NCT05913791

Brief Summary

The study aims to assess the effects of daily consumption of nutrients-fortified eggs on eczema condition in individuals with eczema. It is hypothesised that daily consumption of nutrients-fortified egg, which is rich in antioxidants, will improve eczema conditions in individuals with eczema as compared to consumption of regular eggs.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

March 31, 2023

Last Update Submit

November 7, 2023

Conditions

Eczema, AtopicInflammation; SkinEczemaHypersensitivity

Keywords

EggVitamin DVitamin EAntioxidantEczemaOmega-3 long chain polyunsaturated fatty acids

Outcome Measures

Primary Outcomes (17)

  • Change in eczema severity using the SCORing Atopic Dermatitis (SCORAD) index

    The SCORAD index is a validated composite scoring instrument designed to assess signs and symptoms of atopic dermatitis (AD). Total score ranges from 0 to 103, with higher scores indicating greater severity.

    Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)

  • Change in eczema severity using the Eczema Area Severity Index (EASI)

    The EASI is a validated objective instrument for assessing signs of AD. Total score ranges from 0 to 72, with higher scores indicating greater severity.

    Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)

  • Change in skin quality of life assessment using the Dermatology Life Quality Index (DLQI)

    The DLQI is a validated self-reported instrument assessing the self perception of impact of skin diseases on their quality of life over the previous week. Scores range from 0 to 30, with higher scores indicating greater impairment on quality of life.

    Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)

  • Change in skin hydration level using corneometer

    A corneometer is an electronic device used to measure hydration on the skin surface

    Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)

  • Change in transepidermal water loss level using tewameter

    A tewameter is an electronic device used to measure transepidermal water loss on the skin surface

    Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)

  • Change in skin pH level using pH probe

    A pH probe is an electronic device used to measure pH levels on the skin surface

    Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)

  • Change in skin sebum level using sebumeter

    A sebumeter is an electronic device used to measure sebum levels on the skin surface

    Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)

  • Change in stratum corneum components via immune dot blot assay

    Outermost skin surface components will be extracted to conduct dot blot assays to assess changes during intervention period

    Baseline and Week 12

  • Change in malondialdehyde level

    Malondialdehyde concentration in blood samples will be measured

    Every 6 weeks (Week 0, Week 6, Week 12)

  • Change in 8-iso-prostaglandin F2α level

    8-iso-prostaglandin F2α concentration in blood samples will be measured

    Every 6 weeks (Week 0, Week 6, Week 12)

  • Change in interleukin-6 level

    Interleukin-6 concentration in blood samples will be measured

    Every 6 weeks (Week 0, Week 6, Week 12)

  • Change in tumor necrosis factor α

    Tumor necrosis factor α concentration in blood samples will be measured

    Every 6 weeks (Week 0, Week 6, Week 12)

  • Change in fasting blood glucose level

    Fasting glucose concentration in blood samples will be measured

    Every 6 weeks (Week 0, Week 6, Week 12)

  • Change in blood triglyceride level

    Triglyceride concentration in blood samples will be measured

    Every 6 weeks (Week 0, Week 6, Week 12)

  • Change in blood total cholesterol level

    Total cholesterol levels in blood samples will be measured

    Every 6 weeks (Week 0, Week 6, Week 12)

  • Change in blood Low-density Lipoprotein-cholesterol (LDL) level

    LDL concentration in blood samples will be measured

    Every 6 weeks (Week 0, Week 6, Week 12)

  • Change in blood High-density Lipoprotein-cholesterol (HDL) level

    HDL concentration in blood samples will be measured

    Every 6 weeks (Week 0, Week 6, Week 12)

Secondary Outcomes (9)

  • Change in Blood Carotenoid levels using High Performance Liquid Chromatography (HPLC)

    Every 6 weeks (Week 0, Week 6, Week 12)

  • Change in Skin Carotenoid levels using BioPhotonic Scanner

    Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)

  • Change in Eye Carotenoid levels using Macular Pigment Scanner

    Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)

  • Change in Skin Advanced Glycation End-product (AGEs)

    Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)

  • Change in Blood AGEs

    Every 6 weeks (Week 0, Week 6, Week 12)

  • +4 more secondary outcomes

Study Arms (2)

Nutrients-fortified egg

EXPERIMENTAL

Each subject will be provided with 2 nutrients-fortified eggs from N\&N Agriculture Pte Ltd to consume daily for 12 weeks. They will be instructed to consume the eggs for breakfast with the following preparation methods: hard-boiling, half-boiling and steaming. Subjects are to continue their usual diet.

Dietary Supplement: Nutrients-fortified egg

Regular egg

PLACEBO COMPARATOR

Each subject will be provided with 2 regular eggs to consume daily for 12 weeks. They will be instructed to consume the eggs for breakfast with the following preparation methods: hard-boiling, half-boiling and steaming. Subjects are to continue their usual diet.

Other: Regular egg

Interventions

Nutrients-fortified eggDIETARY_SUPPLEMENT

Consumption of 2 cooked nutrients fortified eggs (half-boiled, hard-boiled, or steamed)

Nutrients-fortified egg
Regular eggOTHER

Consumption of 2 regular eggs, prepared in the same manner as nutrients-fortified egg, which serves as a placebo comparison.

Regular egg

Eligibility Criteria

Age21 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • English-literate and able to give informed consent in English
  • Male and female subjects, aged between 21 and 59 inclusive
  • Healthy individuals with no comorbidities 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 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
  • Had been diagnosed or with a history of gastrointestinal disorders e.g. irritable bowel syndrome, constipation, diverticulitis
  • 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 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, previously diagnosed eye diseases, or have had eye surgery
  • Low quality macular pigment optical density results, determined during screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Singapore

Singapore, 117546, Singapore

Location

Related Publications (1)

  • Ito N, Seki S, Ueda F. The Protective Role of Astaxanthin for UV-Induced Skin Deterioration in Healthy People-A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2018 Jun 25;10(7):817. doi: 10.3390/nu10070817.

    PMID: 29941810BACKGROUND

MeSH Terms

Conditions

Dermatitis, AtopicDermatitisEczemaHypersensitivity

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateImmune System Diseases

Study Officials

  • Jung Eun Kim, PhD

    Food Science and technology, Faculty of Science, National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 31, 2023

First Posted

June 22, 2023

Study Start

March 6, 2023

Primary Completion

July 31, 2023

Study Completion

January 1, 2025

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Hard copy documents containing identifiable participant information will be stored in locked storage cabinets accessible only to members of the NUS research group. These locked storage cabinets are located in Kim lab in NUS. This lab is accessible only to Dr Kim Jung Eun, the Principal Investigator, and Dr Kim's research staff. The lab has a dual access security system, with the first entry point being an electronic lock accessible by an NUS-approved key card and the second is a physical lock. Electronic copies of the data with identifiable participant information stored electronically in NUS OneDrive. Only members of Dr Kim's lab have access to this secured folder. Access to this OneDrive folder is only granted by Dr Kim. All study samples will be de-identified prior to analysis and statistical analyses.

Locations

SG(1)