Impact of Regular Consumption of Eggs and Nutrients Fortified Eggs on Eczema Condition in Singapore Individuals

Aging Clinical Trial

Official title:

Impact of Regular Consumption of Eggs and Nutrients Fortified Eggs on Eczema Condition in Singapore Individuals With Eczema

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06454942
• Other study ID #: S26
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: National University of Singapore
• Contact: Yuxin LIANG
• Phone: 6580672043
• Email: yuxinliang[@]u.nus.edu
• 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 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: May 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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 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.

Related Conditions & MeSH terms

• Aging
• Atopic Dermatitis Eczema
• Dermatitis
• Dermatitis, Atopic
• Diet Modification
• Eczema

Intervention

Dietary Supplement:
• Nutrient-fortified egg
Consumption of nutrient-fortified eggs with habitual diet
• Regular egg with habitual diet
Consumption of regular egg with habitual diet

Locations

Country	Name	City	State
n/a

Sponsors (3)

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

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary assessment	3-day food record will be used to assess participants' dietary intake for two weekdays and one weekend day before each clinical visit.	Week 0, week 3, week 6, week 9, week 12
Other	Measurement of height	Height will be measured using height-weight scale and units will be in cm.	Week 0, week 3, week 6, week 9, week 12
Other	Measurement of blood pressure	A blood pressure monitoring device available commercially will be used be to measure their systolic and diastolic blood pressure. Unit is mmHg.	Week 0, week 3, week 6, week 9, week 12
Other	Measurement of weight	Weight will be measured using height-weight scale and units will be in kg.	Week 0, week 3, week 6, week 9, week 12
Other	Measurement of waist circumference	Waist circumference will be measured using a measuring tape by a trained personnel, units in cm.	Week 0, week 3, week 6, week 9, week 12
Primary	Skin questionnaires - SCORing Atopic Dermatitis (SCORAD) Index	SCORing Atopic Dermatitis (SCORAD) Index is a clinical tool used to assess the severity of atopic dermatitis (AD), also known as eczema. This index can estimate participants' body surface area affected by burns (extent - A: percentage of body surface area affected), Intensity (B: clinical signs are assessed and scored on a scale from 0 (absent) to 3 (severe)), Subjective Symptoms (C: itch, sleep disturbance are evaluated based on the participants' report over the past three days, each scored on a scale from 0 (no symptom) to 10(severe symptom)).; The SCORAD index is calculated using the following formula: SCORAD=A/5+7B/2+C; Interpretation Mild atopic dermatitis: SCORAD < 25 Moderate atopic dermatitis: SCORAD 25-50 Severe atopic dermatitis: SCORAD > 50	Week 0, week 3, week 6, week 9, week 12
Primary	Skin questionnaires - Eczema Area and Severity Index (EASI) scoring system	EASI evaluates the extent and severity of eczema in four body regions: the head and neck, the trunk, the upper limbs, and the lower limbs.; The EASI score ranges from 0 to 72, with higher scores indicating more severe eczema: 0: No eczema 1-7: Mild eczema 8-21: Moderate eczema 22-50: Severe eczema 51-72: Very severe eczema	Week 0, week 3, week 6, week 9, week 12
Primary	Skin questionnaires - Dermatology life quality index (DLQI)	DLQI is a dermatology-specific instrument used to measure the impact of skin diseases on patients' quality of life. Which assessed disease impact, monitor treatment effectiveness, guide clinical decision-making.; Interpretation of Scores: 0-1: No effect on patient's life 2-5: Small effect on patient's life 6-10: Moderate effect on patient's life 11-20: Very large effect on patient's life 21-30: Extremely large effect on patient's life	Week 0, week 3, week 6, week 9, week 12
Primary	Skin measurement - eczema related	Skin hydration - units arbitrary Corneometer®. Transepidermal water loss - units gram/hour. Sebum level - unit µg/cm2. Skin pH level - skin pH meter. Skin tape stripping: stratum corneum components assessed by immune dot blots	Week 0, week 3, week 6, week 9, week 12
