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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-59
SponsorNational University of Singapore

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nutrient-fortified egg

    Dietary supplement

    Consumption of nutrient-fortified eggs with habitual diet

  • Regular egg with habitual diet

    Dietary supplement

    Consumption of regular egg with habitual diet

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Regular egg with habitual dietExperimental treatment 1 intervention
Group B: Nutrient-fortified egg with habitual dietExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Week 0, week 3, week 6, week 9, week 12
2

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

Time frame
Week 0, week 3, week 6, week 9, week 12
3

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

Time frame
Week 0, week 3, week 6, week 9, week 12
4

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

Time frame
Week 0, week 3, week 6, week 9, week 12

Secondary outcomes

1

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.

Time frame
Week 0, week 3, week 6, week 9, week 12
2

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.

Time frame
Week 0, week 3, week 6, week 9, week 12
3

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

Time frame
Week 0, week 3, week 6, week 9, week 12
4

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.

Time frame
Week 0, week 3, week 6, week 9, week 12

Other outcomes

1

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.

Time frame
Week 0, week 3, week 6, week 9, week 12
2

Measurement of height

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
3

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.

Time frame
Week 0, week 3, week 6, week 9, week 12
4

Measurement of weight

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Singapore

Lead sponsor

National University Hospital, Singapore

Collaborator

Ministry of Education, Singapore

Collaborator