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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	21 Years - 59 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05913791
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National University of Singapore
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jung Eun Kim, PhD
Principal Investigator Affiliation	Food Science and technology, Faculty of Science, National University of Singapore
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Singapore
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eczema, Atopic, Inflammation; Skin, Eczema, Hypersensitivity

Additional Details

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).

Arms & Interventions

Arms

Experimental: 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.

Placebo Comparator: 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.

Interventions

Dietary Supplement: - Nutrients-fortified egg

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

Other: - Regular egg

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

National University of Singapore, Singapore, Singapore

Status

Address

National University of Singapore

Singapore, , 117546

Clinical Trial Finder