Atopic Dermatitis EczemaNCT06454942
Impact of Regular Consumption of Eggs and Nutrients Fortified Eggs on Eczema Condition in Singapore Individuals
A study testing Nutrient-fortified egg and Regular egg with habitual diet in people with Atopic Dermatitis Eczema and Aging, run by National University of Singapore at 1 site in Singapore.
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… Read more about this study
- Who is it for?
- Ages 21 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis Eczema, Aging, Diet Modification
- What is being tested?
- Nutrient-fortified egg and Regular egg with habitual diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSingapore
- Study dates
- 17 Jul 2024to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- English-literate and able to give informed consent in English
- Male and female participants, aged between 21 and 59 inclusive
- Healthy individuals with no underlying condition or on regular medication
- BMI between 18.5-25 kg/m2
- Mild to moderate severity of eczema, which will also be determined using our questionnaires during the screening visit
Who cannot join
- Significant change in body weight (3 kg or more) in the past 3 months
- Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week
- Known food allergy to eggs
- Taking dietary supplements which may impact the study results
- Having gastrointestinal disorders not suitable for the study
- Current smokers
Show all 14Show fewer
- 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
- Taking lipid-lowering and blood pressure-controlling medications for less than 3 years
- Pregnant or lactating women, or planning to conceive in the next 6 months
- Unwilling to stop the medication of eczema during the study, either topical creams or oral medications
- Hierarchical link (professional and familial ties) with the research team members
- Participating in another clinical study
- Having blindness in one eye or more, eye diseases, retinal/lens/optical nerve surgery, or other eye conditions that may impact the study results
- Low-quality macular pigment optical density results were determined during the screening visit.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Department of Food Science and Techonology, Block S13
Singapore, 117550
Si Jia Tan, +65 6516 1656
About this study
Official title: Impact of Regular Consumption of Eggs and Nutrients Fortified Eggs on Eczema Condition in Singapore Individuals With Eczema
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
Read the 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.
- Conditions
- Atopic Dermatitis Eczema, Aging, Diet Modification
- Being tested
- Nutrient-fortified egg, Regular egg with habitual diet
- Keywords
- Atopic Dermatitis, Eczema, Young and Middle-aged adults, Eye health, Antioxidants
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrient-fortified eggDietary supplement
Consumption of nutrient-fortified eggs with habitual diet
Regular egg with habitual dietDietary supplement
Consumption of regular egg with habitual diet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Regular egg with habitual diet |
| 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. Receives: Dietary Supplement: Nutrient-fortified egg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Week 0, week 6, week 12
Secondary outcomes (14)
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.
Measured: Week 0, week 3, week 6, week 9, week 12
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 0, week 3, week 6, week 9, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start17 Jul 2024
- Primary completionNov 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atopic Dermatitis EczemaStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University Hospital, Singapore, Ministry of Education, Singapore
- Responsible party
- Principal investigator, Jung Eun Kim, National University of Singapore
- Investigators
- Jung Eun Kim, PhD, RD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454942
- Sponsor's protocol ID
- S26
- Status last verified
- Jul 2024
- First submitted
- 7 Apr 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 29495607Wilson 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.
PubMed 34157098
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Regular Consumption of Eggs and Nutrients Fortified Eggs on Eczema Condition in Singapore Individuals With Eczema
- ClinicalTrials.gov ID
- NCT06454942
- Acronym / sponsor ID
- S26
- Conditions
- Atopic Dermatitis Eczema, Aging, Diet Modification
- Keywords
- Atopic Dermatitis, Eczema, Young and Middle-aged adults, Eye health, Antioxidants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- National University Hospital, Singapore, Ministry of Education, Singapore
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular egg with habitual diet | Experimental | Dietary Supplement: Regular egg with habitual dietEach 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 | Dietary Supplement: Nutrient-fortified eggEach 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. |
Who may qualify
- Ages
- 21 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- English-literate and able to give informed consent in English
- Male and female participants, aged between 21 and 59 inclusive
- Healthy individuals with no underlying condition or on regular medication
- BMI between 18.5-25 kg/m2
- Mild to moderate severity of eczema, which will also be determined using our questionnaires during the screening visit
Key exclusion criteria (14 listed)
- Significant change in body weight (3 kg or more) in the past 3 months
- Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week
- Known food allergy to eggs
- Taking dietary supplements which may impact the study results
- Having gastrointestinal disorders not suitable for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrient-fortified eggConsumption of nutrient-fortified eggs with habitual diet | Dietary supplement | Nutrient-fortified egg with habitual diet |
| Regular egg with habitual dietConsumption of regular egg with habitual diet | Dietary supplement | Regular egg with habitual diet |
Primary outcome
Skin questionnaires - SCORing Atopic Dermatitis (SCORAD) Index
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
Skin questionnaires - Eczema Area and Severity Index (EASI) scoring system
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
Skin questionnaires - Dermatology life quality index (DLQI)
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
Skin measurement - eczema related
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
Skin carotenoids status
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.
Blood carotenoids levels
Time frame: Week 0, week 6, week 12
Blood carotenoids levels can be measured by High-Performance Liquid Chromatography, unit is μmol/L.
14 secondary outcomes
Eye health - Macular Pigment Optical Density
Time frame: Week 0, week 3, week 6, week 9, week 12
Eye health - Visual acuity
Time frame: Week 0, week 3, week 6, week 9, week 12
Eye health - Photostress recovery time
Time frame: Week 0, week 3, week 6, week 9, week 12
Visual function questionnaire 25
Time frame: Week 0, week 3, week 6, week 9, week 12
Concentration of tumour necrosis factor-α
Time frame: Week 0, week 6, week 12
Concentration of interleukin-6
Time frame: Week 0, week 6, week 12
Concentration of high-sensitivity C-reactive protein
Time frame: Week 0, week 6, week 12
Concentration of fasting blood glucose
Time frame: Week 0, week 6, week 12
Concentration of malondialdehyde
Time frame: Week 0, week 6, week 12
Concentration of 8-isoprostaglandin-F2α
Time frame: Week 0, week 6, week 12
Concentration of insulin
Time frame: Week 0, week 6, week 12
Percentage of glycated hemoglobin
Time frame: Week 0, week 6, week 12
Skin advanced glycation end products levels
Time frame: Week 0, week 3, week 6, week 9, week 12
Blood advanced glycation end products levels
Time frame: Week 0, week 3, week 6, week 9, week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Background: PubMed 29495607Imai 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.
- Background: PubMed 34157098Wilson 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Eun Kim, PhD, RD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrient-fortified egg and Regular egg with habitual diet in people with Atopic Dermatitis Eczema and Aging, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuxin LIANG (6580672043, yuxinliang@u.nus.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin questionnaires - SCORing Atopic Dermatitis (SCORAD) Index (time frame: Week 0, week 3, week 6, week 9, week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06454942, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.