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

NCT06454942 | Recruiting

• 1 other identifier: S26
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Atopic Dermatitis Eczema; Aging; Diet Modification

Keywords

Atopic Dermatitis; Eczema; Young and Middle-aged adults; Eye health; Antioxidants

Outcome Measures

Primary Outcomes (6)

• 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

  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

Secondary Outcomes (14)

• Eye health - Macular Pigment Optical Density

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

• Eye health - Visual acuity

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

• Eye health - Photostress recovery time

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

• Visual function questionnaire 25

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

• Concentration of tumour necrosis factor-α

  Week 0, week 6, week 12

Other Outcomes (5)

• Dietary assessment

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

• Measurement of height

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

• Measurement of blood pressure

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

Study Arms (2)

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.

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.

Dietary Supplement: Nutrient-fortified egg

Interventions

Nutrient-fortified egg DIETARY_SUPPLEMENT

Consumption of nutrient-fortified eggs with habitual diet

Nutrient-fortified egg with habitual diet

Regular egg with habitual diet DIETARY_SUPPLEMENT

Consumption of regular egg with habitual diet

Regular egg with habitual diet

Eligibility Criteria

• Age: 21 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• National University of Singapore: lead
• National University Hospital, Singapore: collaborator
• Ministry of Education, Singapore: collaborator

Study Sites (1)

Department of Food Science and Techonology, Block S13

Singapore, 117550, Singapore

RECRUITING

Related Publications (2)

• 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.

  PMID: 29495607 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.

  PMID: 34157098 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jung Eun Kim, PhD, RD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuxin LIANG

CONTACT

6580672043; yuxinliang@u.nus.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: June 12, 2024
• Study Start: July 17, 2024
• Primary Completion: November 1, 2025
• Study Completion: May 1, 2026
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)