Clinical trial NCT05913791: Nutrients-fortified Egg Consumption on Eczema Condition in Individuals With Eczema
Official title: Impact of Nutrients-fortified Egg Consumption on Eczema Condition in Individuals With Eczema
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Eczema, Atopic
Inflammation; Skin
Eczema
Hypersensitivity
Keywords: Egg
Vitamin D
Vitamin E
Antioxidant
Eczema
Omega-3 long chain polyunsaturated fatty acids
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Singapore
First posted: 2023-06-22
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in eczema severity using the SCORing Atopic Dermatitis (SCORAD) index
timeFrame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
measure: Change in eczema severity using the Eczema Area Severity Index (EASI)
timeFrame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
measure: Change in skin quality of life assessment using the Dermatology Life Quality Index (DLQI)
timeFrame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
measure: Change in skin hydration level using corneometer
timeFrame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
measure: Change in transepidermal water loss level using tewameter
timeFrame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
measure: Change in skin pH level using pH probe
timeFrame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
measure: Change in skin sebum level using sebumeter
timeFrame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
measure: Change in stratum corneum components via immune dot blot assay
timeFrame: Baseline and Week 12
measure: Change in malondialdehyde level
timeFrame: Every 6 weeks (Week 0, Week 6, Week 12)
measure: Change in 8-iso-prostaglandin F2α level
timeFrame: Every 6 weeks (Week 0, Week 6, Week 12)
measure: Change in interleukin-6 level
timeFrame: Every 6 weeks (Week 0, Week 6, Week 12)
measure: Change in tumor necrosis factor α
timeFrame: Every 6 weeks (Week 0, Week 6, Week 12)
measure: Change in fasting blood glucose level
timeFrame: Every 6 weeks (Week 0, Week 6, Week 12)
measure: Change in blood triglyceride level
timeFrame: Every 6 weeks (Week 0, Week 6, Week 12)
measure: Change in blood total cholesterol level
timeFrame: Every 6 weeks (Week 0, Week 6, Week 12)
measure: Change in blood Low-density Lipoprotein-cholesterol (LDL) level
timeFrame: Every 6 weeks (Week 0, Week 6, Week 12)
measure: Change in blood High-density Lipoprotein-cholesterol (HDL) level
timeFrame: Every 6 weeks (Week 0, Week 6, Week 12)
Secondary outcomes:
measure: Change in Blood Carotenoid levels using High Performance Liquid Chromatography (HPLC)
timeFrame: Every 6 weeks (Week 0, Week 6, Week 12)
measure: Change in Skin Carotenoid levels using BioPhotonic Scanner
timeFrame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
measure: Change in Eye Carotenoid levels using Macular Pigment Scanner
timeFrame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
measure: Change in Skin Advanced Glycation End-product (AGEs)
timeFrame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
measure: Change in Blood AGEs
timeFrame: Every 6 weeks (Week 0, Week 6, Week 12)
measure: Change in Eye Visual Function using the NEI VFQ-25
timeFrame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
measure: Change in Visual Acuity using eye chart
timeFrame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
measure: Change in Contrast Sensitivity using eye chart
timeFrame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
measure: Change in Photostress Recovery Time using eye chart
timeFrame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
affiliation: Food Science and technology, Faculty of Science, National University of Singapore
name: Jung Eun Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.