Dietary Intervention on Atopy

National University of Singapore

Status: Enrolling

Conditions: Atopic Dermatitis; Allergic Diseases; Atopic; Allergic Rhinitis

Treatments: Other: Dietary Intervention on Atopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06547372

NUS-IRB-2024-28

Details and patient eligibility

About

Diet is a key determinant of overall health, with growing evidence associating dietary patterns with allergic diseases. Among these, atopic dermatitis (AD) is of particular interest as it often represents the earliest manifestation of the atopic triad. Investigating dietary interventions in AD therefore provides a relevant model to better understand how diet may influence the onset and progression of allergic disease more broadly.

Full description

Atopic dermatitis (AD) is a chronic inflammatory skin disease that frequently persists into adulthood and substantially impairs quality of life, sleep, and psychosocial well-- being. While pharmacological therapies remain central to management, in- complete responses and concerns regarding long-- term use have prompted interest in complementary, non-- pharmacological strategies. Dietary modification has emerged as a potentially modifiable adjunct; however, adult intervention trials remain limited and have predominantly focused on single-- nutrient supplementation or elimination-- based approaches rather than whole-- diet modification. Evidence from Asian adult populations is particularly scarce.

Building on our prior epidemiological findings demonstrating that frequent intake of saturated fat (SFA)-- rich foods was as- sociated with higher odds of AD exacerbation, whereas greater consumption of fruits, vegetables and dietary fibre was associ- ated with lower odds, we aim to conduct a pilot, parallel-- arm, assessor--blinded randomised controlled trial (RCT). The RCT evaluated whether a culturally adapted healthy dietary pat- tern (HDP), aligned with Singapore's My Healthy Plate (MHP) guidelines, could reduce AD severity as measured by clinical symptoms.

Enrollment: 110 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Presence of current, mild-to-moderate atopic dermatitis/eczema at flexural areas
2. 21 to 65 years of age (inclusive) at screening
3. Must be English-literate and able to give informed consent in English
4. Be residing in Singapore and will not be travelling outside of Singapore during the study period
5. Reliable and willing to follow study procedures and be available for the duration of the study
6. Non-smokers (tobacco and e-cigarette)
7. Non-drinker (no regular or frequent consumption of alcohol)
8. Overtly healthy with no pre-existing medical conditions (e.g., diabetes, hypertension, cancer, blood disorders, degenerative/liver/autoimmune/immune/renal diseases, or psychiatric conditions)
9. No food allergies to test foods
10. No needle phobia
11. Be willing to follow the instruction provided by the investigators on the use of any moisturiser, cosmetics, and/or topical cream on the skin throughout the entire duration of the study.

Exclusion criteria

1. Concurrent participation in other research studies
2. Pregnancy or lactating individuals
3. Known or ongoing psychiatric disorders within 3 years
4. Known severe nutritional deficiency
5. Vegetarian/vegans (as meat will be included in the diet)
6. Individuals who made a significant dietary change in the past 12 months
7. Having a pre-existing dietary restriction that would interfere with the adherence to a whole diet meal
8. Regular use of strong medication (western and/or traditional), therapies, and alternative medications
9. Regular nutritional supplements in the past 12 months Regular consumption of oral contraceptive pills and/or steroid hormones
10. Antibiotic use in the past 2 months
11. Any long-term hospitalisation or surgery during the 6 months before enrolment in study
12. Significant change in weight (+/- 5.0%) during the past month
13. History of bleeding diathesis or coagulopathy (or any bleeding disorders)
14. Having donated blood of more than 500 mL within 4 weeks of study enrolment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

Intervention

Experimental group

Description:

Throughout the 2-month intervention period, only participants in the intervention arm will be provided with bento-styled meals for lunch and dinner daily. The meals will encompass a variety of nutrient-rich ingredients, including whole grains, lean proteins, an array of fruits and vegetables, and healthy fats. The food will be prepared by a licensed food catering service.

Treatment:

Other: Dietary Intervention on Atopy

Control

No Intervention group

Description:

The control group will not receive the meals provided by our study nor will they receive any nutritional advice. Instead, they will continue following their usual dietary habits and patterns throughout the study period.