An interventional study of Nutrients-fortified egg and Regular egg in Eczema, Atopic, Inflammation; Skin and Eczema, sponsored by National University of Singapore. Active, not recruiting at 1 site in Singapore. Open to participants aged 21 Years to 59 Years. Per ClinicalTrials.gov, last updated 2023-11-09.
Sponsored by National University of Singapore · Not applicable, Interventional, and Supportive care
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).
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 41 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →National University of Singapore is the lead sponsor of 206 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 cooked nutrients fortified eggs (half-boiled, hard-boiled, or steamed)
Consumption of 2 regular eggs, prepared in the same manner as nutrients-fortified egg, which serves as a placebo comparison.
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)
Change in skin sebum level using sebumeter
A sebumeter is an electronic device used to measure sebum levels on the skin surface
Time frame: 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
Time frame: Baseline and Week 12
Change in malondialdehyde level
Malondialdehyde concentration in blood samples will be measured
Time frame: 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
Time frame: Every 6 weeks (Week 0, Week 6, Week 12)
Change in interleukin-6 level
Interleukin-6 concentration in blood samples will be measured
Time frame: 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
Time frame: Every 6 weeks (Week 0, Week 6, Week 12)
Change in fasting blood glucose level
Fasting glucose concentration in blood samples will be measured
Time frame: Every 6 weeks (Week 0, Week 6, Week 12)
Change in blood triglyceride level
Triglyceride concentration in blood samples will be measured
Time frame: Every 6 weeks (Week 0, Week 6, Week 12)
Change in blood total cholesterol level
Total cholesterol levels in blood samples will be measured
Time frame: 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
Time frame: 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
Time frame: Every 6 weeks (Week 0, Week 6, Week 12)
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)
Plan to share: No — Hard copy documents containing identifiable participant information will be stored in locked storage cabinets accessible only to members of the NUS research group. These locked storage cabinets are located in Kim lab in NUS. This lab is accessible only to Dr Kim Jung Eun, the Principal Investigator, and Dr Kim's research staff. The lab has a dual access security system, with the first entry point being an electronic lock accessible by an NUS-approved key card and the second is a physical lock. Electronic copies of the data with identifiable participant information stored electronically in NUS OneDrive. Only members of Dr Kim's lab have access to this secured folder. Access to this OneDrive folder is only granted by Dr Kim. All study samples will be de-identified prior to analysis and statistical analyses.
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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National University of Singapore