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

National University of Singapore41 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Eczema, Atopic Inflammation; Skin Eczema Hypersensitivity

Interventions

Nutrients-fortified eggDIETARY_SUPPLEMENT

Consumption of 2 cooked nutrients fortified eggs (half-boiled, hard-boiled, or steamed)

Regular eggOTHER

Consumption of 2 regular eggs, prepared in the same manner as nutrients-fortified egg, which serves as a placebo comparison.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 59 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. English-literate and able to give informed consent in English 2. Male and female subjects, aged between 21 and 59 inclusive 3. Healthy individuals with no comorbidities or on regular medication 4. BMI between 18.5-25 kg/m2 5. Mild to moderate severity of eczema, which will also be determined using our questionnaires during screening visit Exclusion Criteria: 1. Significant change in body weight (3 kg or more) in the past 3 months 2. Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week 3. Known food allergy to eggs 4. Taking dietary supplements which may impact the study results 5. Had been diagnosed or with a history of gastrointestinal disorders e.g. irritable bowel syndrome, constipation, diverticulitis 6. Current smokers 7. 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 8. Taking lipid-lowering and blood pressure controlling medications less than 3 years 9. Pregnant or lactating women, or planning to conceive in the next 6 months 10. Unwilling to stop the medication of eczema during the study, either topical creams or oral medications 11. Hierarchical link (professional and familial ties) with the research team members 12. Participating in another clinical study 13. Having blindness in one eye or more, previously diagnosed eye diseases, or have had eye surgery 14. Low quality macular pigment optical density results, determined during screening visit

Locations (1)

National University of Singapore

Singapore, Singapore

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Change in Blood Carotenoid levels using High Performance Liquid Chromatography (HPLC)

Carotenoid concentration in blood samples will be measured

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)