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

NCT ID: NCT06454942

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-17
• Study Completion Date: 2026-05-31

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

Detailed Description

This is a double-blind, randomized, parallel study and all subjects will complete a 12-week study period. Subjects will be tasked to consume nutrients-fortified eggs and regular eggs daily for 12 weeks. After which, subjects are assessed for changes in carotenoid status, antioxidant and anti-inflammatory biomarkers, skin and eye health measurements, and other biomarkers of health.

Conditions

Atopic Dermatitis Eczema; Aging; Diet Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Regular egg with habitual diet

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.

Group Type: EXPERIMENTAL

Regular egg with habitual diet

Intervention Type: DIETARY_SUPPLEMENT

Consumption of regular egg with habitual diet

Nutrient-fortified egg with habitual diet

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.

Group Type: EXPERIMENTAL

Nutrient-fortified egg

Intervention Type: DIETARY_SUPPLEMENT

Consumption of nutrient-fortified eggs with habitual diet

Interventions

Nutrient-fortified egg

Consumption of nutrient-fortified eggs with habitual diet

Intervention Type: DIETARY_SUPPLEMENT

Regular egg with habitual diet

Consumption of regular egg with habitual diet

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. English-literate and able to give informed consent in English

2. Male and female participants, aged between 21 and 59 inclusive

3. Healthy individuals with no underlying condition or on regular medication

4. BMI between 18.5-25 kg/m2

5. Mild to moderate severity of eczema, which will also be determined using our questionnaires during the screening visit

Exclusion Criteria

1. Significant change in body weight (3 kg or more) in the past 3 months

2. Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week

3. Known food allergy to eggs

4. Taking dietary supplements which may impact the study results

5. Having gastrointestinal disorders not suitable for the study

6. Current smokers

7. 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

8. Taking lipid-lowering and blood pressure-controlling medications for less than 3 years

9. Pregnant or lactating women, or planning to conceive in the next 6 months

10. Unwilling to stop the medication of eczema during the study, either topical creams or oral medications

11. Hierarchical link (professional and familial ties) with the research team members

12. Participating in another clinical study

13. Having blindness in one eye or more, eye diseases, retinal/lens/optical nerve surgery, or other eye conditions that may impact the study results

14. Low-quality macular pigment optical density results were determined during the screening visit.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: collaborator

Ministry of Education, Singapore

OTHER_GOV

Sponsor Role: collaborator

National University of Singapore

OTHER

Sponsor Role: lead

Responsible Party

Jung Eun Kim

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jung Eun Kim, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

National University of Singapore

Locations

Department of Food Science and Techonology, Block S13

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Yuxin LIANG

Role: CONTACT

yuxinliang@u.nus.edu

6580672043

Facility Contacts

Si Jia Tan

Role: primary

+65 6516 1656

References

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.

Reference Type: BACKGROUND

PMID: 29495607 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34157098 (View on PubMed)

Other Identifiers

S26

Identifier Type: -

Identifier Source: org_study_id