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

Primary Purpose

Eczema, Atopic, Inflammation; Skin, Eczema

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Nutrients-fortified egg
Regular egg
Sponsored by
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Eczema, Atopic focused on measuring Egg, Vitamin D, Vitamin E, Antioxidant, Eczema, Omega-3 long chain polyunsaturated fatty acids

Eligibility Criteria

21 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • National University of Singapore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nutrients-fortified egg

Regular egg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Change in skin hydration level using corneometer
A corneometer is an electronic device used to measure hydration on the skin surface
Change in transepidermal water loss level using tewameter
A tewameter is an electronic device used to measure transepidermal water loss on the skin surface
Change in skin pH level using pH probe
A pH probe is an electronic device used to measure pH levels on the skin surface
Change in skin sebum level using sebumeter
A sebumeter is an electronic device used to measure sebum levels on the skin surface
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
Change in malondialdehyde level
Malondialdehyde concentration in blood samples will be measured
Change in 8-iso-prostaglandin F2α level
8-iso-prostaglandin F2α concentration in blood samples will be measured
Change in interleukin-6 level
Interleukin-6 concentration in blood samples will be measured
Change in tumor necrosis factor α
Tumor necrosis factor α concentration in blood samples will be measured
Change in fasting blood glucose level
Fasting glucose concentration in blood samples will be measured
Change in blood triglyceride level
Triglyceride concentration in blood samples will be measured
Change in blood total cholesterol level
Total cholesterol levels in blood samples will be measured
Change in blood Low-density Lipoprotein-cholesterol (LDL) level
LDL concentration in blood samples will be measured
Change in blood High-density Lipoprotein-cholesterol (HDL) level
HDL concentration in blood samples will be measured

Secondary Outcome Measures

Change in Blood Carotenoid levels using High Performance Liquid Chromatography (HPLC)
Carotenoid concentration in blood samples will be measured
Change in Skin Carotenoid levels using BioPhotonic Scanner
Skin carotenoid levels will be measured from the skin surface
Change in Eye Carotenoid levels using Macular Pigment Scanner
Eye carotenoid levels will be measured using the Macular Pigment Scanner MPSII
Change in Skin Advanced Glycation End-product (AGEs)
Skin AGEs will be quantified using a noninvasive scanner
Change in Blood AGEs
Blood AGEs concentration in blood samples will be measured
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.
Change in Visual Acuity using eye chart
Visual acuity is a measure of visual function and it will be assessed by an investigator
Change in Contrast Sensitivity using eye chart
Contrast sensitivity is a measure of visual function and it will be assessed by an investigator
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

Full Information

First Posted
March 31, 2023
Last Updated
June 13, 2023
Sponsor
National University of Singapore
Collaborators
Ministry of Education, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT05913791
Brief Title
Nutrients-fortified Egg Consumption on Eczema Condition in Individuals With Eczema
Official Title
Impact of Nutrients-fortified Egg Consumption on Eczema Condition in Individuals With Eczema
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
Collaborators
Ministry of Education, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema, Atopic, Inflammation; Skin, Eczema, Hypersensitivity
Keywords
Egg, Vitamin D, Vitamin E, Antioxidant, Eczema, Omega-3 long chain polyunsaturated fatty acids

