Low-quality macular pigment optical density results were determined during the screening visit.
结局指标
主要结局
Skin questionnaires - SCORing Atopic Dermatitis (SCORAD) Index
时间窗: Week 0, week 3, week 6, week 9, week 12
SCORing Atopic Dermatitis (SCORAD) Index is a clinical tool used to assess the severity of atopic dermatitis (AD), also known as eczema. This index can estimate participants' body surface area affected by burns (extent - A: percentage of body surface area affected), Intensity (B: clinical signs are assessed and scored on a scale from 0 (absent) to 3 (severe)), Subjective Symptoms (C: itch, sleep disturbance are evaluated based on the participants' report over the past three days, each scored on a scale from 0 (no symptom) to 10(severe symptom)). The SCORAD index is calculated using the following formula: SCORAD=A/5+7B/2+C Interpretation Mild atopic dermatitis: SCORAD \< 25 Moderate atopic dermatitis: SCORAD 25-50 Severe atopic dermatitis: SCORAD \> 50
Skin questionnaires - Dermatology life quality index (DLQI)
时间窗: Week 0, week 3, week 6, week 9, week 12
DLQI is a dermatology-specific instrument used to measure the impact of skin diseases on patients' quality of life. Which assessed disease impact, monitor treatment effectiveness, guide clinical decision-making. Interpretation of Scores: 0-1: No effect on patient's life 2-5: Small effect on patient's life 6-10: Moderate effect on patient's life 11-20: Very large effect on patient's life 21-30: Extremely large effect on patient's life
Skin measurement - eczema related
时间窗: Week 0, week 3, week 6, week 9, week 12
Skin hydration - units arbitrary Corneometer®. Transepidermal water loss - units gram/hour. Sebum level - unit µg/cm2. Skin pH level - skin pH meter. Skin tape stripping: stratum corneum components assessed by immune dot blots
Skin questionnaires - Eczema Area and Severity Index (EASI) scoring system
时间窗: Week 0, week 3, week 6, week 9, week 12
EASI evaluates the extent and severity of eczema in four body regions: the head and neck, the trunk, the upper limbs, and the lower limbs. The EASI score ranges from 0 to 72, with higher scores indicating more severe eczema: 0: No eczema 1-7: Mild eczema 8-21: Moderate eczema 22-50: Severe eczema 51-72: Very severe eczema
Skin carotenoids status
时间窗: Week 0, week 3, week 6, week 9, week 12
Skin carotenoids concentration can be measured by Resonance Raman Spectroscopy, unit is skin carotenoid score, higher score means optimal, lower score means poor condition of skin carotenoids.
Blood carotenoids levels
时间窗: Week 0, week 6, week 12
Blood carotenoids levels can be measured by High-Performance Liquid Chromatography, unit is μmol/L.
次要结局
- Concentration of interleukin-6(Week 0, week 6, week 12)
- Concentration of fasting blood glucose(Week 0, week 6, week 12)
- Percentage of glycated hemoglobin(Week 0, week 6, week 12)
- Skin advanced glycation end products levels(Week 0, week 3, week 6, week 9, week 12)
- Eye health - Macular Pigment Optical Density(Week 0, week 3, week 6, week 9, week 12)
- Eye health - Visual acuity(Week 0, week 3, week 6, week 9, week 12)
- Eye health - Photostress recovery time(Week 0, week 3, week 6, week 9, week 12)
- Concentration of insulin(Week 0, week 6, week 12)
- Blood advanced glycation end products levels(Week 0, week 3, week 6, week 9, week 12)
- Visual function questionnaire 25(Week 0, week 3, week 6, week 9, week 12)
- Concentration of tumour necrosis factor-α(Week 0, week 6, week 12)
- Concentration of high-sensitivity C-reactive protein(Week 0, week 6, week 12)
- Concentration of malondialdehyde(Week 0, week 6, week 12)
- Concentration of 8-isoprostaglandin-F2α(Week 0, week 6, week 12)
研究者
Jung Eun Kim
Assistant Professor
National University of Singapore