Clinical trial NCT06454942: Impact of Regular Consumption of Eggs and Nutrients Fortified Eggs on Eczema Condition in Singapore Individuals
Official title: Impact of Regular Consumption of Eggs and Nutrients Fortified Eggs on Eczema Condition in Singapore Individuals With Eczema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis Eczema
Aging
Diet Modification
Keywords: Atopic Dermatitis
Eczema
Young and Middle-aged adults
Eye health
Antioxidants
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: National University Hospital, Singapore
name: Ministry of Education, Singapore
First posted: 2024-06-12
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to assess the effects of daily consumption of nutrients-fortified eggs on eczema condition in Singapore individuals with eczema. The investigators hypothesize that egg consumption will improve eczema condition and nutrients fortified egg consumption will improve further improvements when compared to standard egg consumption in individuals with eczema

Detailed description: This is a double-blind, randomized, parallel study and all subjects will complete a 12-week study period. Subjects will be tasked to consume nutrients-fortified eggs and regular eggs daily for 12 weeks. After which, subjects are assessed for changes in carotenoid status, antioxidant and anti-inflammatory biomarkers, skin and eye health measurements, and other biomarkers of health.

Eligibility criteria: Inclusion Criteria:

1. English-literate and able to give informed consent in English
2. Male and female participants, aged between 21 and 59 inclusive
3. Healthy individuals with no underlying condition 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 the 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. Having gastrointestinal disorders not suitable for the study
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 for 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, eye diseases, retinal/lens/optical nerve surgery, or other eye conditions that may impact the study results
14. Low-quality macular pigment optical density results were determined during the screening visit.

Primary outcomes:
measure: Skin questionnaires - SCORing Atopic Dermatitis (SCORAD) Index
timeFrame: Week 0, week 3, week 6, week 9, week 12
measure: Skin questionnaires - Eczema Area and Severity Index (EASI) scoring system
timeFrame: Week 0, week 3, week 6, week 9, week 12
measure: Skin questionnaires - Dermatology life quality index (DLQI)
timeFrame: Week 0, week 3, week 6, week 9, week 12
measure: Skin measurement - eczema related
timeFrame: Week 0, week 3, week 6, week 9, week 12
measure: Skin carotenoids status
timeFrame: Week 0, week 3, week 6, week 9, week 12
measure: Blood carotenoids levels
timeFrame: Week 0, week 6, week 12
Secondary outcomes:
measure: Eye health - Macular Pigment Optical Density
timeFrame: Week 0, week 3, week 6, week 9, week 12
measure: Eye health - Visual acuity
timeFrame: Week 0, week 3, week 6, week 9, week 12
measure: Eye health - Photostress recovery time
timeFrame: Week 0, week 3, week 6, week 9, week 12
measure: Visual function questionnaire 25
timeFrame: Week 0, week 3, week 6, week 9, week 12
measure: Concentration of tumour necrosis factor-α
timeFrame: Week 0, week 6, week 12
measure: Concentration of interleukin-6
timeFrame: Week 0, week 6, week 12
measure: Concentration of high-sensitivity C-reactive protein
timeFrame: Week 0, week 6, week 12
measure: Concentration of fasting blood glucose
timeFrame: Week 0, week 6, week 12
measure: Concentration of malondialdehyde
timeFrame: Week 0, week 6, week 12
measure: Concentration of 8-isoprostaglandin-F2α
timeFrame: Week 0, week 6, week 12
measure: Concentration of insulin
timeFrame: Week 0, week 6, week 12
measure: Percentage of glycated hemoglobin
timeFrame: Week 0, week 6, week 12
measure: Skin advanced glycation end products levels
timeFrame: Week 0, week 3, week 6, week 9, week 12
measure: Blood advanced glycation end products levels
timeFrame: Week 0, week 3, week 6, week 9, week 12
Other outcomes:
measure: Dietary assessment
timeFrame: Week 0, week 3, week 6, week 9, week 12
measure: Measurement of height
timeFrame: Week 0, week 3, week 6, week 9, week 12
measure: Measurement of blood pressure
timeFrame: Week 0, week 3, week 6, week 9, week 12
measure: Measurement of weight
timeFrame: Week 0, week 3, week 6, week 9, week 12
measure: Measurement of waist circumference
timeFrame: Week 0, week 3, week 6, week 9, week 12
Locations:
city: Singapore
country: Singapore
facility: Department of Food Science and Techonology, Block S13
Study officials:
affiliation: National University of Singapore
name: Jung Eun Kim, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Imai A, Oda Y, Ito N, Seki S, Nakagawa K, Miyazawa T, Ueda F. Effects of Dietary Supplementation of Astaxanthin and Sesamin on Daily Fatigue: A Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study. Nutrients. 2018 Feb 28;10(3):281. doi: 10.3390/nu10030281.
citation: Wilson LM, Tharmarajah S, Jia Y, Semba RD, Schaumberg DA, Robinson KA. The Effect of Lutein/Zeaxanthin Intake on Human Macular Pigment Optical Density: A Systematic Review and Meta-Analysis. Adv Nutr. 2021 Dec 1;12(6):2244-2254. doi: 10.1093/advances/nmab071.