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

Eczema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05913791
• Other study ID #: S17
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: January 2025

Study information

• Verified date: November 2023
• Source: National University of Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: January 2025
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Eczema, Atopic
• Hypersensitivity
• Inflammation
• Inflammation; Skin

Intervention

Dietary Supplement:
• Nutrients-fortified egg
Consumption of 2 cooked nutrients fortified eggs (half-boiled, hard-boiled, or steamed)

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

Locations

Country	Name	City	State
Singapore	National University of Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University of Singapore	Ministry of Education, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	Change in malondialdehyde level	Malondialdehyde concentration in blood samples will be measured	Every 6 weeks (Week 0, Week 6, Week 12)
Primary	Change in 8-iso-prostaglandin F2a level	8-iso-prostaglandin F2a concentration in blood samples will be measured	Every 6 weeks (Week 0, Week 6, Week 12)
Primary	Change in interleukin-6 level	Interleukin-6 concentration in blood samples will be measured	Every 6 weeks (Week 0, Week 6, Week 12)
Primary	Change in tumor necrosis factor a	Tumor necrosis factor a concentration in blood samples will be measured	Every 6 weeks (Week 0, Week 6, Week 12)
Primary	Change in fasting blood glucose level	Fasting glucose concentration in blood samples will be measured	Every 6 weeks (Week 0, Week 6, Week 12)
Primary	Change in blood triglyceride level	Triglyceride concentration in blood samples will be measured	Every 6 weeks (Week 0, Week 6, Week 12)
Primary	Change in blood total cholesterol level	Total cholesterol levels in blood samples will be measured	Every 6 weeks (Week 0, Week 6, Week 12)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Change in Blood AGEs	Blood AGEs concentration in blood samples will be measured	Every 6 weeks (Week 0, Week 6, Week 12)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)