Primary	Skin carotenoids status	Skin carotenoids concentration can be measured by Resonance Raman Spectroscopy, unit is skin carotenoid score, higher score means optimal, lower score means poor condition of skin carotenoids.	Week 0, week 3, week 6, week 9, week 12
Primary	Blood carotenoids levels	Blood carotenoids levels can be measured by High-Performance Liquid Chromatography, unit is µmol/L.	Week 0, week 6, week 12
Secondary	Eye health - Macular Pigment Optical Density	A measurement of macular pigment of the eye using a heterochromatic flicker photometry device. The measurements are in arbitrary units.	Week 0, week 3, week 6, week 9, week 12
Secondary	Eye health - Visual acuity	Participants will read out letters on a ETDRS LogMAR chart at a fixed distance where letters becomes smaller as it goes down the chart. Tests results will be recorded in number of letters read, where the more letters the better the outcome.	Week 0, week 3, week 6, week 9, week 12
Secondary	Eye health - Photostress recovery time	An ophthalmoscope will be used to shine a light into the participants eye for 10 seconds, and participants will be required to read letters off a chart the moment their vision returns to normal. The faster the recovery time, the better the outcome. Units will be in seconds	Week 0, week 3, week 6, week 9, week 12
Secondary	Visual function questionnaire 25	A questionnaire to for participants to self-evaluate their perception of their current eye health based on general vision, ocular pain, near activities, distance activities, vision specific functions, driving, color vision and peripheral vision. The best possible score is 100 and worst possible score is 0.	Week 0, week 3, week 6, week 9, week 12
Secondary	Concentration of tumour necrosis factor-a	The blood obtained from the participants will be processed for storage. Tumor necrosis factor-a results will be presented in ng/L according to the commercially available enzyme-linked immunosorbent assay kits.	Week 0, week 6, week 12
Secondary	Concentration of interleukin-6	The blood obtained from the participants will be processed for storage. Interleukin-6 results will be presented in ng/L according to the commercially available enzyme-linked immunosorbent assay kits.	Week 0, week 6, week 12
Secondary	Concentration of high-sensitivity C-reactive protein	The blood obtained from the participants will be processed for storage. High-sensitivity C-reactive protein results will be obtained and presented in mg/L by commercial lab testing.	Week 0, week 6, week 12
Secondary	Concentration of fasting blood glucose	Fasting blood glucose will be measured using commercial lab testing using participants' blood, units will be in mmol/L.	Week 0, week 6, week 12
Secondary	Concentration of malondialdehyde	The blood obtained from the participants will be processed for storage. Analyses of malondialdehyde using commercially available enzyme-linked immunosorbent assay kits. Units for malondialdehyde will be in ng/L according to assay kit instructions.	Week 0, week 6, week 12
Secondary	Concentration of 8-isoprostaglandin-F2a	The blood obtained from the participants will be processed for storage. Analyses of 8-isoprostaglandin-F2a using commercially available enzyme-linked immunosorbent assay kits. Units for 8-isoprostaglandin-F2a will be in µmol/L according to assay kit instructions.	Week 0, week 6, week 12
Secondary	Concentration of insulin	Fasting blood insulin will be measured using commercial lab testing using participants' blood, units in µU/L.	Week 0, week 6, week 12
Secondary	Percentage of glycated hemoglobin	Glycated hemoglobin will be measured using commercial lab testing from participant's blood, units in percent.	Week 0, week 6, week 12
Secondary	Skin advanced glycation end products levels	Measurement of skin advanced glycation end products level using a skin autofluorescence device, where participants wlll be instructed to place their forearm over the device and a light will be shone and a reading can be captured by detecting fluorescence. The results will be presented as arbitrary units.	Week 0, week 3, week 6, week 9, week 12
Secondary	Blood advanced glycation end products levels	Participants will have their blood drawn by medical professionals at the Occupational Health Clinic. The blood will be processed and stored. Measurements will be done using ultra-performance liquid chromatography coupled with mass spectrometry techniques to determine the levels of advanced glycation end products. Units will be in µg/mL.	Week 0, week 3, week 6, week 9, week 12