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrients-fortified egg
Arm Type
Experimental
Arm Description
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.
Arm Title
Regular egg
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrients-fortified egg
Intervention Description
Consumption of 2 cooked nutrients fortified eggs (half-boiled, hard-boiled, or steamed)
Intervention Type
Other
Intervention Name(s)
Regular egg
Intervention Description
Consumption of 2 regular eggs, prepared in the same manner as nutrients-fortified egg, which serves as a placebo comparison.
Primary Outcome Measure Information:
Title
Change in eczema severity using the SCORing Atopic Dermatitis (SCORAD) index
Description
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.
Time Frame
Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
Title
Change in eczema severity using the Eczema Area Severity Index (EASI)
Description
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.
Time Frame
Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
Title
Change in skin quality of life assessment using the Dermatology Life Quality Index (DLQI)
Description
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.
Time Frame
Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
Title
Change in skin hydration level using corneometer
Description
A corneometer is an electronic device used to measure hydration on the skin surface
Time Frame
Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
Title
Change in transepidermal water loss level using tewameter
Description
A tewameter is an electronic device used to measure transepidermal water loss on the skin surface
Time Frame
Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
Title
Change in skin pH level using pH probe
Description
A pH probe is an electronic device used to measure pH levels on the skin surface
Time Frame
Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
Title
Change in skin sebum level using sebumeter
Description
A sebumeter is an electronic device used to measure sebum levels on the skin surface
Time Frame
Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
Title
Change in stratum corneum components via immune dot blot assay
Description
Outermost skin surface components will be extracted to conduct dot blot assays to assess changes during intervention period
Time Frame
Baseline and Week 12
Title
Change in malondialdehyde level
Description
Malondialdehyde concentration in blood samples will be measured
Time Frame
Every 6 weeks (Week 0, Week 6, Week 12)
Title
Change in 8-iso-prostaglandin F2α level
Description
8-iso-prostaglandin F2α concentration in blood samples will be measured
Time Frame
Every 6 weeks (Week 0, Week 6, Week 12)
Title
Change in interleukin-6 level
Description
Interleukin-6 concentration in blood samples will be measured
Time Frame
Every 6 weeks (Week 0, Week 6, Week 12)
Title
Change in tumor necrosis factor α
Description
Tumor necrosis factor α concentration in blood samples will be measured
Time Frame
Every 6 weeks (Week 0, Week 6, Week 12)
Title
Change in fasting blood glucose level
Description
Fasting glucose concentration in blood samples will be measured
Time Frame
Every 6 weeks (Week 0, Week 6, Week 12)
Title
Change in blood triglyceride level
Description
Triglyceride concentration in blood samples will be measured
Time Frame
Every 6 weeks (Week 0, Week 6, Week 12)
Title
Change in blood total cholesterol level
Description
Total cholesterol levels in blood samples will be measured
Time Frame
Every 6 weeks (Week 0, Week 6, Week 12)
Title
Change in blood Low-density Lipoprotein-cholesterol (LDL) level
Description
LDL concentration in blood samples will be measured
Time Frame
Every 6 weeks (Week 0, Week 6, Week 12)
Title
Change in blood High-density Lipoprotein-cholesterol (HDL) level
Description
HDL concentration in blood samples will be measured
Time Frame
Every 6 weeks (Week 0, Week 6, Week 12)
Secondary Outcome Measure Information:
Title
Change in Blood Carotenoid levels using High Performance Liquid Chromatography (HPLC)
Description
Carotenoid concentration in blood samples will be measured
Time Frame
Every 6 weeks (Week 0, Week 6, Week 12)
Title
Change in Skin Carotenoid levels using BioPhotonic Scanner
Description
Skin carotenoid levels will be measured from the skin surface
Time Frame
Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
Title
Change in Eye Carotenoid levels using Macular Pigment Scanner
Description
Eye carotenoid levels will be measured using the Macular Pigment Scanner MPSII
Time Frame
Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
Title
Change in Skin Advanced Glycation End-product (AGEs)
Description
Skin AGEs will be quantified using a noninvasive scanner
Time Frame
Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
Title
Change in Blood AGEs
Description
Blood AGEs concentration in blood samples will be measured
Time Frame
Every 6 weeks (Week 0, Week 6, Week 12)
Title
Change in Eye Visual Function using the NEI VFQ-25
Description
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.
Time Frame
Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
Title
Change in Visual Acuity using eye chart
Description
Visual acuity is a measure of visual function and it will be assessed by an investigator
Time Frame
Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
Title
Change in Contrast Sensitivity using eye chart
Description
Contrast sensitivity is a measure of visual function and it will be assessed by an investigator
Time Frame
Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)
Title
Change in Photostress Recovery Time using eye chart
Description
Photostress recovery assessment is a measure of visual function and it will be assessed by an investigator
Time Frame
Every 3 weeks (Week 0, Week 3, Week 6, Week 9, Week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Eun Kim, PhD
Organizational Affiliation
Food Science and technology, Faculty of Science, National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University of Singapore
City
Singapore
ZIP/Postal Code
117546
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
29941810
Citation
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.
Results Reference
background

Learn more about this trial

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

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