Dietary Intervention on Atopy

NCT ID: NCT06547372

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-10
• Study Completion Date: 2025-04-30

Brief Summary

Dietary habits play an indispensable role in maintaining overall health and well-being. In recent years, emerging research has underscored the importance of dietary factors on a range of diseases which include allergic (atopic) diseases such as atopic dermatitis (AD). Conducting a dietary intervention study related to AD can provide valuable insights into the relationship between diet and the development or management of this particular allergic skin condition.

Detailed Description

Atopic dermatitis (AD) is a chronic inflammatory skin disease highly associated with xerosis and pruritus, affecting a substantial portion of individuals of all age groups. The European Academy of Allergy and Clinical Immunology (EAACI) Task Force on Diet and Immunomodulation also emphasized the role of dietary patterns as an important indicator to study the risk of allergic diseases. Furthermore, emerging epidemiological findings and randomised controlled trials (RCT) in recent decades strongly suggest that diet may play a pivotal role in not only triggering and exacerbating AD but also in its effective management.

Preliminary cross-sectional findings in a large independent allergic cohort of 13,561 young Chinese Adults from Singapore and Malaysia highlighted that a frequent intake of high-fat foods such as margarine, butter, seafood, and burgers and fast foods is strongly associated with a higher risk of AD. A diet consisting mainly of high-fat foods, or a high-fat diet as shown by a derived amount- and score-based dietary indices was strongly associated with a higher risk for severe AD even controlling for potential confounding factors like age, sex, body mass index (BMI), lifestyle habits, and genetic predisposition. On the other hand, a frequent adherence to a plant-based food dietary pattern consisting of fruit, vegetables, and cereals was associated with a lowered risk of severe AD. Overall, these compelling findings aligned with evidence-based guidelines such as "My Healthy Eating Plate, Singapore", a visual guide designed to promote a balanced and nutritious dietary pattern specific to the Singaporean context.

In conclusion, a whole diet dietary intervention on AD that adhere to established dietary recommendations such as "My Healthy Eating Plate, Singapore", may offer a promising avenue for individuals seeking to i) improve AD symptoms, ii) improve skin health, and iii) improve quality-of-life.

Conditions

Atopic Dermatitis; Atopic

Study Design

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

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Dietary Intervention on Atopy

Intervention Type: OTHER

The primary aim of this dietary intervention study is to assess the effectiveness of a dietary pattern characterized by lower saturated fats, higher wholegrains, fruit, and vegetables in reducing the severity of AD in young Singapore adults, as measured by changes in Scoring Atopic Dermatitis (SCORAD) scores, over a 2-month intervention period.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dietary Intervention on Atopy

The primary aim of this dietary intervention study is to assess the effectiveness of a dietary pattern characterized by lower saturated fats, higher wholegrains, fruit, and vegetables in reducing the severity of AD in young Singapore adults, as measured by changes in Scoring Atopic Dermatitis (SCORAD) scores, over a 2-month intervention period.

Intervention Type: OTHER

Eligibility Criteria

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 not apply 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University of Singapore

OTHER

Sponsor Role: lead

Responsible Party

CHEW Fook Tim

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fook Tim CHEW, PhD

Role: PRINCIPAL_INVESTIGATOR

NUS Singapore

Locations

National University of Singapore

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Mei Hui LIU, PhD

Role: CONTACT

fstlmh@nus.edu.sg

65163523 ext. (+65)

Jun Jie LIM, BSc

Role: CONTACT

lim.jun.jie@u.nus.edu

65161685 ext. (+65)

Facility Contacts

Jun Jie LIM, BSc

Role: primary

lim.jun.jie@u.nus.edu

65161685 ext. +65

Other Identifiers

NUS-IRB-2024-28

Identifier Type: -

Identifier Source: org_study_id