Nutrients-fortified Egg Consumption on Eczema Condition in Individuals With Eczema

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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).

Official Title
-----------------
Impact of Nutrients-fortified Egg Consumption on Eczema Condition in Individuals With Eczema

Conditions
-----------------
Eczema, Atopic, Inflammation; Skin, Eczema, Hypersensitivity

Intervention / Treatment
-----------------
* Dietary Supplement: Nutrients-fortified egg
* Other: Regular egg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrients-fortified egg<br>Each subject will be provided with 2 nutrients-fortified eggs from N&N Agriculture Pte Ltd to consume daily for 12 weeks. They will be instructed to consume the eggs for breakfast with the following preparation methods: hard-boiling, half-boiling and steaming. Subjects are to continue their usual diet. | Dietary Supplement: Nutrients-fortified egg<br>* Consumption of 2 cooked nutrients fortified eggs (half-boiled, hard-boiled, or steamed)<br>|
| Placebo Comparator: Regular egg<br>Each subject will be provided with 2 regular eggs to consume daily for 12 weeks. They will be instructed to consume the eggs for breakfast with the following preparation methods: hard-boiling, half-boiling and steaming. Subjects are to continue their usual diet. | Other: Regular egg<br>* Consumption of 2 regular eggs, prepared in the same manner as nutrients-fortified egg, which serves as a placebo comparison.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in eczema severity using the SCORing Atopic Dermatitis (SCORAD) index | 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. | Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12) | 
| Change in eczema severity using the Eczema Area Severity Index (EASI) | 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. | Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12) | 
| Change in skin quality of life assessment using the Dermatology Life Quality Index (DLQI) | 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. | Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12) | 
| Change in skin hydration level using corneometer | A corneometer is an electronic device used to measure hydration on the skin surface | Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12) | 
| Change in transepidermal water loss level using tewameter | A tewameter is an electronic device used to measure transepidermal water loss on the skin surface | Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12) | 
| Change in skin pH level using pH probe | A pH probe is an electronic device used to measure pH levels on the skin surface | Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12) | 
| Change in skin sebum level using sebumeter | A sebumeter is an electronic device used to measure sebum levels on the skin surface | Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12) | 
| Change in stratum corneum components via immune dot blot assay | Outermost skin surface components will be extracted to conduct dot blot assays to assess changes during intervention period | Baseline and Week 12 | 
| Change in malondialdehyde level | Malondialdehyde concentration in blood samples will be measured | Every 6 weeks (Week 0, Week 6, Week 12) | 
| Change in 8-iso-prostaglandin F2α level | 8-iso-prostaglandin F2α concentration in blood samples will be measured | Every 6 weeks (Week 0, Week 6, Week 12) | 
| Change in interleukin-6 level | Interleukin-6 concentration in blood samples will be measured | Every 6 weeks (Week 0, Week 6, Week 12) | 
| Change in tumor necrosis factor α | Tumor necrosis factor α concentration in blood samples will be measured | Every 6 weeks (Week 0, Week 6, Week 12) | 
| Change in fasting blood glucose level | Fasting glucose concentration in blood samples will be measured | Every 6 weeks (Week 0, Week 6, Week 12) | 
| Change in blood triglyceride level | Triglyceride concentration in blood samples will be measured | Every 6 weeks (Week 0, Week 6, Week 12) | 
| Change in blood total cholesterol level | Total cholesterol levels in blood samples will be measured | Every 6 weeks (Week 0, Week 6, Week 12) | 
| Change in blood Low-density Lipoprotein-cholesterol (LDL) level | LDL concentration in blood samples will be measured | Every 6 weeks (Week 0, Week 6, Week 12) | 
| Change in blood High-density Lipoprotein-cholesterol (HDL) level | HDL concentration in blood samples will be measured | Every 6 weeks (Week 0, Week 6, Week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Carotenoid levels using High Performance Liquid Chromatography (HPLC) | Carotenoid concentration in blood samples will be measured | Every 6 weeks (Week 0, Week 6, Week 12) | 
| Change in Skin Carotenoid levels using BioPhotonic Scanner | Skin carotenoid levels will be measured from the skin surface | Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12) | 
| Change in Eye Carotenoid levels using Macular Pigment Scanner | Eye carotenoid levels will be measured using the Macular Pigment Scanner MPSII | Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12) | 
| Change in Skin Advanced Glycation End-product (AGEs) | Skin AGEs will be quantified using a noninvasive scanner | Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12) | 
| Change in Blood AGEs | Blood AGEs concentration in blood samples will be measured | Every 6 weeks (Week 0, Week 6, Week 12) | 
| Change in Eye Visual Function using the NEI VFQ-25 | The National Eye Institute Visual Functioning Questonnaire-25 (NEI VFQ-25) is a self-reported instrument designed to assess visual disability and health-related quality of life. The overall composite score ranges from 0 to 100, with a higher score indicating better visual function and better quality of life. | Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12) | 
| Change in Visual Acuity using eye chart | Visual acuity is a measure of visual function and it will be assessed by an investigator | Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12) | 
| Change in Contrast Sensitivity using eye chart | Contrast sensitivity is a measure of visual function and it will be assessed by an investigator | Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12) | 
| Change in Photostress Recovery Time using eye chart | Photostress recovery assessment is a measure of visual function and it will be assessed by an investigator | Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Egg, Vitamin D, Vitamin E, Antioxidant, Eczema, Omega-3 long chain polyunsaturated fatty acids