Department of Food Science and Techonology, Block S13
Singapore, 117550
Location status: Recruiting
NCT Number: NCT06454942
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
Interested in participating?
Request Info21 year–59 year
All sexes
Interventional
Not applicable
Singapore, 117550
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Consumption of nutrient-fortified eggs with habitual diet
Consumption of regular egg with habitual diet
Time frame: Week 0, week 3, week 6, week 9, week 12
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
Time frame: Week 0, week 3, week 6, week 9, week 12
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
Time frame: Week 0, week 3, week 6, week 9, week 12
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
Time frame: Week 0, week 3, week 6, week 9, week 12
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
Time frame: Week 0, week 3, week 6, week 9, week 12
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.
Time frame: Week 0, week 6, week 12
Blood carotenoids levels can be measured by High-Performance Liquid Chromatography, unit is μmol/L.
Time frame: Week 0, week 3, week 6, week 9, week 12
A measurement of macular pigment of the eye using a heterochromatic flicker photometry device. The measurements are in arbitrary units.
Time frame: Week 0, week 3, week 6, week 9, week 12
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.
Time frame: Week 0, week 3, week 6, week 9, week 12
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
Time frame: Week 0, week 3, week 6, week 9, week 12
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.
Time frame: Week 0, week 6, week 12
The blood obtained from the participants will be processed for storage. Tumor necrosis factor-α results will be presented in ng/L according to the commercially available enzyme-linked immunosorbent assay kits.
Time frame: Week 0, week 6, week 12
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.
Time frame: Week 0, week 6, week 12
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.
Time frame: Week 0, week 6, week 12
Fasting blood glucose will be measured using commercial lab testing using participants' blood, units will be in mmol/L.
Time frame: Week 0, week 6, week 12
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.
Time frame: Week 0, week 6, week 12
The blood obtained from the participants will be processed for storage. Analyses of 8-isoprostaglandin-F2α using commercially available enzyme-linked immunosorbent assay kits. Units for 8-isoprostaglandin-F2α will be in µmol/L according to assay kit instructions.
Time frame: Week 0, week 6, week 12
Fasting blood insulin will be measured using commercial lab testing using participants' blood, units in μU/L.
Time frame: Week 0, week 6, week 12
Glycated hemoglobin will be measured using commercial lab testing from participant's blood, units in percent.
Time frame: Week 0, week 3, week 6, week 9, week 12
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.
Time frame: Week 0, week 3, week 6, week 9, week 12
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.
Time frame: Week 0, week 3, week 6, week 9, week 12
3-day food record will be used to assess participants' dietary intake for two weekdays and one weekend day before each clinical visit.
Time frame: Week 0, week 3, week 6, week 9, week 12
Height will be measured using height-weight scale and units will be in cm.
Time frame: Week 0, week 3, week 6, week 9, week 12
A blood pressure monitoring device available commercially will be used be to measure their systolic and diastolic blood pressure. Unit is mmHg.
Time frame: Week 0, week 3, week 6, week 9, week 12
Weight will be measured using height-weight scale and units will be in kg.
Time frame: Week 0, week 3, week 6, week 9, week 12
Waist circumference will be measured using a measuring tape by a trained personnel, units in cm.
Contact information is provided by the study sponsor or research team.
National University of Singapore
Other
Impact of Regular Consumption of Eggs and Nutrients Fortified Eggs on Eczema Condition in Singapore Individuals With Eczema
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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