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

NCT ID: NCT05913791

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2025-01-31

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).

Conditions

Eczema, Atopic; Inflammation; Skin; Eczema; Hypersensitivity

Study Design

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

Study Groups

Nutrients-fortified egg

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.

Group Type: EXPERIMENTAL

Nutrients-fortified egg

Intervention Type: DIETARY_SUPPLEMENT

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

Regular egg

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.

Group Type: PLACEBO_COMPARATOR

Regular egg

Intervention Type: OTHER

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

Interventions

Nutrients-fortified egg

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

Intervention Type: DIETARY_SUPPLEMENT

Regular egg

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

3. Healthy individuals with no comorbidities 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 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. Had been diagnosed or with a history of gastrointestinal disorders e.g. irritable bowel syndrome, constipation, diverticulitis

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 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, previously diagnosed eye diseases, or have had eye surgery

14. Low quality macular pigment optical density results, determined during screening visit

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

Role: PRINCIPAL_INVESTIGATOR

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

Locations

National University of Singapore

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: BACKGROUND

PMID: 29941810 (View on PubMed)

Other Identifiers

S17

Identifier Type: -

Identifier Source: org_study_id