Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National University Hospital, Singapore | OTHER |
| Ministry of Education, Singapore | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular egg with habitual diet | Experimental | Each subject will be provide one-on-one dietary counselling and written instructions for each subject will be provided by a research dietitian and trained research staff.Subjects will also be provided with 2 regular egg/day for 12 weeks. |
|
| Nutrient-fortified egg with habitual diet | Experimental | Each subject will be provide one-on-one dietary counselling and written instructions for each subject will be provided by a research dietitian and trained research staff.Subjects will also be provided with 2 nutrient-fortified egg/day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrient-fortified egg | Dietary Supplement | Consumption of nutrient-fortified eggs with habitual diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Eye health - Visual acuity |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measurement of height |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuxin LIANG | Contact | 6580672043 | yuxinliang@u.nus.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jung Eun Kim, PhD, RD | National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Food Science and Techonology, Block S13 | Recruiting | Singapore | 117550 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29495607 | Background | 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. | |
| 34157098 | Background | 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. |
Not provided
Not provided
The link between participants' information data and the code will be kept confidential by the NUS research team or a trusted third party. Research data and results will only be collated in its coded format. All research data collected will be retained for a minimum of 10 years following the NUS Research Data Management Policy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Regular egg with habitual diet | Dietary Supplement | Consumption of regular egg with habitual diet |
|
| Week 0, week 3, week 6, week 9, week 12 |
| 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 |
| Blood carotenoids levels | Blood carotenoids levels can be measured by High-Performance Liquid Chromatography, unit is μmol/L. | Week 0, week 6, 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.
| Week 0, week 3, week 6, week 9, week 12 |
| 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 |
| 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 |
| Concentration of tumour necrosis factor-α | 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. | Week 0, week 6, week 12 |
| 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 |
| 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 |
| 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 |
| 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 |
| Concentration of 8-isoprostaglandin-F2α | 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. | Week 0, week 6, week 12 |
| 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 |
| 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 |
| 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 |
| 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 |
Height will be measured using height-weight scale and units will be in cm.
| Week 0, week 3, week 6, week 9, week 12 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided