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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypersensitivity; Eczema; Inflammation; Skin; Eczema, Atopic
• Intervention / Treatment: Dietary supplement: Nutrients-fortified egg; Other: Regular egg

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117546
    • National University of Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

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)

Collaborators and Investigators

• Sponsor: National University of Singapore
• Collaborators: Ministry of Education, Singapore
• Investigators: Principal Investigator: Jung Eun Kim, PhD, Food Science and technology, Faculty of Science, National University of Singapore

Publications and helpful links

General Publications

• Ito N, Seki S, Ueda F. The Protective Role of Astaxanthin for UV-Induced Skin Deterioration in Healthy People-A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2018 Jun 25;10(7):817. doi: 10.3390/nu10070817.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): July 31, 2023
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Vitamin D; Vitamin E; Eczema; Antioxidant; Egg; Omega-3 long chain polyunsaturated fatty acids
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Diseases, Eczematous; Hypersensitivity; Inflammation; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: S17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No