Aging, Atopic Dermatitis Eczema, Diet Modification
Conditions
Keywords
Atopic Dermatitis, Eczema, Young and Middle-aged adults, Eye health, Antioxidants
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.
Interventions
DIETARY_SUPPLEMENTNutrient-fortified egg
Consumption of nutrient-fortified eggs with habitual diet
DIETARY_SUPPLEMENTRegular egg with habitual diet
Consumption of regular egg with habitual diet
Sponsors
National University Hospital, Singapore
Ministry of Education, Singapore
National University of Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 59 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood carotenoids levels | Week 0, week 6, week 12 | Blood carotenoids levels can be measured by High-Performance Liquid Chromatography, unit is μmol/L. |
| Skin carotenoids status | 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. |
| Skin measurement - eczema related | 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 |
| Skin questionnaires - Eczema Area and Severity Index (EASI) scoring system | 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 |
| Skin questionnaires - Dermatology life quality index (DLQI) | 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 |
| Skin questionnaires - SCORing Atopic Dermatitis (SCORAD) Index | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of interleukin-6 | 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. |
| Concentration of high-sensitivity C-reactive protein | 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. |
| Concentration of malondialdehyde | 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. |
| Concentration of 8-isoprostaglandin-F2α | 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. |
| Concentration of insulin | Week 0, week 6, week 12 | Fasting blood insulin will be measured using commercial lab testing using participants' blood, units in μU/L. |
| Percentage of glycated hemoglobin | Week 0, week 6, week 12 | Glycated hemoglobin will be measured using commercial lab testing from participant's blood, units in percent. |
| Skin advanced glycation end products levels | 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. |
| Blood advanced glycation end products levels | 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. |
| Concentration of fasting blood glucose | 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. |
| Eye health - Macular Pigment Optical Density | 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. |
| Eye health - Visual acuity | 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. |
| Eye health - Photostress recovery time | 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 |
| Visual function questionnaire 25 | 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. |
| Concentration of tumour necrosis factor-α | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dietary assessment | 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. |
| Measurement of waist circumference | 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. |
| Measurement of weight | Week 0, week 3, week 6, week 9, week 12 | Weight will be measured using height-weight scale and units will be in kg. |
| Measurement of blood pressure | 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. |
| Measurement of height | Week 0, week 3, week 6, week 9, week 12 | Height will be measured using height-weight scale and units will be in cm. |
Countries
Singapore
Contacts
Primary ContactYuxin LIANG
Outcome results
None listed