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Eczema, AtopicNCT05913791

Nutrients-fortified Egg Consumption on Eczema Condition in Individuals With Eczema

A study testing Nutrients-fortified egg and Regular egg in people with Eczema, Atopic and Inflammation; Skin, run by National University of Singapore at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 59 years
Conditions the study is for
Eczema, Atopic, Inflammation; Skin, Eczema
What is being tested?
Nutrients-fortified egg and Regular egg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
1 siteSingapore
Study dates
6 Mar 2023to Jan 2025
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
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

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
  • Had been diagnosed or with a history of gastrointestinal disorders e.g. irritable bowel syndrome, constipation, diverticulitis
  • 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 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • National University of Singapore

    Singapore, 117546

Other trials in Singapore

About this study

Official title: Impact of Nutrients-fortified Egg Consumption on Eczema Condition in Individuals With Eczema

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.

Read the detailed description

Eczema refers to a group of conditions that induces inflammation of the skin. Of which, atopic dermatitis is the most common type. Eczema is common in children, and can continue to adulthood. Eczema is a chronic condition with no known cure.

Anti-inflammatory agents have been shown to protect against atopic dermatitis. Vitamin D, E and polyunsaturated fatty acids are known to confer excellent anti-inflammatory benefits.

This is a double-blinded, randomized, parallel study and all subjects will complete a 12-week study period. The study was designed based on previous research which reported that omega-3 supplementation significantly decreased blood IgE concentration (-29.0 ± 11.1, mean ± SD) compared to placebo supplementation (-7.7 ± 14.6, mean ± SD).

Being tested
Nutrients-fortified egg, Regular egg
Keywords
Egg, Vitamin D, Vitamin E, Antioxidant, Eczema, Omega-3 long chain polyunsaturated fatty acids
Medical subject headings
Dermatitis, Atopic, Dermatitis, Eczema, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrients-fortified eggDietary supplement

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

  • Regular eggOther

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

Study groups in NCT05913791
Study groupRoleWhat they receive
Nutrients-fortified eggExperimentalEach 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.
Receives: Dietary Supplement: Nutrients-fortified egg
Regular eggPlacebo comparatorEach 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.
Receives: Other: Regular egg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. Change in skin hydration level using corneometer

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

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

  5. Change in transepidermal water loss level using tewameter

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

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

  6. Change in skin pH level using pH probe

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

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

  7. Change in skin sebum level using sebumeter

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

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

  8. 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

    Measured: Baseline and Week 12

  9. Change in malondialdehyde level

    Malondialdehyde concentration in blood samples will be measured

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

  10. Change in 8-iso-prostaglandin F2α level

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

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

  11. Change in interleukin-6 level

    Interleukin-6 concentration in blood samples will be measured

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

  12. Change in tumor necrosis factor α

    Tumor necrosis factor α concentration in blood samples will be measured

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

  13. Change in fasting blood glucose level

    Fasting glucose concentration in blood samples will be measured

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

  14. Change in blood triglyceride level

    Triglyceride concentration in blood samples will be measured

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

  15. Change in blood total cholesterol level

    Total cholesterol levels in blood samples will be measured

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

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

    LDL concentration in blood samples will be measured

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

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

    HDL concentration in blood samples will be measured

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

Secondary outcomes (9)
  1. Change in Blood Carotenoid levels using High Performance Liquid Chromatography (HPLC)

    Carotenoid concentration in blood samples will be measured

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

  2. Change in Skin Carotenoid levels using BioPhotonic Scanner

    Skin carotenoid levels will be measured from the skin surface

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

  3. Change in Eye Carotenoid levels using Macular Pigment Scanner

    Eye carotenoid levels will be measured using the Macular Pigment Scanner MPSII

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

  4. Change in Skin Advanced Glycation End-product (AGEs)

    Skin AGEs will be quantified using a noninvasive scanner

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

  5. Change in Blood AGEs

    Blood AGEs concentration in blood samples will be measured

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

  6. Change in Eye Visual Function using the NEI VFQ-25

    The National Eye Institute Visual Functioning Questonnaire-25 (NEI VFQ-25) is a self-reported instrument designed to assess visual disability and health-related quality of life. The overall composite score ranges from 0 to 100, with a higher score indicating better visual function and better quality of life.

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

  7. Change in Visual Acuity using eye chart

    Visual acuity is a measure of visual function and it will be assessed by an investigator

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

  8. Change in Contrast Sensitivity using eye chart

    Contrast sensitivity is a measure of visual function and it will be assessed by an investigator

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

  9. Change in Photostress Recovery Time using eye chart

    Photostress recovery assessment is a measure of visual function and it will be assessed by an investigator

    Measured: Every 3 weeks (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.

  1. First posted22 Jun 2023
  2. Study start6 Mar 2023
  3. Primary completion31 Jul 2023
  4. Study completionJan 2025 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05913791
Sponsor's protocol ID
S17
Status last verified
Nov 2023
First submitted
31 Mar 2023
Last updated
9 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 29941810
  • Hu W, Li S, Li X, Chng ASM, Quek C, Chong Z, Khoo CM, Kim JE. Impact of antioxidants fortified eggs consumption on eye health in individuals with mild to moderate untreated eczema: a randomized controlled trial. Eur J Nutr. 2025 Dec 19;65(1):13. doi: 10.1007/s00394-025-03854-z.

    PubMed 41417237

Questions about this trial

What is this clinical trial studying?

A study testing Nutrients-fortified egg and Regular egg in people with Eczema, Atopic and Inflammation; Skin, 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 9 Nov 2023. 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. Some participants in this study may receive a placebo. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in eczema severity using the SCORing Atopic Dermatitis (SCORAD) index (time frame: Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)). The study lists 17 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 NCT05913791, 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 9 Nov 2023.

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