Nutrients-fortified Egg Consumption on Eczema Condition in Individuals With Eczema
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nutrients-fortified egg 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
Consumption of 2 cooked nutrients fortified eggs (half-boiled, hard-boiled, or steamed)
|
| Placebo Comparator: Regular egg 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
Consumption of 2 regular eggs, prepared in the same manner as nutrients-fortified egg, which serves as a placebo comparison.
|
Outcome Measures
Primary Outcome Measures
- Change in eczema severity using the SCORing Atopic Dermatitis (SCORAD) index [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 eczema severity using the Eczema Area Severity Index (EASI) [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 quality of life assessment using the Dermatology Life Quality Index (DLQI) [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 skin hydration level using corneometer [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 transepidermal water loss level using tewameter [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 [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 skin sebum level using sebumeter [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 stratum corneum components via immune dot blot assay [Baseline and Week 12]
Outermost skin surface components will be extracted to conduct dot blot assays to assess changes during intervention period
- Change in malondialdehyde level [Every 6 weeks (Week 0, Week 6, Week 12)]
Malondialdehyde concentration in blood samples will be measured
- Change in 8-iso-prostaglandin F2α level [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 [Every 6 weeks (Week 0, Week 6, Week 12)]
Interleukin-6 concentration in blood samples will be measured
- Change in tumor necrosis factor α [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 [Every 6 weeks (Week 0, Week 6, Week 12)]
Fasting glucose concentration in blood samples will be measured
- Change in blood triglyceride level [Every 6 weeks (Week 0, Week 6, Week 12)]
Triglyceride concentration in blood samples will be measured
- Change in blood total cholesterol level [Every 6 weeks (Week 0, Week 6, Week 12)]
Total cholesterol levels in blood samples will be measured
- Change in blood Low-density Lipoprotein-cholesterol (LDL) level [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 [Every 6 weeks (Week 0, Week 6, Week 12)]
HDL concentration in blood samples will be measured
Secondary Outcome Measures
- Change in Blood Carotenoid levels using High Performance Liquid Chromatography (HPLC) [Every 6 weeks (Week 0, Week 6, Week 12)]
Carotenoid concentration in blood samples will be measured
- Change in Skin Carotenoid levels using BioPhotonic Scanner [Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)]
Skin carotenoid levels will be measured from the skin surface
- Change in Eye Carotenoid levels using Macular Pigment Scanner [Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)]
Eye carotenoid levels will be measured using the Macular Pigment Scanner MPSII
- Change in Skin Advanced Glycation End-product (AGEs) [Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)]
Skin AGEs will be quantified using a noninvasive scanner
- Change in Blood AGEs [Every 6 weeks (Week 0, Week 6, Week 12)]
Blood AGEs concentration in blood samples will be measured
- Change in Eye Visual Function using the NEI VFQ-25 [Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)]
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.
- Change in Visual Acuity using eye chart [Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)]
Visual acuity is a measure of visual function and it will be assessed by an investigator
- Change in Contrast Sensitivity using eye chart [Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)]
Contrast sensitivity is a measure of visual function and it will be assessed by an investigator
- Change in Photostress Recovery Time using eye chart [Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)]
Photostress recovery assessment is a measure of visual function and it will be assessed by an investigator
Eligibility Criteria
Criteria
Inclusion Criteria:
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English-literate and able to give informed consent in English
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Male and female subjects, aged between 21 and 59 inclusive
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Healthy individuals with no comorbidities or on regular medication
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BMI between 18.5-25 kg/m2
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Mild to moderate severity of eczema, which will also be determined using our questionnaires during screening visit
Exclusion Criteria:
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Significant change in body weight (3 kg or more) in the past 3 months
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Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week
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Known food allergy to eggs
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Taking dietary supplements which may impact the study results
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Had been diagnosed or with a history of gastrointestinal disorders e.g. irritable bowel syndrome, constipation, diverticulitis
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Current smokers
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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
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Taking lipid-lowering and blood pressure controlling medications less than 3 years
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Pregnant or lactating women, or planning to conceive in the next 6 months
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Unwilling to stop the medication of eczema during the study, either topical creams or oral medications
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Hierarchical link (professional and familial ties) with the research team members
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Participating in another clinical study
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Having blindness in one eye or more, previously diagnosed eye diseases, or have had eye surgery
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Low quality macular pigment optical density results, determined during screening visit
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National University of Singapore | Singapore | Singapore | 117546 |
Sponsors and Collaborators
- National University of Singapore
- Ministry of Education, Singapore
Investigators
- Principal Investigator: Jung Eun Kim, PhD, Food Science and technology, Faculty of Science, National University of Singapore
Study Documents (Full-Text)
None provided.More Information
Publications
- S17