NCT06547372

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
May 2024Dec 2027

Study Start

First participant enrolled

May 10, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 1, 2026

Status Verified

October 1, 2025

Enrollment Period

3.6 years

First QC Date

August 2, 2024

Last Update Submit

March 26, 2026

Conditions

Keywords

Atopic dermatitisMy Healthy Eating Plateeczemahealthy dietdietmealsfoodsallergicallergyatopicSingaporenutrients

Outcome Measures

Primary Outcomes (1)

  • Healthy Dietary Intervention in Treating Atopic Dermatitis (Reducing SCORAD Scores)

    This study evaluates whether a dietary pattern lower in saturated fats and higher in whole grains, fruits, and vegetables reduces AD severity in young Singaporean adults over a 2-month period, as measured by changes in Scoring Atopic Dermatitis (SCORAD) scores. The SCORAD index is a validated measure of AD severity that integrates lesion extent, clinical signs (erythema, edema, oozing/crusting, excoriation, lichenification, dryness), and patient-reported symptoms. It quantifies affected body surface areas (e.g., head, limbs, trunk), enabling standardized baseline assessment and sensitive monitoring of changes over time.

    Baseline, 2 months (intervention period), and 1 month post-intervention follow-up

Secondary Outcomes (8)

  • Change in skin barrier function assessed by bioengineering measures

    Baseline, 2 months (intervention period), and 1 month post-intervention follow-up

  • Change in dermatology-specific quality of life (DLQI)

    Baseline, 2 months (intervention period), and 1 month post-intervention follow-up

  • Change in atopic dermatitis-related medication utilisation

    Baseline, 2 months (intervention period), and 1 month post-intervention follow-up

  • Height and Weight Measurements

    Baseline, 2 months (intervention period), and 1 month post-intervention follow-up

  • Blood Pressure Measurement

    Baseline, 2 months (intervention period), and 1 month post-intervention follow-up

  • +3 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Dietary Intervention on Atopy

Control

NO INTERVENTION

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.

Interventions

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

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of current, mild-to-moderate atopic dermatitis/eczema at flexural areas
  • to 65 years of age (inclusive) at screening
  • Must be English-literate and able to give informed consent in English
  • Be residing in Singapore and will not be travelling outside of Singapore during the study period
  • Reliable and willing to follow study procedures and be available for the duration of the study
  • Non-smokers (tobacco and e-cigarette)
  • Non-drinker (no regular or frequent consumption of alcohol)
  • Overtly healthy with no pre-existing medical conditions (e.g., diabetes, hypertension, cancer, blood disorders, degenerative/liver/autoimmune/immune/renal diseases, or psychiatric conditions)
  • No food allergies to test foods
  • No needle phobia
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Singapore

Singapore, Singapore, 118177, Singapore

RECRUITING

MeSH Terms

Conditions

Dermatitis, AtopicRhinitis, AllergicEczemaHypersensitivity

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateImmune System DiseasesRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic Diseases

Study Officials

  • Fook Tim CHEW, PhD

    NUS Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Hui Liu, PhD

CONTACT

Jun Jie Lim, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 9, 2024

Study Start

May 10, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 1, 2026

Record last verified: 2025-10

Locations